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COMPLETED
NCT07588074
PHASE4

Tolerability Comparison of Flarex to Lotemax SM

Sponsor: Harrow Inc

View on ClinicalTrials.gov

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.

Official title: Tolerability Comparison of Fluorometholone Acetate Ophthalmic Suspension 0.1% (Flarex) to Loteprednol Etabonate Ophthalmic Gel 0.38% (Lotemax SM)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2021-05-01

Completion Date

2021-06-30

Last Updated

2026-09-22

Healthy Volunteers

No

Interventions

DRUG

Fluorometholone Acetate Ophthalmic Suspension 0.1%

One drop, single instillation, in randomized eye

DRUG

Loteprednol Etabonate Ophthalmic Gel 0.38%

One drop, single instillation, in randomized eye

Locations (1)

Williamson Eye Center

Baton Rouge, Louisiana, United States