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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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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

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Related Info 

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