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

A Phase II, Multi-Center, Double-Masked, Randomized, Placebo Controlled, Study on the Safety and Efficacy of RX-10045 on the Signs and Symptoms of Dry Eye in Every Day Environmental Conditions and During Provocation Using the Controlled Adverse Environment (CAE) Model

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.

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