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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00600288 |
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Date of registration:
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11/01/2008 |
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Primary sponsor: |
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Public title:
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Study of the Effect of Diquafosol Tetrasodium Ophthalmic Solution, 2% Versus Placebo in Dry Eye Subjects
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Scientific title:
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A Multi-Center, Parallel-Group, Double-Masked, Randomized, Placebo-Controlled Study of the Effects of Diquafosol Tetrasodium Ophthalmic Solution, 2% and Placebo in Subjects With Dry Eye Disease |
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Date of first enrolment:
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January 2008 |
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Target sample size:
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261 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00600288 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Saiid Davari |
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Address:
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Telephone:
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Email:
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Affiliation:
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Merck |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Provide written informed consent prior to any study procedures being performed.
- Have a best corrected visual acuity (BCVAof +0.7 or better.
- Have a history of dry eye (keratoconjunctivitis sicca) in both eyes
- Have ongoing dry eye disease, in the same qualifying eye or both eyes.
Exclusion Criteria:
- Have previously had LASIK refractive surgery.
- Use of topical ophthalmic medications, preps, gels and lid scrubs during study.
- Have had penetrating intraocular surgery in the past 90 days.
- Have had other ocular surface surgery (e.g., refractive, pterygium) within the past
year.
- Have a diagnosis of an on-going ocular infection, clinically significant blepharitis,
lid margin inflammation, Stevens-Johnson syndrome or pemphigoid.
- Any serious ocular systemic disease or uncontrolled medical condition.
- Exposure to any investigational drug within 30 days of study start.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Dry Eye Disease
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Intervention(s)
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Drug: diquafosol tetrasodium Ophthalmic Solution, 2%
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Drug: Non-preserved saline solution (Placebo)
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Primary Outcome(s)
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Change in fluorescein staining scores of the cornea
[Time Frame: 6 weeks]
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Secondary Outcome(s)
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Safety and Tolerability
[Time Frame: 6 weeks]
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Secondary ID(s)
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03-111
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P08634
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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