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

Author(s): Baudouin C, Nordmann JP, Denis P, Creuzot-Garcher C, Allaire C, Trinquand C

Affiliation(s): Hopital A. Pare, Boulogne-Billancourt, France. baudouin@quinze-vingts.fr

Publication date & source: 2002-11, Graefes Arch Clin Exp Ophthalmol., 240(11):929-35. Epub 2002 Oct 30.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

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.