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

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

Study Description
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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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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, 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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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    Key Record Dates
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