drugset / Trial / NCT07588074

Tolerability Comparison of Flarex to Lotemax SM

NCT07588074

Phase 4 Completed 40 enrolled Harrow Inc Eyevance Pharmaceuticals · collab
RandomizedCrossoverDouble-blindTreatment

Summary

This study compared the ocular tolerability of fluorometholone acetate ophthalmic suspension 0.1% (FLAREX) to loteprednol etabonate ophthalmic gel 0.38% (Lotemax SM) in adult subjects. Each subject received one drop of each product, one in each eye, in a randomized, double-masked design. Comfort, impact on vision, and palpebral conjunctival injection were evaluated at 30 seconds, 5 minutes, and 10 minutes after instillation.

Timeline

Start
2021-05-01
Primary completion
2021-06-30
Completion
2021-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluorometholone Other / unclassified 0.1 % Topical
Comparator Loteprednol Etabonate Other / unclassified 0.38 % Topical

Indications