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
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

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:
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 18, 2014