A Study of INS365 Ophthalmic Solution in Patients With Moderate to Severe Dry Eye Disease

Merck Sharp & Dohme LLC150 enrolled

Overview

To evaluate the efficacy and safety of INS365 Ophthalmic Solution when applied topically in patients with moderate to severe dry eye disease.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

150

Conditions

Dry Eye Disease

Interventions

diquafosol tetrasodium (INS365) ophthalmic solutionDRUG

Eligibility

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Schirmer scores

Corneal staining

Conjunctival staining

Tear break-up time

Change in artificial tear usage

Patient-reported improvement of foreign body sensation

Secondary Outcomes

Visual acuity

Investigator global severity assessment

Patient-reported dry eye symptoms other than foreign body sensation

Biomicroscopy

Ophthalmoscopy

IOP

Data from ClinicalTrials.gov

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