Safety and Efficacy Study of RX-10045 on the Signs and Symptoms of Dry Eye
- Registration Number
- NCT00799552
- Lead Sponsor
- Resolvyx Pharmaceuticals, Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 232
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - RX-10045 RX-10045 -
- Primary Outcome Measures
Name Time Method Corneal fluorescein staining and integrated subject diary data 28 days
- Secondary Outcome Measures
Name Time Method Changes in dry eye signs and symptoms 28 days
Trial Locations
- Locations (1)
ORA Clinical
🇺🇸Andover, Massachusetts, United States