Study of INS365 Ophthalmic Solution in a Controlled Adverse Environment in Patients With Dry Eye

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Keratoconjunctivitis Sicca

Treatments: Drug: INS365 Ophthalmic Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00037661

03-108

Details and patient eligibility

About

Comparative efficacy trial of INS365 Ophthalmic Solution and placebo in patients with dry eye.

Enrollment: 222 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• have Non-Sjogren's associated dry eye disease with symptoms lasting greater than 6 months
• had intermittent or regular artificial tear use within past 3 months

Exclusion criteria

• had LASIK surgery
• had punctal occlusion or cauterization within last 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind