Last updated: December 20, 2021
Sponsor: Mitotech, SA
Overall Status: Completed
Phase
3
Condition
Dry Eye Disease
Dry Eyes
Sjogren's Syndrome
Treatment
N/AClinical Study ID
NCT03764735
18-110-0004
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 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 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: 452
Study Start date:
December 06, 2018
Estimated Completion Date:
February 09, 2019
Study Description
Connect with a study center
Cornea & Cataract Consultants of Arizona
Phoenix, Arizona 85032
United StatesSite Not Available
Eye Research Foundation
Newport Beach, California 92663
United StatesSite Not Available
Midwest Cornea Associates
Indianapolis, Indiana 46290
United StatesSite Not Available
Eye Care Insititute
Louisville, Kentucky 40206
United StatesSite Not Available
Central Maine Eye Care
Lewiston, Maine 04240
United StatesSite Not Available
Andover Eye Associates
Andover, Massachusetts 01810
United StatesSite Not Available
Vita Eye Clinic
Shelby, North Carolina 28150
United StatesSite Not Available
Total Eye Care, PA
Memphis, Tennessee 38119
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.