Soothe Versus Refresh
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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. |
ClinicalTrials.gov Identifier: NCT00284999 |
Recruitment Status :
Completed
First Posted : February 1, 2006
Last Update Posted : August 22, 2006
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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 |

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

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
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 |
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 |
ClinicalTrials.gov Identifier: | NCT00284999 |
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 |
Dry Eye Syndromes Lacrimal Apparatus Diseases Eye Diseases |