Study of INS365 Ophthalmic Solution in Subjects With Dry Eye Disease

Phase 3

Completed

• Conditions: Dry Eye Disease

• Registration Number: NCT00404131
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The purpose of this trial is to compare the effectiveness and safety of INS365 Ophthalmic Solution with placebo when applied topically in subjects with dry eye disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-03
• Primary Completion: 2001-12
• Study Completion: 2001-12
• Study First Submitted: 2006-11-22
• Study First Submitted QC: 2006-11-22
• Study First Posted: 2006-11-27
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-28
• Last Update Posted: 2016-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• best corrected visual acuity in both eyes of at least +0.7
• six-month documented history of dry eye disease
• at least mild severity in 2 of the 4 dry eye symptoms
• unanesthetized Schirmer score of less than or equal to 7mm
• corneal fluorescein staining of greater than or equal to 4 (out of 15)

Exclusion Criteria

• nasally stimulated Schirmer score of less than 3mm in subjects with an initial Schirmer score of 0mm
• ongoing contact lens wear
• current topical ophthalmic medication use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in dry eye testing measures and symptoms

Secondary Outcome Measures

Name	Time	Method
Change in dry eye testing measures and symptoms