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

Merck Sharp & Dohme LLC0 sites500 target enrollmentFebruary 2001

ConditionsDry Eye Disease

Drugsdiquafosol tetrasodium (INS365) Ophthalmic Solution

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Dry Eye Disease
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 500
Primary Endpoint: change in dry eye testing measures and symptoms
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2001

End Date

September 2002

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme LLC

Responsible Party

Sponsor

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