Soothe Versus Refresh

Phase 4

Completed

• Conditions: Dry Eye Syndromes

• Registration Number: NCT00284999
• Lead Sponsor: Pharmaceutical Research Network

Brief Summary

To determine the ocular efficacy and safety of Soothe and Refresh Tears.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-01-31
• Study First Submitted QC: 2006-01-31
• Study First Posted: 2006-02-01
• Status Verified: 2006-08
• Study Completion: 2006-08
• Last Update Submitted: 2006-08-21
• Last Update Posted: 2006-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Trial Locations

Locations (3)

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