drugset
drugset / Trial / NCT04645446

Safety and Efficacy of Two Different Concentrations (0.5% and 1%) of Progesterone Topical Gel Compared to Placebo in Patients Diagnosed With Moderate to Severe Dry Eye Syndrome

NCT04645446 ↗

Phase 2 Completed 96 enrolled SIFI SpA
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Phase 2 clinical trial. The study objective is to evaluate the safety and efficacy of two different concentrations (0.5% and 1%) of progesterone topical gel compared to placebo, when administered twice a day for 3 months (12 weeks) in patients diagnosed with moderate to severe dry eye syndrome.

Timeline

Start
2021-02-18
Primary completion
2022-10-27
Completion
2022-10-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Progesterone Other / unclassified 0.35 mg Topical
Subject Progesterone Other / unclassified 0.7 mg Topical

Indications

dry eye syndrome