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Study of INS365 Ophthalmic Solution in Subjects With Dry Eye Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00403715
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.
  Purpose
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.

Condition Intervention Phase
Dry Eye Disease Drug: diquafosol tetrasodium (INS365) Ophthalmic Solution Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • change in dry eye testing measures and symptoms

Secondary Outcome Measures:
  • change in dry eye testing measures and symptoms

Estimated Enrollment: 500
Study Start Date: February 2001
Study Completion Date: September 2002
Primary Completion Date: September 2002 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00403715


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Amy Schaberg, BSN
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00403715     History of Changes
Other Study ID Numbers: 03-104
First Submitted: November 22, 2006
First Posted: November 27, 2006
Last Update Posted: November 29, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Pharmaceutical Solutions
Ophthalmic Solutions