Efficacy Study of Ecabet Ophthalmic Solution in Dry Eye Disease

This study is currently recruiting participants.

Verified by ISTA Pharmaceuticals, April 2008

First Received: April 23, 2008 Last Updated: April 24, 2008 History of Changes

Sponsored by:	ISTA Pharmaceuticals
Information provided by:	ISTA Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00667004

Purpose

Efficacy study of ecabet ophthalmic solution in dry eye disease

Condition	Intervention	Phase
Dry Eye Disease	Drug: ecabet ophthalmic solution Drug: placebo	Phase II

MedlinePlus related topics: Eye Diseases

Drug Information available for: Ecabet

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment

Further study details as provided by ISTA Pharmaceuticals:

Primary Outcome Measures:

Lacrimation assessed by Schirmer's test [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	168
Study Start Date:	April 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental ecabet ophthalmic solution	Drug: ecabet ophthalmic solution sterile ophthalmic solution
2: Placebo Comparator Placebo comparator	Drug: placebo sterile ophthalmic solution

Eligibility

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

Criteria

Inclusion Criteria:

Diagnosed with dry eye disease

Exclusion Criteria:

Dry eye disease secondary to surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667004

Contacts

Contact: Tim McNamara, PharmD

949-788-6000

tmcnamara@istavision.com

Locations

United States, California
ISTA Pharmaceuticals, Inc.	Recruiting
Irvine, California, United States, 92618
Contact: Ralph Bianca, MA, MS, PhD 949-788-6000 rbianca@istavision.com

Sponsors and Collaborators

ISTA Pharmaceuticals

Investigators

Study Director:

Tim McNamara, PharmD

ISTA Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party:	ISTA Pharmaceuticals, Inc. ( Tim McNamara, Vice President Clinical Research & Medical Affairs )
Study ID Numbers:	CL-S&E-1107071-P
Study First Received:	April 23, 2008
Last Updated:	April 24, 2008
ClinicalTrials.gov Identifier:	NCT00667004 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anticarcinogenic Agents
Ecabet
Eye Diseases
Protease Inhibitors

Additional relevant MeSH terms:

Anticarcinogenic Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Eye Diseases
Physiological Effects of Drugs
Gastrointestinal Agents

Enzyme Inhibitors
Protective Agents
Pharmacologic Actions
Protease Inhibitors
Ecabet
Therapeutic Uses
Anti-Ulcer Agents

ClinicalTrials.gov processed this record on May 07, 2009