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

Completed · Phase 2 · Has a placebo group

Conditions studied: Dry Eye Syndrome

In brief

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.

Key facts

Study ID

NCT00799552

Run by

Resolvyx Pharmaceuticals, Inc

People needed

232

Starts

2008-11-01

Expected to finish

2009-06-01

Last updated by the study team

2010-09-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• ORA Clinical — Andover, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.