NCT04206020

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 610 (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 Solution is safe and effective compared to Vehicle 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 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)

Conditions

• Dry Eye Syndrome

Interventions

Type	Name	Description
DRUG	SkQ1 Vehicle Solution	SkQ1 Ophthalmic Solution Vehicle
DRUG	SkQ1 Ophthalmic Solution	SkQ1 Ophthalmic Solution

Timeline

• Start date: 2019-12-20
• Primary completion: 2020-10-06
• Completion: 2020-10-06
• First posted: 2019-12-20
• Last updated: 2022-01-19
• Results posted: 2022-01-19

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study