Study of INS365 Ophthalmic Solution in Subjects With Dry Eye Disease
Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00404131
Collaborator
(none)
500
9
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Anticipated 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
:
Mar 1, 2001
Actual Primary Completion Date
:
Dec 1, 2001
Actual Study Completion Date
:
Dec 1, 2001
Outcome Measures
Primary Outcome Measures
- Change in dry eye testing measures and symptoms []
Secondary Outcome Measures
- Change in dry eye testing measures and symptoms []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
No locations specified.Sponsors and Collaborators
- Merck Sharp & Dohme LLC
Investigators
- Study Director: Amy Schaberg, BSN,
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier:
NCT00404131
Other Study ID Numbers:
- 03-105
First Posted:
Nov 27, 2006
Last Update Posted:
Nov 29, 2016
Last Verified:
Nov 1, 2016
Additional relevant MeSH terms: