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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Dry Eye Disease

Treatments: Drug: diquafosol tetrasodium (INS365) ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00679718

03-103

Details and patient eligibility

About

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

Enrollment: 150 estimated patients

Sex

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind