A Study of INS365 Ophthalmic Solution in Patients With Moderate to Severe Dry Eye Disease
August 26, 2015 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 Patients With Moderate to Severe Dry Eye Disease
To evaluate the efficacy and safety of INS365 Ophthalmic Solution when applied topically in patients with moderate to severe dry eye disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
150
Phase
- Phase 2
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Description
Inclusion Criteria:
- Best corrected visual acuity of at least +0.7 ETDRS
- Six month history of dry eye disease
- Mild severity in two out of five symptoms
- Unanesthetized Schirmer score of less than or equal to 7mm
- Corneal fluorescein staining greater than or equal to 4 out of 15 or lissamine green conjunctival staining of greater than or equal to 5 out of 18
Exclusion Criteria:
- Nasal stimulated Schirmer score of less than 3mm
- Have ongoing ocular infection
- Have congenitally absent meibomian or lacrimal glands
- Have had punctal occlusion within a specified time prior to study
- Wear contact lens and refuse to remove them
- Have other excluded eye conditions.
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 |
|---|
|
Schirmer scores
|
|
Corneal staining
|
|
Conjunctival staining
|
|
Tear break-up time
|
|
Change in artificial tear usage
|
|
Patient-reported improvement of foreign body sensation
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
Visual acuity
|
|
Biomicroscopy
|
|
Ophthalmoscopy
|
|
IOP
|
|
Investigator global severity assessment
|
|
Patient-reported dry eye symptoms other than foreign body sensation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
January 1, 2000
Primary Completion (Actual)
July 1, 2000
Study Completion (Actual)
July 1, 2000
Study Registration Dates
First Submitted
May 15, 2008
First Submitted That Met QC Criteria
May 16, 2008
First Posted (Estimate)
May 19, 2008
Study Record Updates
Last Update Posted (Estimate)
August 27, 2015
Last Update Submitted That Met QC Criteria
August 26, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03-103
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.