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
PHASE4
33 participants
INTERVENTIONAL
2006-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Interventions
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Soothe
Refresh Tears
Eligibility Criteria
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Inclusion Criteria
* Schirmer's with anesthesia grade between 1-7 mm inclusive after five (5) minutes in at least one eye
* a corneal staining grade of greater than or equal to 2 (scale 0-4) in the same qualifying eye as the Schirmer's test
Exclusion Criteria
* history of Sjogren's Syndrome
* temporary punctal occlusion that is still effective
* the current or anticipated use during the study of punctual plugs
* current treatment with Restasis
18 Years
ALL
No
Sponsors
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Pharmaceutical Research Network
OTHER
Principal Investigators
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William C. Stewart, MD
Role: STUDY_DIRECTOR
Pharmaceutical Research Network, LLC
Penny Asbell, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Christopher Chow, MD
Role: PRINCIPAL_INVESTIGATOR
Michigan Cornea Associates
Douglas G. Day, MD
Role: PRINCIPAL_INVESTIGATOR
Coastal Research Associates, LLC
Locations
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Coastal Research Associates, LLC
Atlanta, Georgia, United States
Michigan Cornea Associates
Southfield, Michigan, United States
Mount Sinai School of Medicine
New York, New York, United States
Countries
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Other Identifiers
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PRN 05-034
Identifier Type: -
Identifier Source: org_study_id