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

• ClinicalTrials.gov Identifier: NCT00799552
• Recruitment Status: Completed
• First Posted: December 1, 2008
• Last Update Posted: September 24, 2010
• Sponsor: Resolvyx Pharmaceuticals, Inc
• Information provided by: Resolvyx Pharmaceuticals, Inc

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Dry Eye Syndrome	Drug: RX-10045; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 232 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: November 2008
• Actual Primary Completion Date: May 2009
• Actual Study Completion Date: June 2009

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo eye drop
Experimental: RX-10045	Drug: RX-10045; RX-10045 eye drop

Outcome Measures

Primary Outcome Measures :

1. Corneal fluorescein staining and integrated subject diary data [ Time Frame: 28 days ]

Secondary Outcome Measures :

1. Changes in dry eye signs and symptoms [ Time Frame: 28 days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Massachusetts

ORA Clinical

Andover, Massachusetts, United States, 01810

Sponsors and Collaborators

Resolvyx Pharmaceuticals, Inc

Investigators

• Principal Investigator: Gail Torkildsen, MD; Ophthalmic Research Associates, Andover, MA
• Principal Investigator: John Lonsdale, MD; Central Maine Eye Care, Lewiston, ME
• Principal Investigator: Joel Geffin, MD; The Eye Care Group, Waterbury, CT

More Information

• Responsible Party: Per Gjorstrup, Chief Medical Officier, Resolvyx Pharmaceuticals, Inc
• ClinicalTrials.gov Identifier: NCT00799552 History of Changes
• Other Study ID Numbers: 08-004-03
• First Posted: December 1, 2008
• Last Update Posted: September 24, 2010
• Last Verified: September 2010

Keywords provided by Resolvyx Pharmaceuticals, Inc:

Keratoconjunctivitis Sicca; Dry eye; Resolvin

Additional relevant MeSH terms:

Keratoconjunctivitis Sicca; Dry Eye Syndromes; Signs and Symptoms; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Eye Diseases; Keratitis; Corneal Diseases; Lacrimal Apparatus Diseases