Phase 2 Study With Cis-UCA Ophthalmic Solutions in Subjects With Dry Eye
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Key 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 or desire to use eye drops.
Key Exclusion Criteria:
Have any clinically significant eye findings that require therapeutic treatment, and/or in the opinion of the Investigator may interfere with study parameters;
Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
Have used Restasis® within 30 days of Visit 1;
Have any planned ocular and/or lid surgeries over the study period;
Be a woman who is pregnant, nursing or planning a pregnancy;
Be unwilling to submit a urine pregnancy test at Visit 1 and Visit 4 (or early termination visit) if of childbearing potential;
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;
Be unable or unwilling to follow instructions, including participation in all study assessments and visits.