NCT03764735

Study of SkQ1 as Treatment for Dry-eye Syndrome

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 452 (actual)
• Sponsor: Mitotech, SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Dry Eye Syndrome

Interventions

Type	Name	Description
DRUG	Low Dose - SkQ1	SkQ1 Low dose ophthalmic solution
DRUG	High dose - SkQ1	SkQ1 High Dose ophthalmic solution
DRUG	SkQ1 (Vehicle)	Vehicle for SkQ1 ophthalmic solution

Timeline

• Start date: 2018-12-06
• Primary completion: 2019-02-09
• Completion: 2019-02-09
• First posted: 2018-12-05
• Last updated: 2022-01-19
• Results posted: 2022-01-19

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study