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

Phase 2

Completed

• Conditions: Dry Eye Syndrome
• Interventions: Drug: Placebo; Drug: RX-10045

• 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

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-26
• Study First Submitted QC: 2008-11-28
• Study First Posted: 2008-12-01
• Primary Completion: 2009-05
• Study Completion: 2009-06
• Status Verified: 2010-09
• Disposition First Submitted: 2010-09-07
• Disposition First Submitted QC: 2010-09-07
• Disposition First Posted: 2010-09-20
• Last Update Submitted: 2010-09-20
• Last Update Posted: 2010-09-24

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