Study of INS365 Ophthalmic Solution in Subjects With Dry Eye Disease

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Dry Eye Disease

Treatments: Drug: diquafosol tetrasodium (INS365) Ophthalmic Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00404131

03-105

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind