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Soothe Versus Refresh

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00284999
First Posted: February 1, 2006
Last Update Posted: August 22, 2006
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.
Information provided by:
Pharmaceutical Research Network
  Purpose
To determine the ocular efficacy and safety of Soothe and Refresh Tears.

Condition Intervention Phase
Dry Eye Syndromes Drug: Soothe Drug: Refresh Tears Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment

Further study details as provided by Pharmaceutical Research Network:

Estimated Enrollment: 33
Estimated Study Completion Date: August 2006
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT00284999


Locations
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
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
  More Information

ClinicalTrials.gov Identifier: NCT00284999     History of Changes
Other Study ID Numbers: PRN 05-034
First Submitted: January 31, 2006
First Posted: February 1, 2006
Last Update Posted: August 22, 2006
Last Verified: August 2006

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