Safety and Efficacy Study of RX-10045 on the Signs and Symptoms of Dry Eye
This study has been completed.
Sponsor:
Resolvyx Pharmaceuticals, Inc
Information provided by:
Resolvyx Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00799552
First received: November 26, 2008
Last updated: September 20, 2010
Last verified: September 2010
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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 May 21, 2013