A Study of RX-10045 in the Treatment of Dry Eye Disease
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | August 2012 |
| End Date: | November 2012 |
| Contact: | Sunita Saigal |
| Phone: | 978-685-8900 |
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
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