We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of INS365 Ophthalmic Solution in Subjects With Dry Eye Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00404131
First Posted: November 27, 2006
Last Update Posted: November 29, 2016
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
November 22, 2006
November 27, 2006
November 29, 2016
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
Not Provided
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
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Dry Eye Disease
Drug: diquafosol tetrasodium (INS365) Ophthalmic Solution
Not Provided
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
500
December 2001
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00404131
03-105
Not Provided
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Amy Schaberg, BSN
Merck Sharp & Dohme Corp.
November 2016

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