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

Mitotech, SA7 sites in 1 country452 target enrollmentDecember 6, 2018

ConditionsDry Eye Syndrome

InterventionsSkQ1 (Vehicle)Low Dose - SkQ1 High dose - SkQ1

DrugsLow Dose - SkQ1 High dose - SkQ1 SkQ1 (Vehicle)

Overview

Phase: Phase 3
Intervention: SkQ1 (Vehicle)
Conditions: Dry Eye Syndrome
Sponsor: Mitotech, SA
Enrollment: 452
Locations: 7
Primary Endpoint: Central Corneal Staining Change From Baseline
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

December 6, 2018

End Date

February 9, 2019

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Mitotech, SA

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Be at least 18 years of age;
•Provide written informed consent;
•Have a subject reported history of dry eye;
•Have a history of use of eye drops for dry eye symptoms ;
•Ocular Discomfort;
•Schirmer's Test score;
•Have corneal fluorescein staining ;
•Have lissamine green conjunctival Staining ;
•Have a conjunctival redness;

Exclusion Criteria

•Have participated in the previous SkQ1 ophthalmic solution Phase 2 treatment study;
•Have any clinically significant slit lamp findings at Visit 1;
•Be diagnosed with an ongoing ocular infection or active ocular inflammation at Visit 1;
•Have had any ocular and/or lid surgeries within 6 months of Visit 1 or any planned over the study period;
•Have an uncontrolled systemic disease;
•Be a woman who is pregnant, nursing or planning a pregnancy;
•Be a woman of childbearing potential who is not using an acceptable means of birth control;
•Have a known allergy and/or sensitivity to the study drug or its components ;
•Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study;
•Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1;