Phase 2 Study With Cis-UCA Ophthalmic Solutions in Subjects With Dry Eye



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:December 2014
End Date:April 2015

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A Phase 2, Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of 1.0% and 2.5% Cis-UCA Ophthalmic Solutions in Subjects With Dry Eye

The objective of the Phase 2 study is to compare the safety and efficacy of cis-UCA
Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.


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.
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