A Study to Determine the Safety and Tolerability of Escalating Doses of INS365 Ophthalmic Solution

Merck Sharp & Dohme LLC62 enrolled

Overview

The purpose of this study is to evaluate the safety and tolerability of INS365 Ophthalmic Solution when applied topically as eyedrops in patients with mild to moderate dry eye disease.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Dry Eye Disease

Interventions

diquafosol tetrasodium (INS365) ophthalmic solutionDRUG

Eligibility

Medical Language ↔ Plain English

Inclusion Criteria: * Best corrected visual acuity 20/40 in each eye * 2 out 5 specified symptoms * Corneal fluorescein staining score greater than or equal to 3 out of 15 Exclusion Criteria: * Unable to stop concomitant medications * Have had intraocular surgery in previous 90 days * Have excluded systemic or ocular disease * Wear contact lenses and are not willing to remove them * Have intraocular pressure greater than 22 mg Hg

Outcomes

Primary Outcomes

Evaluation of adverse events

Ocular symptomatology

Visual acuity

Biomicroscopy

Ophthalmoscopy

Secondary Outcomes

Unanesthetized Schirmer test

Data from ClinicalTrials.gov

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