Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-24 @ 10:10 PM
NCT ID:
NCT03764735
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;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03764735
Study Brief:
Protocol Section:
NCT03764735