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Soothe Versus Refresh

Sponsor
Pharmaceutical Research Network (Other)
Overall Status
Completed
CT.gov ID
NCT00284999
Collaborator
(none)
33
Enrollment
3
Locations
11
Patients Per Site

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double
Primary Purpose:
Treatment
Study Completion Date :
Aug 1, 2006

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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

    Sponsors and Collaborators

    • Pharmaceutical Research Network

    Investigators

    • Study Director: William C. Stewart, MD, Pharmaceutical Research Network, LLC
    • Principal Investigator: Penny Asbell, MD, Icahn School of Medicine at Mount Sinai
    • Principal Investigator: Christopher Chow, MD, Michigan Cornea Associates
    • Principal Investigator: Douglas G. Day, MD, Coastal Research Associates, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00284999
    Other Study ID Numbers:
    • PRN 05-034
    First Posted:
    Feb 1, 2006
    Last Update Posted:
    Aug 22, 2006
    Last Verified:
    Aug 1, 2006
    Additional relevant MeSH terms:
    Dry Eye Syndromes

    Study Results

    No Results Posted as of Aug 22, 2006