Study of the Effect of Diquafosol Tetrasodium Ophthalmic Solution, 2% Versus Placebo in Dry Eye Subjects (P08634)
Phase 3
Completed
- Conditions
- Dry Eye Disease
- Interventions
- Drug: diquafosol tetrasodium Ophthalmic Solution, 2%Drug: Non-preserved saline solution (Placebo)
- Registration Number
- NCT00600288
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this pilot study is to evaluate the effect of diquafosol tetrasodium Ophthalmic Solution, 2% in dry eye subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 261
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.
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 diquafosol tetrasodium Ophthalmic Solution, 2% - 2 Non-preserved saline solution (Placebo) -
- Primary Outcome Measures
Name Time Method Change in fluorescein staining scores of the cornea 6 weeks
- Secondary Outcome Measures
Name Time Method Safety and Tolerability 6 weeks