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

Phase 3

Completed

• Conditions: Keratoconjunctivitis Sicca

• Registration Number: NCT00037661
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Study First Submitted: 2002-05-18
• Study First Submitted QC: 2002-05-19
• Study First Posted: 2002-05-20
• Primary Completion: 2003-03
• Study Completion: 2003-03
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-01
• Last Update Posted: 2015-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 222

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL