A Natural History Study of Patients With Dry Eye

This study is currently recruiting participants.

Verified by Allergan, August 2009

First Received: January 30, 2009 Last Updated: August 11, 2009 History of Changes

Sponsored by:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00833235

Purpose

This is a multi-center, prospective, controlled, observational study of the natural history of patients with dry eye disease.

Condition
Dry Eye

Study Type:	Observational
Study Design:	Case Control, Prospective

Further study details as provided by Allergan:

Primary Outcome Measures:

corneal staining [ Time Frame: Month 6, 12, 18, 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

OSDI [ Time Frame: Month 6, 12, 18, 24 ] [ Designated as safety issue: No ]
Blurred Vision [ Time Frame: Month 6, 12, 18, 24 ] [ Designated as safety issue: No ]
Schirmers Test [ Time Frame: Month 6, 12, 18, 24 ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Tear collection

Estimated Enrollment:	250
Study Start Date:	February 2009
Estimated Study Completion Date:	February 2013
Estimated Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts
A Patients with dry eye
B Patients with no history of dry eye

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

At least 200 dry eye patients (with at least 40% of patients with elevated biomarkers for ocular surface inflammation) will be enrolled at approximately 15-20 sites. Approximately 40-50 patients will be enrolled in the control group.

Criteria

Inclusion Criteria:

Males at least 55 years old or females, at least 40 years old with perimenopausal symptoms
Baseline OSDI score of > 13
Patients with mild to moderate dry eye.

Exclusion Criteria:

Use of any topical cyclosporine ophthalmic emulsion within 3 months of baseline;
History of herpes keratitis or varizella zoster keratitis;
Any history of allergic conjunctivitis;
Temporary or permanent occlusion or cauterization of the lacrimal puncta for either eye.
Any anterior segment surgery involving a limbal or corneal incision (cataract surgery), keratorefractive procedure (LASIK, LASEK, PRK), or expectation of such surgery within 2 years
Patients with known systemic disease
Any history of corneal transplant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00833235

Contacts

Contact: Allergan Inc

clinicaltrials@allergan.com

Locations

United States, Maryland
	Recruiting
Baltimore, Maryland, United States

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Allergan, Inc. ( Vice President Medical Affairs )
Study ID Numbers:	MA-RES-08-001
Study First Received:	January 30, 2009
Last Updated:	August 11, 2009
ClinicalTrials.gov Identifier:	NCT00833235 History of Changes
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 28, 2009