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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
History of Changes

November 26, 2008
September 20, 2010
November 2008
May 2009   (final data collection date for primary outcome measure)
Corneal fluorescein staining and integrated subject diary data [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Changes in dry eye signs and symptoms [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00799552 on ClinicalTrials.gov Archive Site
Changes in dry eye signs and symptoms [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study of RX-10045 on the Signs and Symptoms of Dry Eye
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

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Dry Eye Syndrome
  • Drug: RX-10045
    RX-10045 eye drop
  • Drug: Placebo
    Placebo eye drop
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: RX-10045
    Intervention: Drug: RX-10045
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
232
June 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00799552
08-004-03
Yes
Per Gjorstrup, Chief Medical Officier, Resolvyx Pharmaceuticals, Inc
Resolvyx Pharmaceuticals, Inc
Not Provided
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
Resolvyx Pharmaceuticals, Inc
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP