A Study of RX-10045 in the Treatment of Dry Eye Disease

A Phase II, Multi-Center, Randomized, Placebo-Controlled, Double-Masked Study of RX-10045 (0.09%) in the Treatment of Dry Eye Disease

The primary purpose of this study is to assess the efficacy, tolerability and safety of RX-10045 Ophthalmic Solution in patients with Dry Eye Disease.

Inclusion Criteria:

1. Have a patient reported history of dry eye in both eyes
2. Presence of dry eye symptoms
3. Presence of dry eye signs, destabilized tear film break-up time and corneal staining

Exclusion Criteria:

1. Known contraindications or sensitivities to study medication or its components
2. Any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters
3. Use of disallowed medication during the period indicated prior to the enrollment or during the study
4. Be a female who is currently pregnant, planning a pregnancy, lactating, or not using a medically acceptable form of birth control