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

Sponsor

Resolvyx Pharmaceuticals, Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT00799552

Collaborator

(none)

232

Enrollment

Location

Arms

Duration (Months)

33.3

Patients Per Site Per Month

Study Details

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

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 :

Nov 1, 2008

Actual Primary Completion Date :

May 1, 2009

Actual Study Completion Date :

Jun 1, 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

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

Corneal fluorescein staining and integrated subject diary data [28 days]

Secondary Outcome Measures

Changes in dry eye signs and symptoms [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

	Site	City	State	Country	Postal Code
1	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