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Trial record 27 of 8830 for:    Eye AND Eye Diseases

Study of Diquafosol Tetrasodium Ophthalmic Solution in Subjects With Dry Eye Disease

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.
ClinicalTrials.gov Identifier: NCT00403975
Recruitment Status : Completed
First Posted : November 27, 2006
Last Update Posted : February 22, 2016
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE November 22, 2006
First Posted Date  ICMJE November 27, 2006
Last Update Posted Date February 22, 2016
Study Start Date  ICMJE June 2004
Actual Primary Completion Date November 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 24, 2006)
Change in dry eye testing measures
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00403975 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2006)
Change in dry eye testing measures and symptoms
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Diquafosol Tetrasodium Ophthalmic Solution in Subjects With Dry Eye Disease
Official Title  ICMJE A Multi-Center, Parallel Group, Double-Masked, Randomized, Placebo-Controlled Study of Multiple Ocular Instillations of Diquafosol Tetrasodium Ophthalmic Solution, 2% in Subjects With Dry Eye Disease
Brief Summary The purpose of this trial is to assess the effectiveness and safety of 2% diquafosol tetrasodium ophthalmic solution versus placebo following 6 weeks of treatment in subjects with mild to moderate dry eye disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Dry Eye Disease
Intervention  ICMJE Drug: diquafosol tetrasodium ophthalmic solution, 2%
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 25, 2014)
640
Original Enrollment  ICMJE
 (submitted: November 24, 2006)
520
Actual Study Completion Date  ICMJE November 2004
Actual Primary Completion Date November 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • best corrected visual acuity in both eyes of at least +0.7
  • six-month documented history of dry eye disease
  • as least mild severity in 1 of the 5 dry eye symptoms
  • corneal fluorescein staining of greater than or equal to 3 and less than or equal to 6 (out of 15)

Exclusion Criteria:

  • permanent conjunctival goblet cell loss or scarring conditions
  • ongoing contact lens wear
  • current topical ophthalmic medication use
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00403975
Other Study ID Numbers  ICMJE 03-109
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Merck Sharp & Dohme Corp.
Verification Date February 2016

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