Trial | NCT00799552  Report issue

Title

Safety and Efficacy Study of RX-10045 on the Signs and Symptoms of Dry Eye
A Phase II, Multi-Center, Double-Masked, Randomized, Placebo Controlled, Study on the Safety and Efficacy of RX-10045 on the Signs and Symptoms of Dry Eye in Every Day Environmental Conditions and During Provocation Using the Controlled Adverse Environment (CAE) Model

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    rx-10045 ...

  • Study Participants

    232
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.
Study Started
Nov 30
2008
Primary Completion
May 31
2009
Study Completion
Jun 30
2009
Last Update
Sep 24
2010
Estimate

Drug RX-10045

RX-10045 eye drop

Drug Placebo

Placebo eye drop

Placebo Placebo Comparator

RX-10045 Experimental

Criteria 

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
No Results Posted