Status:
COMPLETED
Soothe Versus Refresh
Lead Sponsor:
Pharmaceutical Research Network
Conditions:
Dry Eye Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To determine the ocular efficacy and safety of Soothe and Refresh Tears.
Eligibility Criteria
Inclusion
- adults with a diagnosis of dry eyes
- 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
- contact lens use during the active treatment periods of the trial
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00284999
End Date
August 1 2006
Last Update
August 22 2006
Active Locations (3)
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1
Coastal Research Associates, LLC
Atlanta, Georgia, United States, 30339
2
Michigan Cornea Associates
Southfield, Michigan, United States, 48034
3
Mount Sinai School of Medicine
New York, New York, United States, 10029-6574