Study of INS365 Ophthalmic Solution in Subjects With Dry Eye Disease

This study has been completed.

Sponsored by:	Inspire Pharmaceuticals
Information provided by:	Inspire Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00404131

Purpose

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	Intervention	Phase
Dry Eye Disease	Drug: diquafosol tetrasodium (INS365) Ophthalmic Solution	Phase III

MedlinePlus related topics: Eye Diseases

Drug Information available for: Diquafosol Ins 365

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Inspire Pharmaceuticals:

Primary Outcome Measures:

Change in dry eye testing measures and symptoms

Secondary Outcome Measures:

Change in dry eye testing measures and symptoms

Estimated Enrollment:	500
Study Start Date:	March 2001

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404131

Locations

United States, Minnesota
Northwest Eye Clinic
Minneapolis, Minnesota, United States, 55421

Sponsors and Collaborators

Inspire Pharmaceuticals

Investigators

Study Director:

Amy Schaberg, BSN

More Information

Study ID Numbers:	03-105
Study First Received:	November 22, 2006
Last Updated:	November 22, 2006
ClinicalTrials.gov Identifier:	NCT00404131
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Eye Diseases

ClinicalTrials.gov processed this record on January 14, 2009