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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00600288
First Posted: January 24, 2008
Last Update Posted: January 9, 2015
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
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: Quadruple (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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
Information from the National Library of Medicine

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): NCT00600288


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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00600288     History of Changes
Other Study ID Numbers: P08634
03-111
First Submitted: January 11, 2008
First Posted: January 24, 2008
Last Update Posted: January 9, 2015
Last Verified: December 2014

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Pharmaceutical Solutions
Ophthalmic Solutions


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