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

This study has been completed.

Sponsor:

Information provided by:

Resolvyx Pharmaceuticals, Inc

ClinicalTrials.gov Identifier:

NCT00799552

First received: November 26, 2008

Last updated: September 20, 2010

Last verified: September 2010

History of Changes

Purpose

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	Intervention	Phase
Dry Eye Syndrome	Drug: RX-10045 Drug: Placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Genetics Home Reference related topics: keratitis-ichthyosis-deafness syndrome

U.S. FDA Resources

Further study details as provided by Resolvyx Pharmaceuticals, Inc:

Primary Outcome Measures:

Corneal fluorescein staining and integrated subject diary data [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in dry eye signs and symptoms [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]


Enrollment:	232
Study Start Date:	November 2008
Study Completion Date:	June 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo	Drug: Placebo Placebo eye drop
Experimental: RX-10045	Drug: RX-10045 RX-10045 eye drop

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00799552

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
Study First Received:	November 26, 2008
Last Updated:	September 20, 2010
Health Authority:	United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 28, 2016

To Top