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
  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:


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
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
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

Additional Information:
No publications provided

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:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Signs and Symptoms
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases

ClinicalTrials.gov processed this record on April 17, 2014