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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00600288
First received: January 11, 2008
Last updated: September 20, 2011
Last verified: September 2011
History of Changes
  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: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Eye Diseases
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Change in fluorescein staining scores of the cornea [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and Tolerability [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 261
Study Start Date: January 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00600288

Locations
United States, Connecticut
The Eye Care Group
Waterbury, Connecticut, United States, 06708
United States, Maine
Central Maine Eye Care
Lewiston, Maine, United States, 04240
United States, Massachusetts
Ophthalmic Research Associates
North Andover, Massachusetts, United States, 01845
United States, North Carolina
Mundorf Eye Center
Charlotte, North Carolina, United States, 28204
United States, Tennessee
Total Eye Care
Memphis, Tennessee, United States, 38119
Sponsors and Collaborators
Merck
Investigators
Study Director: Saiid Davari Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT00600288     History of Changes
Other Study ID Numbers: 03-111, P08634
Study First Received: January 11, 2008
Last Updated: September 20, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 21, 2013