Study of INS365 Ophthalmic Solution in Subjects With Dry Eye Disease
November 28, 2016 updated by: Merck Sharp & Dohme LLC
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
500
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
Change in dry eye testing measures and symptoms
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Secondary Outcome Measures
Outcome Measure |
|---|
|
Change in dry eye testing measures and symptoms
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2001
Primary Completion (Actual)
December 1, 2001
Study Completion (Actual)
December 1, 2001
Study Registration Dates
First Submitted
November 22, 2006
First Submitted That Met QC Criteria
November 22, 2006
First Posted (Estimate)
November 27, 2006
Study Record Updates
Last Update Posted (Estimate)
November 29, 2016
Last Update Submitted That Met QC Criteria
November 28, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03-105
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.