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 solutions are safe and effective compared to placebo for the treatment of the signs and symptoms of dry eye syndrome.
Key facts
- Study ID
- NCT03764735
- Run by
- Mitotech, SA
- People needed
- 452
- Starts
- 2018-12-06
- Expected to finish
- 2019-02-09
- 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 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;
Where it is running
- Cornea & Cataract Consultants of Arizona — Phoenix, Arizona, United States
- Eye Research Foundation — Newport Beach, California, United States
- Eye Care Insititute — Louisville, Kentucky, United States
- Central Maine Eye Care — Lewiston, Maine, United States
- Andover Eye Associates — Andover, Massachusetts, United States
- Vita Eye Clinic — Shelby, North Carolina, United States
- Total Eye Care, PA — Memphis, Tennessee, United States
Full record on ClinicalTrials.gov
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