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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00799552
Recruitment Status : Completed
First Posted : December 1, 2008
Last Update Posted : September 24, 2010
Information provided by:
Resolvyx Pharmaceuticals, Inc

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

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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

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Placebo eye drop

Experimental: RX-10045 Drug: RX-10045
RX-10045 eye drop

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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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

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 identifier (NCT number): NCT00799552

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United States, Massachusetts
ORA Clinical
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
Resolvyx Pharmaceuticals, Inc
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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
Additional Information:
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Responsible Party: Per Gjorstrup, Chief Medical Officier, Resolvyx Pharmaceuticals, Inc Identifier: NCT00799552    
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
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Conjunctival Diseases
Corneal Diseases