Safety and efficacy of loteprednol etabonate for treatment of papillae in contact lens-associated giant papillary conjunctivitis.

Abstract:

:Loteprednol etabonate (LE) is a new corticosteroid based on the "soft drug" concept. Contact lens-associated giant papillary conjunctivitis (GPC) was studied as a model for the anti-inflammatory effect of LE. Patients with bilateral GPC were enrolled in a multicenter, randomized, double-masked, placebo-controlled, parallel group comparison of loteprednol etabonate 0.5% ophthalmic suspension and the LE vehicle (placebo). Patients were instructed to instill 1 drop of the test medication into each eye 4 times daily for 4 weeks, and follow-up examinations occurred on Days 2 or 3, 7, 14, 21, and 28 of masked therapy. Of 113 patients enrolled, 110 patients (LE = 55; placebo = 55) completed the study as planned. Patients receiving LE demonstrated significant reduction in the primary ocular signs of GPC (papillae, p < 0.001) and were rated better in the Investigator's Global Assessment (p = 0.017). LE did not elevate intraocular pressure during the study, and ratings for bulbar conjunctival injection and the Patient Opinion Assessment demonstrated statistical trends that favored treatment with LE. LE was well tolerated and was clinically effective for the treatment of GPC.

journal_name

Curr Eye Res

journal_title

Current eye research

authors

Bartlett JD,Howes JF,Ghormley NR,Amos JF,Laibovitz R,Horwitz B

doi

10.3109/02713689308999455

subject

Has Abstract

pub_date

1993-04-01 00:00:00

pages

313-21

issue

4

eissn

0271-3683

issn

1460-2202

journal_volume

12

pub_type

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