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C Trinquand

Publications and source records attributed to C Trinquand.

At least 19 recordsLinked to original sources
PubMed2003

[Efficacy and safety of long-acting carteolol 1% once daily. A double-masked, randomized study].

PURPOSE: Carteolol is a beta-adrenoceptor antagonist with intrinsic sympathomimetic activity. Used topically to reduce intraocular pressure, it is typically applied twice daily. In an effort to provide a once-daily dosing regimen, carteolol was formulated with 1% alginic acid. Sodium alginate is a natural polymer product with bioadhesive properties providing increased corneal contact time and a better carteolol penetration through the cornea. The objective of this study was to evaluate the efficacy and safety of long-acting 1% carteolol alginate solution compared to standard 1% carteolol solution. METHODS: This was a double-masked, parallel group, multicentre study. Patients with ocular hypertension or open angle glaucoma (n=151) were randomly assigned to receive either 1% carteolol alginate once daily (AM) or standard 1% carteolol solution twice daily for 2 months. The masking was maintained through the use of a placebo in the evening for the alginate group. Entry into the study required unmedicated intraocular pressure (IOP) between 23 mmHg and 32 mmHg at 9 AM and 11 AM. Patients using ocular hypotensive medication were required to undergo a washout. All patients provided written informed consent. Excluded from the study were patients with angle closure, congenital, secondary glaucoma or advanced glaucoma; any intraocular infection or inflammation, ocular trauma, ocular surgery or laser trabeculoplasty within the previous 3 months; contraindications to the use of beta adrenoceptor antagonists; systemic medications likely to modify IOP prescribed or modified during the previous 3 months; ocular steroid use; contact lens wear; and pregnant and lactating women. Patients were evaluated at baseline, 15 and 60 days, with IOP measurements at 9 AM and 11 AM. At day 15 and day 60, IOP was measured just before instillation of medication (9 AM) and 2 hours after (11 AM). Slit lamp examinations were performed at each follow-up examination, together with measurement of heart rate and blood pressure (10 AM) and ocular tolerance after medication (11 AM). The primary efficacy criterion was the decrease in IOP from baseline at day 60 for each measurement at 9 AM and 11 AM. The study eye was the eye with the higher IOP at day 0 or, if equal, the right eye. RESULTS: Efficacy-of the 151 patients included in the study, 149 were evaluated (two patients were lost to follow-up after day 0): 74 in the alginate group and 75 in the standard group. Both treatment groups were comparable at day 0 except for sex, diastolic blood pressure, and IOP in the fellow eye. At 09.00 hours (presumed trough) on day 60, mean reductions from baseline in intraocular pressure were 6.32+/-2.87 and 5.67+/-3.30 mmHg for the alginate carteolol and standard groups, respectively. At 11.00 hours (presumed peak), mean reductions were 6.70+/-2.81 and 6.55+/-3.35 mmHg, respectively. At each evaluation time, the two unilateral t tests were highly significant (p<0.005), confirming the equivalence of both treatments. Conclusions were not modified taking into account sex and diastolic blood pressure. Safety- Slight decreases in heart rate and blood pressure means were observed in both groups at follow-up visits with no significant difference between groups. Subjective tolerance upon instillation was judged good or very good at day 60 by 100% of alginate patients and by 98.7% of standard patients. Transient discomfort (mainly stinging or burning sensation) was reported by approximately 4% - 6% of patients in each treatment group at each visit. A blurred vision sensation was reported by 2 out of 74 patients of the alginate group. Among the 17 reported adverse events, three were assessed as drug-related: one vertigo, one superficial punctate keratitis in the alginate group and one decrease in blood pressure in the standard group. No serious adverse events were reported. CONCLUSIONS: The new alginate formulation of long-acting carteolol 1% given once daily is as effective as standard 1% carteolol given twice daily, with no meaningful differences regarding safety. This efficacy wasy was verified at 9 AM (24 hours after the last drop of long-acting carteolol or 12 hours after that of standard carteolol) and at 11 AM (2 hours after the morning drop). The new alginate formulation of long-acting carteolol 1% given once a day is effective and well tolerated by glaucoma patients who require chronic treatment.

Adrenergic beta-Antagonists↗
PubMed2002

Alginic acid effect on carteolol ocular pharmacokinetics in the pigmented rabbit.

The effect of alginic acid addition to 1% or 2% carteolol solutions on the ocular penetration of the drug has been evaluated in the pigmented rabbit. During single dose studies, an increase in bioavailability ranging from 40% to 60% was observed in the aqueous humor and in the iris-ciliary body. During repeated dose studies, this increased ocular bioavailability of carteolol in the presence of alginic acid led to an equivalent concentration in the target tissue, although the dosage was only once a day compared with twice a day for the usual carteolol eyedrops. 14C-carteolol distribution studies demonstrated the binding of carteolol in pigmented ocular tissues. Thus, the presence of alginic acid as a new excipient supports a possible decrease in dosage regimen, while retaining sufficient ocular bioavailability to lower intraocular pressure.

Adrenergic beta-Antagonists↗
PubMed2001

Ocular hypotensive efficacy and safety of once daily carteolol alginate.

BACKGROUND/AIM: Carteolol is a beta adrenoceptor antagonist used topically to reduce intraocular pressure, typically twice daily. In an effort to provide a once daily dosing regimen, carteolol was formulated with 1% alginic acid. The objective of this study was to evaluate the efficacy and safety of carteolol alginate solution in comparison with standard carteolol solution. METHODS: This was a double masked, parallel group, multicentre study. Patients with ocular hypertension or open angle glaucoma (n=235) were randomly assigned to receive either carteolol alginate once daily [corrected] or standard carteolol solution, twice daily. The masking was maintained through the use of a vehicle in the evening for the alginate group. Patients were evaluated at baseline, 15, 60, and 120 days. RESULTS: At 0900 (presumed trough) on day 60, mean reductions in intraocular pressure (IOP) from baseline were 6.09 (SD 2.97) and 6.09 (3.18) mm Hg for the standard carteolol and alginate, respectively. At 1100 (presumed peak), mean reductions were 6.51 (2.53) and 6.47 (2.76) mm Hg, respectively. Results were similar at other times (day 15 and day 120). The most common side effect was transient stinging on instillation of drops, which did not differ significantly between groups. There were no differences of note in other ocular or systemic signs or symptoms. CONCLUSION: The new alginate formulation of carteolol 2% given once daily was as effective as standard carteolol 2% given twice daily with no meaningful differences regarding safety.

Adolescent↗
PubMed2000

A new long acting ophthalmic formulation of carteolol containing alginic acid.

Alginic acid was evaluated as a potential vehicle in ophthalmic solutions for prolonging the therapeutic effect of carteolol. This anionic vehicle was expected to slow down drug elimination by the lacrimal flow, both by undergoing in-situ gel formation and by interacting with the mucus. In vitro studies indicated that carteolol is released slowly from alginic acid formulations, suggesting an ionic interaction. The adhesive behavior of alginic acid solution was better than that of another polymer, hydroxyethylcellulose (HEC). Intraocular pressure (IOP) measurements of rabbit eyes treated with a 1% carteolol formulation with or without alginic acid showed that this polymer significantly extended the duration of the pressure-reducing effect of carteolol to 8 h. The increased ocular bioavailability of 1% carteolol in the presence of alginic acid led to an equivalent concentration in the target tissue although administration was only once a day compared with twice a day for 1% carteolol alone. The overall results of this study indicate that the alginic-acid vehicle is an excellent drug carrier, well tolerated, and could be used for the development of a long-acting ophthalmic formulation of carteolol.

Adhesiveness↗
PubMed2000

[Ocular drug penetration].

The study of ocular drug penetration may take into account many factors connected to the ophthalmic route specificity: anatomical barriers of the eye, solubility, molecular weight and eyedrops concentration. The factors influencing ocular drug penetration are reviewed. The broad outlines of research focuses now on an increase of the bioavailability, a best tolerability and a reduction of systemic effects of drugs.

Biological Availability↗
PubMed1999

Topical indomethacin solution versus dexamethasone solution for treatment of inflamed pterygium and pinguecula: a prospective randomized clinical study.

PURPOSE: To compare the effect of topical indomethacin 0.1% solution with the effect of topical dexamethasone 0.1% phosphate solution on signs and symptoms of inflamed pterygium and pinguecula. METHODS: Of 50 consecutive patients who had inflamed pterygia (n = 17) or pingueculae (n = 33), met the study criteria, and signed an informed consent, one eye of each patient was evaluated in a comparative, prospective, randomized, double-masked, controlled study. Objective signs (conjunctival congestion, redness and edema, and staining of cornea) and subjective complaints (photophobia, pain, foreign-body sensation, discomfort, and tearing) were evaluated and scored. We also evaluated "total signs," "total symptoms," and "total score." Group 1 (n = 25) received topical indomethacin 0.1% solution, and group 2 (n = 25) received a topical dexamethasone phosphate 0.1% solution six times daily for 3 days, then four times daily over the following 11 days. Patients were examined before treatment, on days 3, 7, and 14 after the treatment was initiated, and 2 and 4 weeks after the treatment was discontinued. RESULTS: In both groups, the scores for "total signs," "total symptoms," and "total score" were significantly lower (P = .001) by day 14. There were no differences between groups 1 and 2 for "total signs," "total symptoms," and "total score" at days 3, 7, and 14 (P = .07 to P = .88). After treatment was discontinued, the dexamethasone-treated group experienced a significantly greater recurrence of "total signs" (P = .023 at day 30, P = .02 at day 45), but there was no statistically significant difference in "total symptoms" and "total score." Patients in group 2 reported more stinging after drops were administered than patients in group 1 (P = .002). CONCLUSIONS: This study indicates that topical indomethacin 0.1% solution is as effective as topical dexamethasone phosphate 0.1% solution for the treatment of inflamed pterygium and pinguecula and, therefore, is suggested as an effective treatment for these conditions.

Administration, Topical↗
PubMed1998

Comparison of the efficacy and safety of two eye gels in the treatment of dry eyes: Lacrinorm and Viscotears.

PURPOSE: To compare the efficacy and safety of two carbomer 940 eye gels in the treatment of dry eyes: Lacrinorm (also called GelTears), a recently introduced eye gel, and Viscotears (also called Vidisic or Lacrigel), used as a reference gel. The main difference between the two gels is in the preservative, respectively benzalkonium chloride and cetrimide. METHODS: A double-masked, randomised, parallel-group study was conducted in 16 centres in four European countries. A total of 179 patients suffering from aqueous-deficient dry eye were enrolled, of whom 92 were randomised to treatment with Lacrinorm and 87 to the reference gel. Gel was instilled four times a day for a period of 30 days. RESULTS: After 30 days of treatment, subjective symptoms (the combined scores of foreign body sensation, ocular dryness, burning or pain, and photophobia) had improved by 50% in the Lacrinorm group and by 45% in the reference gel group, and objective test results (break-up time, fluorescein test, Schirmer test, Lissamine Green test) by 35-36% in the Lacrinorm group and 25-45% in the reference group. The improvements were significant in both treatment groups (p < 0.001), with no significant differences between the treatment groups. Subjective local tolerability upon instillation on day 30 was rated 'good' or 'very good' by 91% of patients in both treatment groups. Adverse events were reported for 21 patients in the Lacrinorm group and 17 in the reference group, the most frequent being discomfort, blurred vision, hyperaemia, burning and itching. The frequency and descriptions of adverse events did not differ significantly between the two treatment groups. No serious adverse events were reported. CONCLUSIONS: Over the period of study, Lacrinorm eye gel was as effective and safe as Viscotears/Lacrigel in the treatment of dry eye.

Acrylic Resins↗
PubMed1998

[Value of the conjunctival provocation test in evaluating the activity of 2 concentrations of anti-allergy eyedrops, mequitazine].

PURPOSE: To compare the activity of topical 0.05% and 0.01% mequitazine versus vehicle in the prevention of allergic conjunctivitis induced by a conjunctival provocation test with allergens. METHODS: Forty subjects with a history of grass pollen allergic conjunctivitis were enrolled in this comparative, randomized, double-masked study. Fifteen minutes before the conjunctival provocation test, subjects received one instillation alone of 0.05% mequitazine eyedrops in one eye and in the fellow eye either one drop of 0.01% dose or vehicle, at the same dosage. Then a specific conjunctival provocation test (CPT) was performed with the allergen threshold concentration previously defined. The therapeutic efficacy was assessed by the decrease in a symptomatic composite score representing the allergic reaction. RESULTS: Topical mequitazine at the dose of 0.05% significantly decreases the intensity of the allergic reaction compared to vehicle. Moreover, the group treated with this dose needed a higher allergen concentration to trigger ocular signs. The 0.01% dose appears efficient only on itching, compared to vehicle. CONCLUSION: The results of this study support the efficacy and the onset of action of 0.05% mequitazine eyedrops versus 0.01% or vehicle in the prevention of allergic conjunctivitis induced by a conjunctival provocation test.

Adult↗
PubMed1997

Efficacy of mequitazine in comparison with placebo assessed by ocular challenge with allergen in allergic conjunctivitis.

Pharmacologic intervention in the management of allergic conjunctivitis was evaluated with different topical ocular agents in man. Their effect can be precisely assessed with the conjunctival provocation test (CPT). A potent specific H1-receptor antagonist, 0.05% mequitazine eye-drops, was tested in a double-blind randomized, placebo-controlled study using CPT with grass pollen allergens. Twenty healthy subjects allergic to grass pollen were included outside the pollen season after a positive CPT screening. They received one drop of 0.05% mequitazine in one eye and the vehicle in the contralateral eye in a random order, four times daily for 5 days. CPT was performed 15 min after the last instillation, and the threshold dose inducing a positive reaction was determined. Results were given by Abelson's composite score including redness, chemosis, tearing, and itching. Topical 0.05% mequitazine significantly reduced the composite score compared to placebo. The allergen threshold concentration which induced the positive conjunctival reaction was higher in mequitazine pretreated eyes. No side-effect was reported. These data clearly suggest that mequitazine has potential to treat allergic conjunctivitis.

Adult↗
PubMed1997

Treatment of inflamed pterygium and pinguecula with topical indomethacin 0.1% solution.

PURPOSE: To evaluate the effect of topical indomethacin 0.1% on signs and symptoms in inflamed pterygium and pinguecula. METHODS: Fifty-one consecutive patients who had inflamed pterygium (n = 32) or pinguecula (n = 19) were studied in a randomized, double-masked, controlled way. Objective signs (conjunctival congestion, redness, edema, and staining of cornea) and subjective complaints (photophobia, pain, foreign-body sensation, discomfort, and tearing) were evaluated and scored. In addition, we evaluated total signs, total symptoms, and total score. Group 1 (n = 25) received topical indomethacin 0.1% solution and group 2 (n = 26) received a placebo six times daily for 3 days, then four times daily for 11 days. Patients were examined before and at days 3, 7, and 14 after the treatment began. RESULTS: In group 1 at day 3, the scores of total signs, total symptoms, and total score decreased (p = 0.001), and they further decreased after 14 days (p = 0.02 to p = 0.05). In group 2 at day 3 these parameters also significantly decreased (p = 0.01 to p = 0.02), but no further improvement occurred after 14 days. Comparing groups 1 and 2 revealed a decrease in scores in group 1 for total signs, total symptoms, and total score at days 3, 7, and 14 (p = 0.03 to p = 0.002) except for total signs after 14 days (p = NS). All the patients reported mild stinging for < 1 min after administration of the drops. CONCLUSIONS: This study indicates that topical indomethacin solution 0.1% is a useful treatment for inflamed pterygium and pinguecula.

Administration, Topical↗
PubMed1997

[Double-blind study on 3 parallel groups of 2 formulations of 0.1% indomethacin and 0.1% diclofenac in preventing and controlling inflammation after cataract surgery].

PURPOSE: To evaluate the efficiency and safety of LCM 1110 eyedrops, a new 0.1% indomethacin formulation, compared with the registered 0.1% indomethacin solution and with 0.1% diclofenac, in the management of post cataract surgery inflammation. METHODS: A total of 352 patients randomly assigned to LCM 1110 (n = 116), to indomethacin (n = 121) or to diclofenac (n = 115) were included in this three-arm, prospective, multicenter and double-masked trial, after giving written informed consent. They were given preoperatively 1 drop QID the day before surgery, 5 drops within 2 hours prior to operation then 1 drop QID for 1 month. Cataracts were extracted by either extracapsular or phacoemulsification methods, with PC-IOL implantation. The main efficacy evaluation was based on the assessments of anterior chamber cells and flare at days 1, 7 and 30 following surgery. Symptoms, other objective signs and IOP were recorded. RESULTS: Cellular and proteinic Tyndall phenomenon did not significantly differ in the 3 groups, at any of the post surgical assessments. Clinical symptoms and visual acuity improved similarly. IOP was not adversely affected by any drug. Compared with subjects having received LCM 1110, diclofenac-treated patients experienced a superficial punctuate keratitis more frequently. Tolerance of instillation, measured by a visual analogic scale, was best improved by LCM 1110 followed by the indomethacin solution and by diclofenac (LCM 1110-diclofenac; p = 0.004). CONCLUSION: These data suggest that LCM 1110, a new 0.1% indomethacin ophthalmic solution, appears to be a safe promising agent for the control of postoperative inflammation.

Aged↗
PubMed1997

Comparative study of two non-steroidal anti-inflammatory eyedrops, 0.1% indomethacin versus 0.1% diclofenac in pain control post photorefractive keratectomy.

We evaluated the efficacy and safety of 0.1% indomethacin and 0.1% diclofenac solutions, in controlling pain post excimer laser photorefractive keratectomy (PRK). After written consent, 61 informed patients (23 males, 38 females; mean age = 33.5 +/- 8.4 yrs) were enrolled in a double-masked, randomized, comparative study and assigned to either indomethacin or diclofenac treatment. Subjective preoperative evaluation of individual susceptibility to pain evoked by topical application of 1% tetracaine vs saline served as reference for further post-operative pain measurement using a visual analog rating scale. Ocular and cephalic pain, itching, foreign body sensation, insomnia, photophobia, blepharospasm as well as systemic analgesic medication and alcohol intake were monitored for 3 days following photoablation as well as the re-epithelialization process. Both solutions significantly reduced pain on the first day following excimer laser PRK, and this activity was maintained until the end of the observation period. At Day 0 the first measure of pain level was slightly higher in the indomethacin group (p < 0.05) and could be related to a possible anaesthetic effect of Diclofenac. During the follow-up the oral intake of analgesics was higher in the diclofenac group, however this difference was not significant. Wound healing rate was not affected by indomethacin or diclofenac administration. These data suggest that both 0.1% indomethacin and 0.1% diclofenac ophthalmic solutions may help to control the pain induced by excimer laser PRK without any deleterious effect on corneal wound healing.

Adult↗
PubMed1996

[Efficacy and tolerability of a combination of indomethacin and gentamicin for preventing inflammation after cataract surgery].

PURPOSE: The aim of the study was to compare 2 combinations of anti-inflammatory drug and antibiotic, in patients undergoing cataract surgery: 0.1% indomethacin/gentamicin or 0.1% dexamethasone/ neomycin. METHODS: Two hundred and two patients undergoing extra-capsular cataract extraction with posterior chamber lens implantation were included in a randomized, double-blinded multicentric study comparing 2 parallel groups of treatment. Treatment was administered the day before surgery, the day of surgery and for the following 7 days. On the 8th post-operative day, the antibiotic was stopped and the anti-inflammatory treatment continued alone until the 30th post-operative day. Post-operative ocular inflammation was assessed clinically on the 1st, 7th, 15th and 30th post-operative days. The main evaluation criterion of treatment efficacy was the assessment of anterior chamber flare and cells. RESULTS: No statistically significant difference-was observed between the 2 treatment groups concerning post-operative inflammation. Both treatments were well tolerated. CONCLUSION: Eye drops combining 0.1% indomethacin and gentamicin proved to be effective and well tolerated in preventing inflammation after cataract surgery.

Adult↗
PubMed1995

[Comparative prospective study of effects of Biovisc and Healonid on endothelial cell loss and intraocular pressure in cataract surgery].

PURPOSE: The goal of this trial was to evaluate the efficacy (protective action on corneal endothelium and ability to facilitate the procedure) as well as safety (effect on intraocular pressure and inflammation) of Biovisc (new viscoelastic agent made of 1% sodium hyaluronate produced by bacterial fermentation) versus Healonid) postcataract surgery (manual or phacoemulsification). METHODS: 106 patients, 45 males and 61 females (31-94 years) were included in this prospective randomized multicentre trial and followed up for three months. Specular microscopy and intraocular pressure (IOP) measurement were the main evaluation criteria. RESULTS: At D 90, no significant difference was observed between the two viscoelastic agents on the mean endothelial cell loss (group Viovis: -8.6%; group Healonid: -6%) as well as on IOP (early peaks were transitory and resolutive). CONCLUSION: Biovisc and Healonid were similar in terms of efficacy and tolerance.

Adult↗
PubMed1995

[Hypotensive action of 0.5% carteolol versus 0.1% timolol in patients with intraocular hypertension].

PURPOSE: The aim of the study was to compare 2 beta-blocker eye drops at a low concentration: 0.5% carteolol and 0.1% timolol. METHODS: The study was designed as a random-order, double-blinded comparison of 2 parallel treatment groups. Fifty patients with early primary open angle glaucoma or high intraocular pressure were included. The treatment lasted 4 weeks, on the basis of 1 drop twice daily. Diurnal I.O.P. curve was assessed with 4 measurements from 8.30 a.m. to 4.30 p.m. before and after treatment. The 8.30 a.m. measure of the final assessment of I.O.P. curve was established prior to morning medication. The mean values of the 4 measures were compared. RESULTS: Both treatments reduced IOP by a comparable amount: 4.25 +/- 1.2 mmHg (mean +/- SD) for carteolol and 4.69 +/- 1.9 mmHg for timolol. The decrease of IOP was found at every time of assessment, without any significant difference between treatments. Both eye drops were very well tolerated. CONCLUSION: The results of this study show that the new beta-blocker eye drop solution 0.5% carteolol is effective for initial management of high intraocular pressure.

Adult↗
PubMed1994

[Comparative efficacy of 0.1% indomethacin eyedrops, 0.03% flurbiprofen eyedrops and placebo for maintaining peroperative mydriasis].

A randomized, double-blind study was conducted to compare the effect of 0.1% indomethacin solution versus 0.03% flurbiprofen versus placebo on the maintenance of mydriasis during cataract surgery. Ninety-five patients undergoing extracapsular cataract extraction with posterior chamber lens implantation were enrolled. Pupillary diameters were measured horizontally under operating-microscope visualization before 5 surgical steps: 1. corneo-scleral incision; 2. lens nucleus expression; 3. lens cortex material aspiration; 4. intra-ocular lens implantation; 5. end of surgery. The mydriasis loss during surgery was statistically less in the 2 groups treated by non steroidal anti-inflammatory drugs than in the placebo group. This effectiveness appeared at the time of lens nucleus expression (p = 0.0001) and persisted until the end of surgery. Then, the mydriasis was maintained during 2 crucial surgical steps requiring optimal pupillary dilation: lens cortex material aspiration and intra-ocular lens implantation. No significant difference was found between 0.1% indomethacin and 0.03% flurbiprofen concerning effectiveness and tolerance.

Adult↗