Safety and Efficacy Study of RX-10045 on the Signs and Symptoms of Dry Eye

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the safety and efficacy of RX-10045 to placebo for the treatment of the signs and symptoms of dry eye.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Resolvyx Pharmaceuticals, Inc

Criteria

Inclusion Criteria:

• Be at least 18 years of age;

• Have provided written informed consent;

• Have a history of dry eye for at least 6 months prior to enrollment;

• Have a history of use or desire to use eye drops for dry eye symptoms within the past 6 months;

• Demonstrate a response when exposed to the CAE.

Exclusion Criteria:

• Have an on-going ocular infection, or active ocular inflammation

• Have worn contact lenses within 72 hours of Visit 1 or have anticipated use of contact lenses during the study;

• Have contact lens-induced dry eye;

• Have previously had laser in situ keratomileusis (LASIK) surgery;

• Be using or have anticipated use of temporary punctual plugs during the study;

• Have best corrected visual acuity > +0.7 in both eyes;

• Be a woman who is pregnant, nursing or planning a pregnancy;

• Have a known allergy and/or sensitivity to the test article or its components;

• Be currently using any medication known to cause ocular drying that is not used on a stable dosing regimen for at least 30 days