Study of INS365 Ophthalmic Solution in Subjects With Dry Eye Disease

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00404131

First received: November 22, 2006

Last updated: NA

Last verified: November 2006

History: No changes posted

Tracking Information

First Received Date ^ICMJE

November 22, 2006

Last Updated Date

November 22, 2006

Start Date ^ICMJE

March 2001

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Change in dry eye testing measures and symptoms

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Change in dry eye testing measures and symptoms

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study of INS365 Ophthalmic Solution in Subjects With Dry Eye Disease

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Dry Eye Disease

Intervention ^ICMJE

Drug: diquafosol tetrasodium (INS365) Ophthalmic Solution

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

500

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00404131

Other Study ID Numbers ^ICMJE

03-105

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Amy Schaberg, BSN

Information Provided By

Merck

Verification Date

November 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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