Status:
COMPLETED
Safety and Efficacy Study of RX-10045 on the Signs and Symptoms of Dry Eye
Lead Sponsor:
Resolvyx Pharmaceuticals, Inc
Conditions:
Dry Eye Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT00799552
Start Date
November 1 2008
End Date
June 1 2009
Last Update
September 24 2010
Active Locations (1)
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1
ORA Clinical
Andover, Massachusetts, United States, 01810