Back to resultsStudy of INS365 Ophthalmic Solution in Subjects With Dry Eye Disease
Primary Purpose
Dry Eye Disease
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
diquafosol tetrasodium (INS365) Ophthalmic Solution
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Disease
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Change in dry eye testing measures and symptoms
Secondary Outcome Measures
Change in dry eye testing measures and symptoms
Full Information
NCT ID
NCT00404131
First Posted
November 22, 2006
Last Updated
November 28, 2016
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00404131
Brief Title
Study of INS365 Ophthalmic Solution in Subjects With Dry Eye Disease
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 Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
December 2001 (Actual)
Study Completion Date
December 2001 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
diquafosol tetrasodium (INS365) Ophthalmic Solution
Primary Outcome Measure Information:
Title
Change in dry eye testing measures and symptoms
Secondary Outcome Measure Information:
Title
Change in dry eye testing measures and symptoms
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Schaberg, BSN
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
15502479
Citation
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. doi: 10.1097/01.ico.0000133993.14768.a9. Erratum In: Cornea. 2007 May;26(4):514.
Results Reference
result
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Study of INS365 Ophthalmic Solution in Subjects With Dry Eye Disease
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