Last updated: December 20, 2021
Sponsor: Mitotech, SA
Overall Status: Completed
Phase
3
Condition
Sjogren's Syndrome
Eye Disease
Dry Eye Disease
Treatment
N/AClinical Study ID
NCT04206020
19-110-0011
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
Exclusion Criteria:
- 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 plannedover 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 birthcontrol;
- 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 subjectat significant risk, may confound the study results, or may interfere significantlywith the subject's participation in the study;
- Be currently enrolled in an investigational drug or device study or have used aninvestigational drug or device within 30 days of Visit 1;
Study Design
Total Participants: 610
Study Start date:
December 20, 2019
Estimated Completion Date:
October 06, 2020
Study Description
Connect with a study center
Arizona Eye Institute and Cosmetic Laser
Sun City West, Arizona 85375
United StatesSite Not Available
Andover Eye Associates
Andover, Massachusetts 01810
United StatesSite Not Available
Eye Clinics of South Texas
San Antonio, Texas 78209
United StatesSite Not Available
Piedmont Eye Center
Lynchburg, Virginia 24502
United StatesSite Not Available
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