Study of INS365 Ophthalmic Solution in Subjects With Dry Eye Disease

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00404131
First received: November 22, 2006
Last updated: May 20, 2013
Last verified: May 2013

November 22, 2006
May 20, 2013
March 2001
December 2001   (final data collection date for primary outcome measure)
Change in dry eye testing measures and symptoms
Same as current
Complete list of historical versions of study NCT00404131 on ClinicalTrials.gov Archive Site
Change in dry eye testing measures and symptoms
Same as current
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Not Provided
 
Study of INS365 Ophthalmic Solution in Subjects With Dry Eye Disease
A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Dose-Ranging Study of Multiple Ocular Instillations of INS365 Ophthalmic Solution vs. Placebo in Subjects With Dry Eye Disease

The purpose of this trial is to compare the effectiveness and safety of INS365 Ophthalmic Solution with placebo when applied topically in subjects with dry eye disease.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Dry Eye Disease
Drug: diquafosol tetrasodium (INS365) Ophthalmic Solution
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
Not Provided
December 2001   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • best corrected visual acuity in both eyes of at least +0.7
  • six-month documented history of dry eye disease
  • at least mild severity in 2 of the 4 dry eye symptoms
  • unanesthetized Schirmer score of less than or equal to 7mm
  • corneal fluorescein staining of greater than or equal to 4 (out of 15)

Exclusion Criteria:

  • nasally stimulated Schirmer score of less than 3mm in subjects with an initial Schirmer score of 0mm
  • ongoing contact lens wear
  • current topical ophthalmic medication use
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00404131
03-105
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Merck Sharp & Dohme Corp.
Not Provided
Study Director: Amy Schaberg, BSN
Merck Sharp & Dohme Corp.
May 2013

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