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

A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Dose-Ranging Study of Multiple Ocular Instillations of INS365 Ophthalmic Solution vs. Placebo in Patients With Moderate to Severe Dry Eye Disease

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

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.