drugset / Trial / NCT07588074
Tolerability Comparison of Flarex to Lotemax SM
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fluorometholone | Other / unclassified | 0.1 % | Topical |
| Comparator | Loteprednol Etabonate | Other / unclassified | 0.38 % | Topical |