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Study of INS365 Ophthalmic Solution in Subjects With Dry Eye Disease

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ClinicalTrials.gov Identifier: NCT00403715
Recruitment Status : Completed
First Posted : November 27, 2006
Last Update Posted : November 29, 2016
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Dry Eye Disease Drug: diquafosol tetrasodium (INS365) Ophthalmic Solution Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
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
Study Start Date : February 2001
Actual Primary Completion Date : September 2002
Actual Study Completion Date : September 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00403715     History of Changes
Other Study ID Numbers: 03-104
First Posted: November 27, 2006    Key Record Dates
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