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Study of SkQ1 as Treatment for Dry-eye Syndrome — VISTA-1  

Dry Eye Syndrome Clinical Trial

Official title:
A Phase 3, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of SkQ1 Ophthalmic Solution for the Treatment of Dry Eye Syndrome

Clinical Trial Summary

The purpose of this study is to evaluate whether SkQ1 ophthalmic solutions are safe and effective compared to placebo 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 1:1:1 to receive either High Dose SkQ1 ophthalmic solution, Low Dose SkQ1 ophthalmic solution, or Placebo (vehicle of SkQ1 ophthalmic solution). The Primary Endpoints are: Change from Baseline (Visit 2) to Visit 5 in Corneal Fluorescein Staining; Change from Baseline (Visit 2) to Visit 5 in Grittiness Symptom ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03764735
Study type Interventional
Source Mitotech, SA
Contact
Status Completed
Phase Phase 3
Start date December 6, 2018
Completion date February 9, 2019
View Details
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