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Vehicle-Controlled Study of SkQ1 as Treatment for Dry-eye Syndrome — VISTA-2  

Dry Eye Syndrome Clinical Trial

Official title:
A Phase 3, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Study of Safety and Efficacy of SkQ1 Ophthalmic Solution in the Environment and the Controlled Adverse Environmental (CAE®) Model for the Treatment of Dry Eye Syndrome

Clinical Trial Summary

The purpose of this study is to evaluate whether SkQ1 Ophthalmic Solution is safe and effective compared to Vehicle for the treatment of the signs and symptoms of dry eye syndrome.

Clinical Trial Description

Multi-center, double-masked, randomized, placebo-controlled study comprising 5 visits over the course of approximately 9 weeks. Qualified subjects are randomized 1:1 to receive either SkQ1 Ophthalmic Solution, or Placebo (vehicle of SkQ1 Ophthalmic Solution). The Primary Endpoints are: Change from Baseline (Visit 2) to Visit 5 of Ocular Discomfort; Change from Baseline (Visit 2) to Visit 5 of conjunctival fluorescein staining (sum of temporal and nasal regions) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04206020
Study type Interventional
Source Mitotech, SA
Contact
Status Completed
Phase Phase 3
Start date December 20, 2019
Completion date October 6, 2020
View Details
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