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

A Multicenter, Randomized, Double-Masked, Placebo-Controlled Phase II Study to Evaluate the Safety and Efficacy of Pro-ocular™ 0.5% and 1% in Patients With Dry Eye Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: SIFI SpA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	Pro-ocular gel	Topical gel in multidose formulation to be applied laterally to the forehead twice a day, morning and night for 3 months
DRUG	Placebo gel	Topical gel in multidose formulation to be applied laterally to the forehead twice a day, morning and night for 3 months

Timeline

• Start date: 2021-02-18
• Primary completion: 2022-10-27
• Completion: 2022-10-27
• First posted: 2020-11-27
• Last updated: 2022-12-23

Locations

4 sites across 1 country: Italy