drugset / Trial / NCT04376970

Treatment of Corneal Infiltrates Secondary to Epidemic Keratoconjunctivitis

NCT04376970

Phase 4 Completed 51 enrolled Military Hospital of Tunis
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Purpose: To compare efficiency and tolerance between topical 0.5% cyclosporine A and fluorometholone in patients with subepithelial corneal infiltrates (SEIs). Methods : A prospective double-blind randomized study was conducted involving 72 eyes, 38 treated with topical fluorometholone and 34 eyes treated with cyclosporine A 0.5% eyedrops, having SEIs. Treatment was considered successful if there was reduction of SEIs and improvement in visual acuity (two snellen lines). Tolerance was mainly evaluated by Schirmer test, conjunctival hyperemia and burning sensation upon eyedrops instillation.

Timeline

Start
2017-04-01
Primary completion
2019-04-01
Completion
2019-04-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cyclosporine Peptide 0.5 % Topical
Comparator Fluorometholone Other / unclassified 0.1 % Topical