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 Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00600288
First received: January 11, 2008
Last updated: September 20, 2011
Last verified: September 2011

January 11, 2008
September 20, 2011
January 2008
May 2008   (final data collection date for primary outcome measure)
Change in fluorescein staining scores of the cornea [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00600288 on ClinicalTrials.gov Archive Site
Safety and Tolerability [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of the Effect of Diquafosol Tetrasodium Ophthalmic Solution, 2% Versus Placebo in Dry Eye Subjects
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

The purpose of this pilot study is to evaluate the effect of diquafosol tetrasodium Ophthalmic Solution, 2% in dry eye subjects.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Dry Eye Disease
  • Drug: diquafosol tetrasodium Ophthalmic Solution, 2%
    1-2 drops administered in each eye 4 times a day for 6 weeks
  • Drug: Non-preserved saline solution (Placebo)
    1-2 drops administered in each eye 4 times a day for 6 weeks
  • Experimental: 1
    Intervention: Drug: diquafosol tetrasodium Ophthalmic Solution, 2%
  • Placebo Comparator: 2
    Intervention: Drug: Non-preserved saline solution (Placebo)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
261
Not Provided
May 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00600288
03-111, P08634
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Saiid Davari Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP