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

Completed · Phase 3 · Has a placebo group

Conditions studied: Dry Eye Syndrome

In brief

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.

Key facts

Study ID

NCT04206020

Run by

Mitotech, SA

People needed

610

Starts

2019-12-20

Expected to finish

2020-10-06

Last updated by the study team

2022-01-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• Have been previously exposed to previous SkQ1 Ophthalmic Solution treatment;
• 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;

Where it is running

• Arizona Eye Institute and Cosmetic Laser — Sun City West, Arizona, United States
• Andover Eye Associates — Andover, Massachusetts, United States
• Eye Clinics of South Texas — San Antonio, Texas, United States
• Piedmont Eye Center — Lynchburg, Virginia, United States

Full record on ClinicalTrials.gov

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