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PubMedDate not supplied

Ciprofloxacin ophthalmic solution versus rifamycin ophthalmic solution for the treatment of conjunctivitis and blepharitis.

The efficacy and safety of ciprofloxacin (0.3%) ophthalmic solution and rifamycin (1%) ophthalmic solution for the treatment of bacterial conjunctivitis and blepharitis was compared in this randomized, double-masked, parallel-group study. Forty-one patients, 19 on ciprofloxacin and 22 on rifamycin, were culture-positive on admission and evaluated for efficacy. There was clinical improvement in more than 90% of patients in each group at the end of the seven-day treatment period. However, clinical cure rates on day 7 appeared to be higher with ciprofloxacin (53%) than rifamycin (23%; p = 0.061, Mann-Whitney test). Bacteriological eradication rates were comparable: the infecting organisms were eradicated in 68% of patients on ciprofloxacin and 77% with rifamycin. There were no serious adverse reactions to either treatment. One patient in each group was withdrawn on account of a mild allergy. In conclusion, topical ciprofloxacin was effective and well tolerated and would be a particularly useful agent for the treatment of bacterial conjunctivitis and blepharitis.

Acute Disease↗
PubMed1982

Trimethoprim-polymyxin ophthalmic solution versus chloramphenicol ophthalmic solution in the treatment of bacterial conjunctivitis.

Forty patients with a diagnosis of presumptive bacterial conjunctivitis were treated with either trimethoprim-polymyxin or chloramphenicol ophthalmic solutions in a randomized, double-blind trial. No significant differences could be demonstrated between the results of 7-days' treatment with the two preparations and both solutions were found to be effective in improving the signs and symptoms of surface ocular bacterial infection. No adverse reactions were reported in either treatment group.

Adolescent↗
PubMed1999

Comparative evaluation of olopatadine ophthalmic solution (0.1%) versus ketorolac ophthalmic solution (0.5%) using the provocative antigen challenge model.

OBJECTIVE: This study was conducted to compare the efficacy and safety of olopatadine ophthalmic solution (0.1%) with ketorolac ophthalmic solution (0.5%) in a clinical model of acute allergic conjunctivitis. Olopatadine is a dual acting H1 histamine receptor antagonist and a mast cell stabilizer, shown to be effective in treating allergic conjunctivitis. Ketorolac is a non-steroidal anti-inflammatory drug approved in the United States for the relief of ocular itching associated with seasonal allergic conjunctivitis. METHODS: The provocative antigen challenge model was used in this randomized, double-blind, single-center, crossover study. The allergen and concentration that consistently elicited a positive allergic reaction was used for challenge. After at least 14 days, subjects were randomized to receive either olopatadine in one eye and placebo in the contralateral eye, or ketorolac in one eye and placebo in the contralateral eye. Twenty-seven minutes after drug instillation subjects were challenged with allergen. At 3, 10, and 20 minutes following allergen challenge, subjects graded ocular itching and were assessed for hyperemia in conjunctival, ciliary, and episcleral vessel beds. Approximately 14 days later, subjects received the alternate treatment in one eye and placebo in the contralateral eye. They were again challenged with allergen and their responses were rated in the same manner. RESULTS: Olopatadine significantly (p < 0.0001) reduced both ocular itching and hyperemia in all three vessel beds compared to placebo at all time points tested following allergen challenge. Ketorolac did not significantly reduce itching and showed a trend of increased hyperemia compared to placebo. Olopatadine was significantly (p < 0.001) more effective than ketorolac in reducing hyperemia and ocular itching at all time points and was also significantly (p < 0.05) more comfortable than ketorolac as reported by subjects immediately following drug instillation. CONCLUSION: The study demonstrated that olopatadine is effective and safe in preventing and treating ocular itching and hyperemia associated with acute allergic conjunctivitis and is more effective and more comfortable than ketorolac.

Acute Disease↗
PubMed1999

Comparison of the topical ocular antiallergic efficacy of emedastine 0.05% ophthalmic solution to ketorolac 0.5% ophthalmic solution in a clinical model of allergic conjunctivitis.

PURPOSE: To compare the clinical efficacy of emedastine ophthalmic solution to that of ketorolac ophthalmic solution using a conjunctival allergen challenge model. METHODS: The conjunctival allergen challenge model was used in this randomized, double-masked, single center, crossover study. The titer of allergen that elicited a positive allergic reaction was selected. After at least 14 days, 36 subjects were randomized into two groups of 18 to receive either emedastine in one eye and placebo in the contralateral eye, or ketorolac in one eye and placebo in the contralateral eye. Ten minutes after drug instillation, subjects were challenged with antigen. At 3, 10 and 20 minutes following challenge subjects graded ocular itching and were assessed for hyperemia in conjunctival, ciliary, and episcleral vessel beds. Approximately 14 days later, subjects received the alternate treatment in one eye and placebo in the contralateral eye. They were again challenged with allergen and their responses were rated in the same manner. Ocular discomfort was assessed by the subjects after administration of each study drug. RESULTS: Emedastine significantly (p < 0.05) inhibited ocular itching and redness in vascular beds following topical ocular administration. In contrast, ketorolac failed to significantly inhibit ocular itching or redness in this study. Patient assessment of comfort indicated emedastine was significantly (p < 0.05) more comfortable than ketorolac upon topical ocular administration. CONCLUSION: Emedastine is superior to ketorolac in controlling itching and redness, the cardinal symptom and sign of allergic conjunctivitis.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed2003

A phase III clinical trial of 0.5% levofloxacin ophthalmic solution versus 0.3% ofloxacin ophthalmic solution for the treatment of bacterial conjunctivitis.

OBJECTIVE: To compare the efficacy and safety of 0.5% levofloxacin ophthalmic solution (QUIXIN) with 0.3% ofloxacin ophthalmic solution for the treatment of bacterial conjunctivitis. DESIGN: Prospective, randomized, active-controlled, double-masked, multicenter study. PARTICIPANTS: Four hundred twenty-three patients with a clinical diagnosis of bacterial conjunctivitis were enrolled. METHODS: Patients were randomly assigned to receive either 0.5% levofloxacin (n = 211) or 0.3% ofloxacin (n = 212) for 5 days (every 2 hours on days 1 and 2 and every 4 hours on days 3-5). Conjunctival cultures were obtained, and ocular signs and symptoms were evaluated on day 1 (baseline), days 3 to 5 (interim), and days 6 to 10 (final). End point was defined as the last evaluable observation. MAIN OUTCOME MEASURES: Primary microbial and clinical outcomes were based on culture results and resolution of cardinal signs, respectively. Secondary efficacy assessments included evaluations of ocular signs and symptoms. RESULTS: Two hundred eight patients (levofloxacin, n = 109; ofloxacin, n = 99) were evaluated for efficacy. Microbial eradication rates were significantly greater in the 0.5% levofloxacin treatment group compared with the 0.3% ofloxacin group at both the final visit (89% vs. 80%, P = 0.034) and at end point (90% vs. 81%; P = 0.038). Treatment with 0.5% levofloxacin was significantly more effective in resolving photophobia than was 0.3% ofloxacin treatment (94% vs. 73%, P = 0.006). Both study medications were well tolerated, with a low incidence of adverse events. CONCLUSIONS: Although clinical cure rates in the 0.5% levofloxacin and 0.3% ofloxacin treatment groups were similar, a 5-day treatment regimen with 0.5% levofloxacin achieved microbial eradication rates that were statistically superior to those attained with 0.3% ofloxacin. Despite the higher concentration of active drug in 0.5% levofloxacin versus 0.3% ofloxacin, there was no difference between treatment groups in the incidence of treatment-related adverse events.

Adolescent↗
PubMed2002

A comparison of the efficacy and tolerability of olopatadine hydrochloride 0.1% ophthalmic solution and cromolyn sodium 2% ophthalmic solution in seasonal allergic conjunctivitis.

BACKGROUND: Treatments for allergic conjunctivitis have various mechanisms of action. Cromolyn sodium stabilizes conjunctival mast cells by preventing calcium influx across the cell membrane, whereas olopatadine hydrochloride is both an antihistamine and a mast cell stabilizer. OBJECTIVE: This study compared the efficacy and tolerability of olopatadine and cromolyn in controlling the ocular signs and symptoms of seasonal allergic conjunctivitis. METHODS: This was a multicenter, randomized, double-masked, parallel-group trial. One group instilled olopatadine 0.1% ophthalmic solution and placebo BID, and the other instilled cromolyn 2% ophthalmic solution QID, both for 6 weeks. The formulation of cromolyn used in this study is currently available only in Europe and Australia. RESULTS: The intent-to-treat efficacy and safety analyses included 185 patients, 91 in the olopatadine group and 94 in the cromolyn group. At 30 minutes after the first instillation, respective decreases of approximately 30% and approximately 20% were reported in self-rated ocular itching and redness with both treatments; by 4 hours, itching had decreased by approximately 38% in both groups. Differences between treatments were not statistically significant. At 4 hours, redness had decreased by approximately 38% and approximately 26% in the respective treatment groups. By day 42, both treatments had produced significant reductions from baseline in ocular signs and symptoms; however, the reductions in itching and redness were significantly greater with olopatadine compared with cromolyn (both variables, P < 0.05). The difference in physicians' impression of overall improvement on days 30 and 42 significantly favored olopatadine over cromolyn (both days, P < 0.05). Most patients (62.2%) had reacted positively to grass pollen at baseline. The regression slopes correlating itching and redness with pollen count were 5 times lower for olopatadine compared with cromolyn (P = 0.002 and P = 0.016, respectively), indicating that olopatadine's efficacy increased as the pollen count increased. CONCLUSIONS: Six weeks' instillation of olopatadine 0.19% ophthalmic solution BID had a significantly greater effect on the ocular signs and symptoms of allergic conjunctivitis compared with 6 weeks' instillation of cromolyn 2% ophthalmic solution QID. Both treatments were well tolerated by patients in all age groups; however, olopatadine appeared to have better local tolerability in children aged <11 years.

Adolescent↗
PubMed2001

Evaluation of the efficacy of olopatadine hydrochloride 0.1% ophthalmic solution and azelastine hydrochloride 0.05% ophthalmic solution in the conjunctival allergen challenge model.

BACKGROUND: Olopatadine hydrochloride 0.1% ophthalmic solution and azelastine hydrochlofide 0.05% ophthalmic solution are 2 topical antiallergic agents indicated for the treatment of itching of the eye associated with allergic conjunctivitis. Olopatadine has recently received US Food and Drug Administration (FDA) approval for an expanded indication for the treatment of signs and symptoms of allergic conjunctivitis, including itching, tearing, eyelid swelling, redness, and chemosis. OBJECTIVE: The purpose of this study was to compare the efficacy of olopatadine hydrochloride versus azelastine hydrochloride and placebo (artificial tears) in the conjunctival allergen challenge (CAC) model. METHODS: This was a prospective, randomized, double-masked, contralaterally controlled, multicenter, allergen-challenge study. Itching was chosen as the primary efficacy variable since it is the only FDA-approved indication these 2 agents have in common. Subjects with a history of allergic conjunctivitis who responded to the CAC at screening visits 1 and 2 were randomized to 1 of 3 treatment groups: olopatadine in 1 eye and azelastine in the other eye; olopatadine in 1 eye and placebo in the other eye; or azelastine in 1 eye and placebo in the other eye. At the assessment visit (visit 3), subjects received masked study medication according to the randomization scheme. After 5 minutes, subjects were bilaterally challenged with the allergen concentration that had elicited a positive conjunctival allergic response at visits 1 and 2. Immediately after challenge, subjects gave itching assessments (scale, 0 = no itching to 4 = severe itching) every 30 seconds for a total period of 20 minutes. Mean itching scores for all eyes were compared by treatment. Mean itching scores at each time point were compared between treatments using 2 sample t tests. RESULTS: Of the 180 subjects screened, 111 responded to the CAC at visits 1 and 2 and completed the study; 65% (72/111) of patients were female, 87% (97/111) were white, and 49% (54/111) had brown irides. The mean age was approximately 40 years. Seventy-three eyes were treated with olopatadine, 75 with azelastine, and 74 with placebo. A single dose of 1 of the 3 study medications per eye was well tolerated by all subjects. Both treatments were significantly more effective than placebo at reducing itching postchallenge. Olopatadine was significantly more effective than azelastine in reducing itching at 3.5 minutes through 20 minutes postchallenge (average mean unit difference of -0.31; P < 0.05) in the CAC model. CONCLUSION: In this population, olopatadine was significantly more effective than azelastine in the management of itching associated with allergic conjunctivitis in the CAC model.

Adult↗
PubMed2002

Randomized, double-masked, placebo-controlled comparison of the efficacy of emedastine difumarate 0.05% ophthalmic solution and ketotifen fumarate 0.025% ophthalmic solution in the human conjunctival allergen challenge model.

BACKGROUND: Emedastine difumarate 0.05% ophthalmic solution and ketotifen fumarate 0.025% ophthalmic solution are 2 topical antiallergic agents available in the United States and other countries. Emedastine is indicated for the temporary relief of the signs and symptoms of allergic conjunctivitis. Ketotifen is indicated for the temporary relief of ocular itching caused by allergic conjunctivitis. OBJECTIVE: The purpose of this study was to compare the efficacy of these agents in the temporary relief of ocular itching due to allergic conjunctivitis. The 2 agents were compared with each other and with placebo (artificial tears) using the conjunctival allergen challenge (CAC) model. METHODS: This was a single-center, randomized, double-masked, placebo-controlled study. At visit 1, CAC was performed on eligible subjects to identify the dose required to elicit a positive allergic reaction. Subjects returned after 7 days for visit 2 to confirm the allergen dose. On day 14 (+/-3) of the study, enrolled subjects were randomized to 1 of 3 treatment groups: emedastine in I eye and placebo in the other, ketotifen in 1 eye and placebo in the other, or emedastine in 1 eye and ketotifen in the other. In 25 subjects, bilateral CAC was performed 5 minutes after study medication instillation. In a second group of 20 subjects, CAC was performed 15 minutes after medication instillation. Itching was graded according to a standardized 5-point scale (0 = none to 4 = severe itching) at 3, 5, and 10 minutes postchallenge. Differences in efficacy scores between treatments and versus placebo were compared using 2-sample t tests of equal variance. RESULTS: A total of 45 patients (mean age, 41.2 years) received treatment: 16 received emedastine in 1 eye and ketotifen in the other; 14 received emedastine in 1 eye and placebo in the other; and 15 received ketotifen in 1 eye and placebo in the other. Both emedastine and ketotifen significantly inhibited itching (P < 0.05) compared with placebo at all time points after the 5- and 15-minute CAC. Mean raw scores for the active treatments were not statistically different. The mean itching efficacy scores were also not statistically different between active treatments. No adverse events were reported in this study. CONCLUSION: The results of this study suggest that emedastine and ketotifen are not significantly different with respect to anti-itching efficacy in the CAC model of acute allergic conjunctivitis.

Allergens↗
PubMed2000

A comparison of the relative efficacy and clinical performance of olopatadine hydrochloride 0.1% ophthalmic solution and ketotifen fumarate 0.025% ophthalmic solution in the conjunctival antigen challenge model.

OBJECTIVE: The purpose of this study was to compare the relative efficacy and clinical performance of olopatadine hydrochloride 0.1% ophthalmic solution and ketotifen fumarate 0.025% ophthalmic solution in the conjunctival antigen challenge model. METHODS: This was a prospective, randomized, double-masked, contralaterally controlled, single-center, antigen challenge study. Of the 53 subjects screened, 32 were enrolled and completed the study. The study comprised 3 visits. Primary efficacy variables were ocular itching (assessed at visits 2 and 3) and subject satisfaction (assessed at visit 3). Tolerability variables were slit-lamp findings (all visits), visual acuity (all visits), ocular comfort after drug instillation (visit 3), and adverse events (visits 2 and 3). At visit 1, the antigen concentration that elicited a positive ocular allergic response was determined, and this concentration was confirmed at visit 2. Subjects graded itching on a 5-point scale at 3, 5, and 10 minutes postchallenge. The scores from this visit were used as baseline scores and compared with scores from visit 3 to determine drug efficacy. At visit 3, subjects were randomly assigned to 2 treatment groups. Group A received 1 drop of olopatadine in the right eye and I drop of ketotifen in the left eye. Group B received 1 drop of olopatadine in the left eye and 1 drop of ketotifen in the right eye. Following drug instillation, the subjects assessed the comfort level in each eye. Twelve hours after instillation, subjects were challenged with the antigen concentration that elicited a positive response at the previous visits. Itching was subjectively graded at 3, 5, and 10 minutes postchallenge. Subjects were asked to choose which therapy they were more satisfied with. RESULTS: Twelve hours after administration, efficacy scores for olopatadine were significantly higher than those for ketotifen at 3 and 5 minutes postchallenge (1.84 and 1.75 vs 1.25 and 1.34; P < 0.05). Olopatadine-treated eyes were rated significantly more comfortable than those treated with ketotifen immediately after drug instillation (1.25 vs 2.09; P < 0.05) and 12 hours later, as measured by patient ratings of ocular comfort. Of the 22 subjects who had a preference, 16 (73%) were more satisfied with olopatadine than with ketotifen. CONCLUSIONS: Olopatadine is more effective than ketotifen in reducing the itching associated with allergic conjunctivitis in the antigen challenge model. Olopatadine caused less ocular discomfort than ketotifen and was preferred by approximately 3 times as many patients as was ketotifen.

Allergens↗
PubMed2000

Comparison of the clinical efficacy and comfort of olopatadine hydrochloride 0.1% ophthalmic solution and nedocromil sodium 2% ophthalmic solution in the human conjunctival allergen challenge model.

BACKGROUND: Mast cell stabilizers, such as the ocular antiallergic agent nedocromil sodium 2% ophthalmic solution, are not rapid acting and often require a loading period of > or =2 weeks for maximal efficacy. Olopatadine hydrochloride 0.1% ophthalmic solution is a member of a new class of topical antiallergic agents that have combined antihistaminic and mast cell-stabilizing properties. OBJECTIVE: The purpose of this study was to compare the clinical efficacy and comfort of olopatadine with those of nedocromil in the conjunctival allergen challenge model. METHODS: This was a single-center, 3-visit, randomized, double-masked, contralaterally controlled study. Seventy-five subjects with a history of allergic conjunctivitis were screened, and the 52 who responded to conjunctival allergen challenge at visits I and 2 were randomized by eye to receive olopatadine, nedocromil, or placebo (a "natural tears" lubricant eye drop). Because nedocromil may require a 2-week loading period for maximal efficacy, the eyes assigned to that agent received nedocromil for 14 days (between visits 2 and 3), whereas the eyes assigned to olopatadine or placebo received placebo during this period. Throughout the loading phase, subjects instilled 1 drop of the assigned masked medication in each eye twice daily. At the assessment visit (visit 3), subjects received I drop of masked olopatadine, nedocromil, or placebo in each eye and were asked to rate the comfort of each drop on a scale from 0 to 8. Fifteen minutes after instillation of medication, subjects were challenged with the allergen concentration that had elicited a positive conjunctival allergic response at the previous visits. Subjects then scored their itching on a scale from 0 to 4 at 3, 5, and 10 minutes after challenge. Mean itching scores for all eyes were compared by treatment. Paired t tests were performed on the mean itching and ocular comfort scores at each time point. At the end of the study, subjects were asked which treatment they preferred in terms of comfort and efficacy. RESULTS: Forty-nine subjects completed the study. Forty eyes received olopatadine, 36 received nedocromil, and 22 received placebo. Olopatadine was clinically and statistically superior to nedocromil at reducing itching in the conjunctival allergen challenge model (mean unit difference: -1.60 at 3 minutes, -1.68 at 5 minutes, -1.19 at 10 minutes; P < 0.001). One drop of olopatadine was more efficacious than 29 drops of nedocromil. Olopatadine-treated eyes were rated as being significantly more comfortable than nedocromil-treated eyes (0.73 vs 1.55; P = 0.034). Of the 14 subjects treated with olopatadine and nedocromil who stated a preference, 10 (71%) were more satisfied with olopatadine than with nedocromil. CONCLUSION: In the conjunctival allergen challenge model, olopatadine was more efficacious and comfortable than nedocromil in reducing the itching associated with allergic conjunctivitis.

Conjunctivitis, Allergic↗
PubMed1991

Double-blind trial of pentigetide ophthalmic solution, 0.5%, compared with cromolyn sodium, 4%, ophthalmic solution for allergic conjunctivitis.

Fifty patients (25 per group) with the signs and symptoms of allergic conjunctivitis confirmed by positive skin test enrolled in this randomized, double-blind, parallel group, 2-week comparison of pentigetide, 0.5%, ophthalmic solution (Pentyde) and cromolyn sodium, 4%, USP ophthalmic solution (Opticrom). The physician and the patient rated the patient's overall ocular condition on days 3, 8, and 15. On day 15 both the physician and the patients rated the pentigetide group as significantly (Chi-square, P less than .05) more improved than the cromolyn sodium group. The physician rated independently conjunctival symptoms and ocular signs at days 1, 3, 8, and 15. Improvement in signs and symptoms favored pentigetide in the majority of comparisons to cromolyn sodium (14 of 18). The pentigetide group showed significantly (ANOVA, P less than .05) greater improvement in hyperemia, edema, lacrimation, and blurred vision/photophobia. Patients completed daily diaries for seven symptoms. At the end of the study, comparisons to baseline between groups favored the pentigetide group for six of the seven symptoms; for itching, improvement favored significantly (ANOVA, P less than .05) the pentigetide group. The mean severity of all symptoms decreased by 64% in the pentigetide group as compared with a decrease of 46% in the cromolyn sodium group. Adverse experiences were minor and comparable in both groups. No clinically abnormal changes were noted for visual acuity, intraocular pressure, or common laboratory tests. This double-blind, active-controlled trial demonstrates that pentigetide, 0.5%, ophthalmic solution is safe and effective in the treatment of allergic conjunctivitis.

Adolescent↗
PubMed1976

Intraocular pressure decrease in normal volunteers following timolol ophthalmic solution.

Timolol ophthalmic solutions 0.5 per cent, 1.0 per cent, and 1.5 per cent lowered intraocular pressures significantly in normal human volunteers. Maximum lowering of the intraocular pressures was reached at two hours with the 0.5 per cent solution of timolol and at one hour with the 1.0 per cent and 1.5 per cent timolol ophthalmic solutions. The effect lasted the full seven hours of observations. No objective or subjective evidence of ocular irritation could be attributed to the drug. A single dose of timolol applied topically to the eyes of normal human volunteers had no effect on pupillary size, visual acuity, blood pressure, or pulse rate.

Adrenergic beta-Antagonists↗
PubMedDate not supplied

Comparison of lodoxamide 0.1% ophthalmic solution and levocabastine 0.05% ophthalmic suspension in vernal keratoconjunctivitis.

PURPOSE: To compare the clinical efficacy and safety of lodoxamide 0.1% ophthalmic solution with levocabastine 0.05% ophthalmic suspension, each given four times daily (QID) for three months to patients with vernal keratoconjunctivitis (VKC). METHODS: The study was conducted multinationally according to a triple-masked parallel design in 95 VKC patients, with assessments at baseline then monthly during the three months of treatment. The primary efficacy variables were a Physician's Clinical Judgement Scale and a Patient's Overall Judgement Scale of improvements from baseline. Signs and symptoms of VKC were also assessed. RESULTS: Both primary efficacy variables showed significantly greater overall improvement of VKC from baseline with lodoxamide than levocabastine. The superiority of lodoxamide was demonstrated by the Physician's Clinical Judgement Scale at months 2 and 3, with a trend, at month 1, and by the Patient's Overall Judgement Scale at months 1, 2 and 3. All signs and symptoms of VKC improved significantly from baseline at all time points, regardless of treatment (p<0.001). However, relative to levocabastine, conjunctival discharge, photophobia and lacrimation were significantly reduced by lodoxamide at months 1, 2 and 3, itching at months 2 and 3, and bulbar conjunctiva at month 3. The temporal improvement of superior tarsal papillae did not differ significantly between treatments. Both were well tolerated. CONCLUSIONS: Lodoxamide 0.1% and levocabastine 0.05% eye drops, instilled four times daily for three months, were effective, safe and well tolerated by patients with VKC, but lodoxamide was significantly superior to levocabastine.

Adolescent↗
PubMed2000

Safety and efficacy comparison of emedastine 0.05% ophthalmic solution compared to levocabastine 0.05% ophthalmic suspension in pediatric subjects with allergic conjunctivitis. Emadine Study Group.

PURPOSE: To determine the efficacy and tolerance of emedastine 0.05% ophthalmic solution compared to levocabastine 0.05% ophthalmic suspension in pediatric subjects. METHODS AND MATERIALS: In a randomized, double-masked, parallel controlled study, emedastine 0.05% ophthalmic solution BID was compared to levocabastine 0.05% ophthalmic suspension BID, for control of the signs and symptoms of allergic conjunctivitis in pediatric subjects ages 3-16. Subjects who met all inclusion and exclusion criteria received masked study medication with instructions to instill drops twice daily, in the morning and evening. A diary was completed by the parents four times daily for the first two and last two weeks of the study. Treatment lasted 42 days. Drug efficacy was assessed at the initial administration in the office at Day 0 and after 3, 7, 14, 30 and 42 days. RESULTS: Overall results showed both drugs have an effect and that emedastine was significantly superior (p < 0.05) to levocabastine for the relief of chemosis on Days 14, 30 and 42; of itching on follow-up Days 30 and 42 (p < 0.05); of redness on Days 30 and 42; for eyelid swelling on Days 14 and 30; and for physician's impression score on Days 7, 14, 30 and 42. CONCLUSION: These results confirm previous preclinical and clinical data on the potent and long acting efficacy of this promising new ophthalmic anti-allergic drug, emedastine in pediatric subjects.

Adolescent↗
PubMed2000

Emedastine ophthalmic solution 0.05% versus levocabastine ophthalmic suspension 0.05% in the treatment of allergic conjunctivitis using the conjunctival allergen challenge model.

PURPOSE: To compare a new ocular antihistamine, emedastine difumarate (Emadine Ophthalmic Solution 0.05%; Alcon Laboratories, Fort Worth, Texas), with the marketed ocular antihistamine, levocabastine hydrochloride (Livostin Ophthalmic Suspension 0.05%; CIBA Vision, Atlanta, Georgia), in the treatment of allergic conjunctivitis after conjunctival allergen challenge. METHODS: We performed a prospective, double-masked, randomized, contralateral eye study comparing emedastine 0.05% in one eye with levocabastine 0. 05% or emedastine vehicle (placebo) in the contralateral eye. Efficacy was determined 10 minutes and 2 hours after administration of study medications. Ocular itching and redness scores were recorded 3, 5, and 10 minutes after conjunctival allergen challenge. RESULTS: A total of 97 subjects with a history of allergic conjunctivitis and a positive response to a diagnostic test were evaluable for safety analysis, and 91 subjects were evaluable for the efficacy analysis. Emadastine 0.05% was statistically significantly more effective than levocabastine 0.05% in reducing ocular itching after conjunctival allergen challenge in both the 10-minute and the 2-hour challenge (P <.05). Emedastine 0.05% and levocabastine 0.05% were statistically equivalent in reducing conjunctival redness after conjunctival allergen challenge, although emedastine tended to be more efficacious than levocabastine at every observation time point. CONCLUSIONS: After conjunctival allergen challenge, emadastine 0.05% is significantly more effective than levocabastine 0.05% in reducing ocular itching associated with allergic conjunctivitis. The two compounds are equivalent in controlling the conjunctival redness associated with allergic conjunctivitis.

Adolescent↗
PubMed1983

Trimethoprim-polymyxin B ophthalmic solution in the treatment of presumptive bacterial conjunctivitis--a multicentre trial of its efficacy versus neomycin-polymyxin B-gramicidin and chloramphenicol ophthalmic solutions.

Two-hundred and thirty patients with a diagnosis of presumptive bacterial conjunctivitis were assessed in a randomized double-blind multicentre trial. In two of the centres the patients had been treated with either trimethoprim-polymyxin B or neomycin-polymyxin B-gramicidin ophthalmic solution. In the other two centres the patients had been treated with either trimethoprim-polymyxin B or chloramphenicol ophthalmic solution. All of the preparations used were shown to be effective and very few adverse reactions were encountered. No significant difference in clinical efficacy could be demonstrated between trimethoprim-polymyxin B and neomycin-polymyxin B -gramicidin but trimethoprim-polymyxin B was found to be significantly better (P = 0.03) than chloramphenicol in reducing signs and symptoms.

Chloramphenicol↗
PubMed2002

Comparison of the clinical efficacy and tolerability of olopatadine hydrochloride 0.1% ophthalmic solution and loteprednol etabonate 0.2% ophthalmic suspension in the conjunctival allergen challenge model.

BACKGROUND: Olopatadine hydrochloride 0.1% ophthalmic solution and loteprednol etabonate 0.2% ophthalmic suspension are topical antiallergic agents indicated for treatment of the signs and symptoms of allergic conjunctivitis and seasonal allergic conjunctivitis (SAC), respectively. OBJECTIVE: The purpose of this study was to compare the efficacy and tolerability of olopatadine, loteprednol, and placebo in inhibiting the early-phase allergic reaction (within 30 minutes) after conjunctival allergen challenge (CAC). METHODS: This was a single-center, randomized, double-masked, parallel-controlled CAC study. It consisted of 3 visits, with CAC performed at visit 1, confirmation and randomization at visit 2, and evaluation of the treatments at visit 3. Subjects with a history of allergic conjunctivitis were randomized to receive olopatadine, loteprednol, or placebo in a 2:2:1 ratio. Because loteprednol requires a loading period to achieve maximum efficacy, subjects assigned to this treatment received loteprednol QID bilaterally for a 14-day period; the olopatadine and placebo groups received placebo QID bilaterally during this period. At the evaluation visit, subjects received 1 drop of the assigned treatment in each eye. Fifteen minutes later, they were challenged with allergen. Subjects evaluated itching at 3, 5, and 10 minutes after challenge using a standardized 5-point scale; the investigator evaluated redness at 10, 15, and 20 minutes after challenge. Intraocular pressure (IOP) was measured at baseline and after the 14-day loading period. Nonparametric analyses were performed on the change from visit 2 to visit 3 in mean itching and redness scores for each time point, and on the change in mean IOP from visit 1 to visit 3. RESULTS: Fifty subjects (86% white; 42% male, 58% female; age range, 21-71 years) were enrolled and completed the study (20 olopatadine, 20 loteprednol, 10 placebo). The allergens to which subjects reacted were ragweed pollen (40%), cat hair or dander (30%), grass pollen (24%), and tree pollen (6%). The difference in inhibition of itching and redness was clinically significant (> or =1 unit difference) and statistically significant (P < 0.05) in favor of olopatadine compared with loteprednol at all 3 time points. The loteprednol group had a statistically significant increase in IOP after 2 weeks of treatment (P < 0.001). CONCLUSION: In the population studied, olopatadine was more efficacious than loteprednol in reducing the acute signs and symptoms of SAC during the early phase of the ocular allergic reaction and appeared to be better tolerated.

Adult↗