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The Effects of Diquafosol Tetrasodium Ophthalmic Solution, 2% in Subjects With Dry Eye Disease (P08637)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00831662
First received: January 27, 2009
Last updated: December 21, 2014
Last verified: December 2014

January 27, 2009
December 21, 2014
January 2009
December 2009   (final data collection date for primary outcome measure)
Proportion of subjects that achieve clearing of fluorescein staining of the central cornea (NEI scale). Subjects must have a score of 0 on the NEI scale at Week 6 to be considered responders. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00831662 on ClinicalTrials.gov Archive Site
Proportion of subjects that achieve a 2-or-more-unit reduction of fluorescein staining of the central cornea (NEI scale) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Effects of Diquafosol Tetrasodium Ophthalmic Solution, 2% in Subjects With Dry Eye Disease (P08637)
Not Provided

The purpose of this study is to confirm the safety and efficacy of diquafosol tetrasodium ophthalmic solution, 2% vs. placebo, in subjects with dry eye disease.

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%
    One to two drops in each eye QID for 6 weeks
  • Drug: Placebo
    One to two drops in each eye QID for 6 weeks
  • Placebo Comparator: Arm 2
    Intervention: Drug: Placebo
  • Experimental: Arm 1
    Intervention: Drug: Diquafosol tetrasodium ophthalmic solution, 2%
Tauber J, Davitt WF, Bokosky JE, Nichols KK, Yerxa BR, Schaberg AE, LaVange LM, Mills-Wilson MC, Kellerman DJ. Double-masked, placebo-controlled safety and efficacy trial of diquafosol tetrasodium (INS365) ophthalmic solution for the treatment of dry eye. Cornea. 2004 Nov;23(8):784-92. Erratum in: Cornea. 2007 May;26(4):514.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
490
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have best corrected visual acuity in both eyes of at least +0.7 or better
  • Central corneal staining of 3 on the NEI scale
  • If female, are non-pregnant or non-lactating
  • Have a history of dry eye disease in both eyes
  • Have normal lid anatomy

Exclusion Criteria:

  • Unable to withhold the use of contact lenses during the study or 2 weeks prior to the study
  • Have had ocular surface surgery within the past year
  • Are considered legally blind in one eye
  • Have a serious medical condition which could confound study assessments
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States,   Canada
 
NCT00831662
P08637, 03-113
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Reza Haque, MD, PhD Medical Monitor, Inspire
Merck Sharp & Dohme Corp.
December 2014

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