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Soothe Versus Refresh

This study has been completed.
Sponsor:
Information provided by:
Pharmaceutical Research Network
ClinicalTrials.gov Identifier:
NCT00284999
First received: January 31, 2006
Last updated: August 21, 2006
Last verified: August 2006
History of Changes
  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-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pharmaceutical Research Network:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 Mount Sinai School of Medicine
Principal Investigator: Christopher Chow, MD Michigan Cornea Associates
Principal Investigator: Douglas G. Day, MD Coastal Research Associates, LLC
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00284999     History of Changes
Other Study ID Numbers: PRN 05-034
Study First Received: January 31, 2006
Last Updated: August 21, 2006
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
 Keratitis
Corneal Diseases
Carboxymethylcellulose Sodium
Laxatives
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013