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At least 19 recordsLinked to original sources

A randomized, comparative study of fluorometholone 0.2% and fluorometholone 0.1% acetate after photorefractive keratectomy.

PURPOSE: To compare the efficacy and tolerance of fluorometholone 0.1% acetate and fluorometholone 0.2% eyedrops in the postoperative management of photorefractive keratectomy (PRK). METHODS: A randomised single-blind comparative study was performed on two groups of 30 patients who underwent myopic PRK. The first group was given fluorometholone 0.1% acetate and the second fluorometholone 0.2%. Uncorrected and best corrected visual acuity, haze, IOP and local tolerance were evaluated. Statistical analysis was done using parametric and non-parametric tests. RESULTS: Visual acuity did not differ in the two groups; both were homogeneous as far as refractive error and haze were concerned. Three patients (10%) treated with fluorometholone 0.2% and two patients (6.6%) with fluorometholone 0.1% acetate developed ocular hypertension, but this was not statistically significant. CONCLUSIONS: Fluorometholone 0.1% acetate was effective on inflammation after PRK, with the same efficacy as fluorometholone 0.2%.

Administration, Topical↗

Fluorometholone acetate. A new ophthalmic derivative of fluorometholone.

Hourly topical administration of 0.1% fluorometholone acetate ophthalmic suspension produced, on the average, a 47% reduction in the polymorphonuclear leukocytes invading the cornea during an experimentally induced inflammatory keratitis. This is a significantly greater anti-inflammatory effect than we have previously reported for the alcohol derivative of fluorometholone and is not significantly different from the therapeutic effect of 1.0% prednisolone acetate ophthalmic suspension, the most effective corneal anti-inflammatory agent that we have studied to date. Fluorometholone acetate (0.1%) formulated as a high-viscosity carbomer gel and applied at three-hour intervals reduced invading leukocytes in the cornea an average of 48%, an effect not significantly different from hourly administration of the suspension.

Acetates↗

Intraocular pressure response to topically administered fluorometholone.

Certain corticosteroids, including fluorometholone, have been reported to have a low propensity for elevating intraocular pressure. Our clinical impression was that the incidence of IOP increase with fluorometholone may be higher than reported. This study was to determine the incidence and degree of IOP response to 0.1% fluorometholone suspension in 43 patients demonstrated to be responsive to 0.1% dexamethasone sodium phosphate solution. Twenty-six patients (60.5%) had IOP increases of 5 mm Hg or more while receiving fluorometholone, and three patients (7%) demonstrated pressure rises greater than 15 mm Hg. Fluorometholone can significantly raise IOP in a significant number of corticosteroid responders.

Administration, Topical↗

The ocular hypertensive effect of 0.25% fluorometholone in corticosteroid responders.

Fourteen subjects known to be corticosteroid responders participated in a double-masked, randomized study comparing the ocular hypertensive effect of 0.25% fluorometholone suspension with that of 0.1% dexamethasone sodium phosphate. Subjects instilled one drop of fluorometholone in one eye and one drop of dexamethasone in the fellow eye four times daily for up to six weeks. Although both medications increased intraocular pressure, endpoint substitution analysis demonstrated that mean intraocular pressure increases from baseline in the eyes treated with fluorometholone were significantly lower than those in the eyes treated with dexamethasone at weeks 2, 4, and 6 (P less than or equal to .05). Also, mean maximum intraocular pressure was significantly lower in the eyes treated with fluorometholone than in the eyes treated with dexamethasone (P = .001). These results indicated that 0.25% fluorometholone is less likely to increase intraocular pressure in corticosteroid responders than 0.1% dexamethasone.

Adrenal Cortex Hormones↗

Effect of topical anti-inflammatory treatment on the outcome of laser trabeculoplasty. The Fluorometholone-Laser Trabeculoplasty Study Group.

PURPOSE: We investigated the effect of anti-inflammatory treatment on the outcome of argon laser trabeculoplasty. METHODS: In this multicenter, double-masked, randomized, placebo-controlled, parallel comparison study, 140 chronic open-angle glaucoma patients received either 0.25% fluorometholone or vehicle four times a day unilaterally, beginning 24 hours before and continuing one week after argon laser trabeculoplasty. The laser surgeon placed 50 to 60 burns over the inferior 180 degrees of the trabecular meshwork. The patients were followed up frequently for five weeks after the procedure. RESULTS: Following argon laser trabeculoplasty, signs of anterior chamber inflammation were significantly lower in the fluorometholone group. However, there was no significant difference between the fluorometholone and the vehicle groups in the incidence of increased intraocular pressure in the immediate post-argon laser trabeculoplasty period. Intraocular pressure decreased significantly in both groups from day 1 throughout the follow-up period. A significant between-group difference in intraocular pressure decrease was found only at week 5 (7.83 +/- 6.27 [S.D.] mm Hg for the fluorometholone group vs 6.63 +/- 5.79 mm Hg for the vehicle group, P = .046). No drug-related clinically significant adverse events were observed. CONCLUSIONS: Use of fluorometholone is effective in attenuating inflammation and has no clinically significant impact on the outcome of argon laser trabeculoplasty or on the incidence of intraocular pressure spikes during the immediate post-argon laser trabeculoplasty period.

Administration, Topical↗

Effect of topical anti-inflammatory treatment on the long-term outcome of laser trabeculoplasty. Fluorometholone-Laser Trabeculoplasty Study Group.

PURPOSE: To investigate the effect of anti-inflammatory treatment on the long-term outcome of argon laser trabeculoplasty, we extended the short-term study of the Fluorometholone-Laser Trabeculoplasty Study Group. METHODS: Among the chronic open-angle glaucoma patients randomly assigned to the 0.25% fluorometholone or placebo eyedrops four times daily before and after argon laser trabeculoplasty in the Fluorometholone-Laser Trabeculoplasty Study, the long-term records of 27 patients (13 eyes in the fluorometholone group and 14 eyes in the placebo group) were available for our review and analysis. RESULTS: There were no statistically significant differences in the success rate of argon laser trabeculoplasty between the fluorometholone and control groups over the follow-up period of 4.6 +/- 3.4 years. CONCLUSION: While it decreased ocular inflammation and discomfort during the early postoperative period, peri-argon laser trabeculoplasty use of a topical corticosteroid did not influence the long-term intraocular pressure outcome of argon laser trabeculoplasty.

Administration, Topical↗

Effects of lodoxamide, disodium cromoglycate and fluorometholone on tear leukotriene levels in vernal keratoconjunctivitis.

PURPOSE: We compared tear leukotriene B4 (LTB4) and leukotriene C4 (LTC4) levels of vernal keratoconjunctivitis (VKC) patients with those of age-matched controls and evaluated the effects of disodium cromoglycate (DCG) 2%, lodoxamide 0.1% and fluorometholone 0.1% on the tear LTB4 and LTC4 levels of the VKC patients. METHODS: Thirty VKC patients were divided into three groups and their tear LTB4 and LTC4 levels measured with an enzyme-linked immunoassay technique before and after treatment with either lodoxamide 0.1%, DCG 2% or fluorometholone 0.1%. The results were compared with the tear LTB4 and LTC4 levels of 10 healthy control subjects. During this trial period, clinical scores for signs and symptoms of VKC were also evaluated. RESULTS: In the VKC patients median tear LTB4 and LTC4 levels were 349.0 pg/ml (range 213.3-707.7 pg/ml) and 225.2 pg/ml (range 196.1-241.1 pg/ml) respectively--significantly higher than the control group (p = 0.0065 for LTB4 and p = 0.0003 for LTC4). After treatment, LTB4 levels decreased significantly in all treatment groups when compared with baseline (for the lodoxamide group, p = 0.01; for the DCG group, p = 0.008; for the fluorometholone group, p = 0.045). LTC4 levels were also significantly reduced after treatment in all three treatment groups (for the lodoxamide group, p = 0.0209; for the DCG group, p = 0.0284; for the fluorometholone group, p = 0.0109). CONCLUSIONS: Tear LTB4 and LTC4 levels are significantly higher in VKC patients than controls, which points to a possible role of lipoxygenase pathway products in the pathophysiology of ocular allergic disorders. Lodoxamide 0.1%, DCG 2% and fluorometholone 0.1% were all effective in reducing LTB4 and LTC4 levels in VKC.

Adolescent↗

Efficacy of nedocromil 2% versus fluorometholone 0.1%: a randomised, double masked trial comparing the effects on severe vernal keratoconjunctivitis.

AIMS: To compare the efficacy of topical nedocromil 2% with fluorometholone 0.1% in vernal keratoconjunctivitis (VKC). METHODS: In a double masked random design, 24 patients with severe vernal keratoconjunctivitis were placed at random on nedocromil 2% eye drops in one eye and fluorometholone 0.1% in the fellow eye. At the end of the 2 week treatment period, the patient crossed over the eye drops (if asymptomatic in one eye), or continued with nedocromil sodium in both eyes (if asymptomatic in both eyes). All patients were examined weekly and ocular surface temperature recorded for a period of 6 weeks. RESULTS: Improvement in the watering, discharge, conjunctival hyperaemia, papillary hypertrophy, and Trantas' dots was noted in both groups, but overall fluorometholone was significantly more effective than nedocromil. Eyes treated with fluorometholone showed a significant decrease in ocular surface temperature compared with nedocromil treated eyes (p = 0.03). CONCLUSIONS: Both nedocromil and fluorometholone were effective in ameliorating the signs and symptoms of vernal keratoconjunctivitis. No adverse effects were noted in the nedocromil group.

Adolescent↗

Ocular anti-inflammatory and systemic immunosuppressive effects of topically applied fluorometholone.

Anti-inflammatory and systemic immunosuppressive effects of topically applied steroidal and nonsteroidal anti-inflammatory agents on experimental immunogenic uveitiis in rabbits were studied. The onset of the immunogenic uveitis induced by a single intravitreous injection of bovine serum albumin (BSA) was significantly correlated with the appearance of anti-BSA antibody in the serum. A significant correlation was also found between the maximum serum level of antibody and the maximum severity of uveitis. Suspensions of fluorometholone, dexamethasone or indomethacin were applied topically twice a day for a month to eyes injected with BSA. Ocular inflammation was suppressed by fluorometholone and dexamethasone, fluorometholone having the greater anti-inflammatory activity. The circulating antibody titer was also suppressed by both these steroids, but conversely fluorometholone had the lower systemic immunosuppressive activity. Indomethacin did not suppress the uveitis or circulating antibody production. The results of these investigations indicate that the anti-inflammatory effect of the steroid fluorometholone surpasses the immunosuppressive effect, unlike usual anti-inflammatory steroids.

Administration, Topical↗

Fluorometholone acetate: clinical evaluation in the treatment of external ocular inflammation.

Separate, randomized, double-masked clinical studies were conducted to determine the therapeutic efficacy of fluorometholone acetate, a new ophthalmic corticosteroid formulation, in suppressing external ocular inflammation (conjunctivitis, episcleritis, scleritis). Fluorometholone acetate 0.1% was compared to fluorometholone 0.1%, and the acetate formulation was found to be significantly (p = 0.03) more effective. Fluorometholone acetate 0.1% also was compared to prednisolone acetate 1.0%; there was no significant difference (p = 0.49) between these two corticosteroids in their ability to suppress external ocular inflammation. It appears that alteration of fluorometholone from its alcohol base to its acetate derivative changes the drug from a moderately effective to a highly effective anti-inflammatory agent.

Adult↗

Efficacy of indomethacin 0.1% and fluorometholone 0.1% on conjunctival inflammation following chronic application of antiglaucomatous drugs.

BACKGROUND: Subclinical conjunctival inflammation has been shown to have a deleterious effect on the outcome of filtering surgery. The study was designed to assess the efficacy and safety of a non-steroidal anti-inflammatory ophthalmic solution (preservative-free indomethacin 0.1%) on conjunctival inflammation following chronic application of antiglaucomatous drugs, in comparison with a steroidal ophthalmic solution (preserved fluorometholone). METHODS: Eighty-nine glaucomatous patients were included in a randomised, multicentre study comparing two parallel groups of treatment given on the basis of 1 drop 4 times daily for 1 month before filtering surgery. Patients had been treated with one or more antiglaucomatous drugs for at least 3 years. The routine antiglaucomatous treatment was continued during the study. Evaluations were carried out at baseline and after 30 days of treatment. Conjunctival inflammation was assessed under masked conditions by means of conjunctival impression analysis which determined the percentage of cells expressing HLA-DR. The ocular surface was also examined using the fluorescein test and lissamine green staining. RESULTS: Paired conjunctival impression specimens available both on day 0 (D0) and day 30 (D30) involved 49 patients. Among them, 34 eyes had a positive expression of HLA-DR at inclusion. On D30, in patients positive to HLA-DR on D0, the percentage of cells expressing HLA-DR had significantly decreased in both treatment groups: the mean reduction was 29.7% from a baseline value of 51.4% in the indomethacin group ( P=0.019) and 32.5% from a baseline value of 48.7% in the fluorometholone group ( P<0.001). There was no significant difference between groups. Seven cases of drug-related superficial punctate keratitis were observed on D30 by means of a fluorescein test: one in the indomethacin group and six in the fluorometholone group. CONCLUSION: Both anti-inflammatory eyedrops were effective in reducing subclinical conjunctival inflammation before filtering surgery. Regarding superficial punctate keratitis, the corneal tolerance of preservative-free indomethacin 0.1% eyedrops seemed to be better than that of preserved fluorometholone eyedrops.

Aged↗

Comparative study of the intraocular pressure effects of fluorometholone 0.1% versus dexamethasone 0.1%.

The intraocular pressure effect of fluorometholone 0.1% was compared with that of dexamethasone 0.1% by performing corticosteroid provocative tests on 24 matched pairs of eyes. Fifteen of the 24 dexamethasone treated eyes, 62.5%, showed a change in intraocular pressure greater than 5 mmHg, with mean delta P = 8.58 mmHg and range 0 to +20 mmHg. Only 2 of the 24 fluorometholone treated eyes, 8.3%, showed a change in pressure greater than 5 mmHg, with mean delta P = 2.96 mmHg and range -2 to +14 mmHg. There was a highly statistically significant difference between the intraocular pressure effects of topical dexamethasone and fluorometholone (correlated t test, p less than 0.001). Fluorometholone would appear to be the topical steroid of choice for patients with glaucoma and other known steroid responders when topical steroid treatment is indicated.

Dexamethasone↗

[Fluorometholone Reference Standard (control 011) of National Institute of Health Sciences].

The raw material of fluorometholone was examined for the preparation of the "Fluorometholone Reference Standard (Control 011)". The analytical data obtained were: optical rotation, [alpha]20D = .5 degrees; UV spectrum, lambda max of 240 nm and specific absorbance in methanol at 240 nm = 350.7; IR spectrum, same as that of the Fluorometholone Reference Standard (Control 864); high-performance liquid chromatography (HPLC), total amount of impurities estimated to be less than 0.5%; loss on drying, 0.01%. Based on the above results, the raw material was authorized as the Fluorometholone Reference Standard (Control 011) of the National Institute of Health Sciences.

Chemical Phenomena↗

Therapeutic effectiveness of fluorometholone in inflammatory keratitis.

During an experimentally-induced inflammatory keratitis, we measured the ability of 0.1% fluorometholone ophthalmic suspension to reduce the numbers of polymorphonuclear leukocytes that invaded the cornea. The data demonstrate that topically administered fluorometholone is an effective therapeutic agent and that it compares favorably in anti-inflammatory activity with dexamethasone and prednisolone preparations. Comparison of our results with comparable studies of dexamethasone and prednisolone formulations indicates that 1.0% prednisolone acetate ophthalmic suspension is still the most effective corneal anti-inflammatory agent that we have investigated to date. However, the decreased potential of fluorometholone to produce secondary elevation of the intraocular pressure would appear to make it the drug of choice in situations in which maximum pharmacologic suppression of inflammation is not required and in chronic inflammatory conditions that require prolonged treatment.

Administration, Topical↗

Effect of topical 0.1% indomethacin solution versus 0.1% fluorometholon acetate on ocular surface and pain control following laser subepithelial keratomileusis (LASEK).

PURPOSE: To compare the effect of topical 0.1% indomethacin solution versus 0.1% fluorometholon acetate in the early postoperative period after LASEK treatment. METHODS: One hundred thirty-five patients undergoing LASEK, having been randomized in a double-masked manner into 2 groups (1 receiving indomethacin and 1 fluorometholon), were evaluated 2-4 days before and 4 days after treatment. We examined corneal fluorescein staining and corneal esthesiometry; the level of pain experienced was reported by the patient on a visual pain scale. In addition, haze was evaluated at 14 +/- 1 weeks after surgery. RESULTS: The pain level and corneal fluorescein staining were significantly less in the indomethacin group. Corneal esthesiometry was reduced to the same extent in the 2 groups. There were no statistically significant differences in haze presentation between the 2 groups. CONCLUSION: Our study highlights the efficacy of indomethacin solution compared with fluorometholon as a pain reducer after LASEK treatment and suggests that indomethacin is associated with a faster epithelial healing process.

Administration, Topical↗

Effect of fluorometholone (FML) on the intraocular pressure of corticosteroid responders.

Steroid responsiveness to dexamethasone was determined in a large family with an established dominant form of chronic simple glaucoma. The high and intermediate steroid responders were then tested with fluorometholone--a steroid which is claimed to have a reduced risk of increasing intraocular pressure. It was found that fluorometholone had a much less pronounced ocular hypertensive effect than dexamethasone. However, one patient showed a comparable response on both drugs, and this suggests that some caution must still be exercised when using the drug on susceptible individuals. Fluorometholone was also found to be more irritable to the eye than dexamethasone.

Dexamethasone↗