Trial | NCT02326090  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    cis-urocanic acid ...

  • Study Participants

    161
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.
Study Started
Dec 31
2014
Primary Completion
Apr 30
2015
Study Completion
Apr 30
2015
Last Update
Sep 09
2015
Estimate

Drug cis-UCA ophthalmic solution 1.0%

Drug cis-UCA ophthalmic solution 2.5%

Drug Placebo ophthalmic solution

cis-UCA ophthalmic solution 1.0% Active Comparator

One drop in each eye

cis-UCA ophthalmic solution 2.5% Active Comparator

One drop in each eye

Placebo ophthalmic solution Placebo Comparator

One drop in each eye

Criteria 

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.
No Results Posted