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 Intervention Model: Parallel Assignment Masking: Double Blind (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 |
Further study details as provided by Resolvyx Pharmaceuticals, Inc:
Primary Outcome Measures:
- Corneal fluorescein staining and integrated subject diary data [ Time Frame: 28 days ]
Secondary Outcome Measures:
- Changes in dry eye signs and symptoms [ Time Frame: 28 days ]
| 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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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:
| 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 |
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 May 24, 2017