Safety and Efficacy Study of RX-10045 on the Signs and Symptoms of Dry Eye
NCT ID: NCT00799552
Last Updated: 2010-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
232 participants
INTERVENTIONAL
2008-11-30
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
Placebo eye drop
RX-10045
RX-10045
RX-10045 eye drop
Interventions
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RX-10045
RX-10045 eye drop
Placebo
Placebo eye drop
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Resolvyx Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Resolvyx Pharmaceuticals, Inc
Principal Investigators
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Gail Torkildsen, MD
Role: PRINCIPAL_INVESTIGATOR
Ophthalmic Research Associates, Andover, MA
John Lonsdale, MD
Role: PRINCIPAL_INVESTIGATOR
Central Maine Eye Care, Lewiston, ME
Joel Geffin, MD
Role: PRINCIPAL_INVESTIGATOR
The Eye Care Group, Waterbury, CT
Locations
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ORA Clinical
Andover, Massachusetts, United States
Countries
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Related Links
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Related Info
Other Identifiers
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08-004-03
Identifier Type: -
Identifier Source: org_study_id