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Study of the Effect of Diquafosol Tetrasodium Ophthalmic Solution, 2% Versus Placebo in Dry Eye Subjects (P08634)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: January 11, 2008
Last updated: December 21, 2014
Last verified: December 2014
The purpose of this pilot study is to evaluate the effect of diquafosol tetrasodium Ophthalmic Solution, 2% in dry eye subjects.

Condition Intervention Phase
Dry Eye Disease
Drug: diquafosol tetrasodium Ophthalmic Solution, 2%
Drug: Non-preserved saline solution (Placebo)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change in fluorescein staining scores of the cornea [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Safety and Tolerability [ Time Frame: 6 weeks ]

Enrollment: 261
Study Start Date: January 2008
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: diquafosol tetrasodium Ophthalmic Solution, 2%
1-2 drops administered in each eye 4 times a day for 6 weeks
Placebo Comparator: 2 Drug: Non-preserved saline solution (Placebo)
1-2 drops administered in each eye 4 times a day for 6 weeks


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

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00600288

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Saiid Davari Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00600288     History of Changes
Other Study ID Numbers: P08634
Study First Received: January 11, 2008
Last Updated: December 21, 2014

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Conjunctival Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Pharmaceutical Solutions
Ophthalmic Solutions processed this record on May 25, 2017