Study of INS365 Ophthalmic Solution in Subjects With Dry Eye Disease

• Sponsor: Merck Sharp & Dohme LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00403715
• Collaborator: (none)
• Enrollment: 500
• Duration (Months): 19

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Disease	Drug: diquafosol tetrasodium (INS365) Ophthalmic Solution	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 500 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Dose-Ranging Study of Multiple Ocular Instillations of INS365 Ophthalmic Solution vs. Placebo in Subjects With Dry Eye Disease
• Study Start Date: Feb 1, 2001
• Actual Primary Completion Date: Sep 1, 2002
• Actual Study Completion Date: Sep 1, 2002

Outcome Measures

Primary Outcome Measures

1. change in dry eye testing measures and symptoms []

Secondary Outcome Measures

1. change in dry eye testing measures and symptoms []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Merck Sharp & Dohme LLC

Investigators

• Study Director: Amy Schaberg, BSN,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Merck Sharp & Dohme LLC
• ClinicalTrials.gov Identifier: NCT00403715
• Other Study ID Numbers: 03-104
• First Posted: Nov 27, 2006
• Last Update Posted: Nov 29, 2016
• Last Verified: Nov 1, 2016

• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases; Ophthalmic Solutions

Study Results

No Results Posted as of Nov 29, 2016