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

This study has been completed.

First Received on May 18, 2002. Last Updated on October 1, 2008 History of Changes

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00037661

Purpose

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

Condition	Intervention	Phase
Keratoconjunctivitis Sicca	Drug: INS365 Ophthalmic Solution	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Double-Masked, Randomized, Placebo-Controlled Study of Efficacy Parameter Following Administration of INS365 Ophthalmic Solution or Placebo in a Controlled Adverse Environment (CAE) Chamber in Subjects With Non-Sjogren's Associated Dry Eye

Resource links provided by NLM:

Drug Information available for: Diquafosol Ins 365

U.S. FDA Resources

Further study details as provided by Merck:

Estimated Enrollment:	200
Study Start Date:	April 2002
Estimated Study Completion Date:	March 2003

Eligibility

Criteria

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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00037661

Locations

United States, Massachusetts
Ophthalmic Research Associates, Inc.
Andover, Massachusetts, United States, 01810

Sponsors and Collaborators

Merck

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00037661 History of Changes
Other Study ID Numbers:	03-108
Study First Received:	May 18, 2002
Last Updated:	October 1, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

dry eye

Additional relevant MeSH terms:

Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases

Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on February 12, 2012