Soothe Versus Refresh

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00284999
Recruitment Status : Completed
First Posted : February 1, 2006
Last Update Posted : August 22, 2006
Information provided by:
Pharmaceutical Research Network

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

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Drug: Soothe Drug: Refresh Tears Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Study Completion Date : August 2006

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00284999

United States, Georgia
Coastal Research Associates, LLC
Atlanta, Georgia, United States, 30339
United States, Michigan
Michigan Cornea Associates
Southfield, Michigan, United States, 48034
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029-6574
Sponsors and Collaborators
Pharmaceutical Research Network
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 Identifier: NCT00284999     History of Changes
Other Study ID Numbers: PRN 05-034
First Posted: February 1, 2006    Key Record Dates
Last Update Posted: August 22, 2006
Last Verified: August 2006

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Conjunctival Diseases
Corneal Diseases