A Natural History Study of Patients With Dry Eye

Dry Eye Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00833235
• Other study ID #: MA-RES-08-001
• Status: Completed
• Phase: N/A
• First received: January 30, 2009
• Last updated: July 22, 2017
• Start date: February 1, 2009
• Est. completion date: March 6, 2017

Study information

• Verified date: July 2017
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: March 6, 2017
• Est. primary completion date: March 6, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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 (dry eye disease patients only; not applicable for control group)

Exclusion Criteria:

• Use of any topical cyclosporine ophthalmic emulsion within 3 months of baseline

• History of herpes keratitis or varicella 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) within 12 months of baseline, or expectation of such surgery within 2 years

• Patients with known systemic disease

• Any history of corneal transplant

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Other:
• Artificial Tears
Artificial tears (any brand) may be used to treat dry eye symptoms.

Locations

Country	Name	City	State
United States	The Wilmer Eye Institute Johns Hopkins Hospital	Baltimore	Maryland
United States	Minnesota Eye Consultants, P.A.	Bloomington	Minnesota
United States	Cleveland Eye Clinic	Brecksville	Ohio
United States	Cape Coral Eye Center, PA	Cape Coral	Florida
United States	Mulqueeny Eye Centers	Creve Coeur	Missouri
United States	Ophthalmic Partners Bala	Cynwyd	Pennsylvania
United States	Eye Center of Northern Colorado	Fort Collins	Colorado
United States	Alkek Eye Center, Department of Ophthalmology	Houston	Texas
United States	The Eye Institute of West Florida	Largo	Florida
United States	The Eye Clinic of Texas/ dba Texas Clinical Eye Research Center	League City	Texas
United States	Jones Eye Institute	Little Rock	Arkansas
United States	See Clearly Vision Group	McLean	Virginia
United States	North Valley Eye Medical Group, Inc.	Mission Hills	California
United States	Vanderbilt Eye Institute	Nashville	Tennessee
United States	Milauskas Eye Institute	Rancho Mirage	California
United States	Mercy Eye Specilaists	Springfield	Missouri
United States	Hazleton Eye Specialists	Township	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients with Progression of Dry Eye Disease		Baseline, 60 Months
Secondary	Change from Baseline in Ocular Surface Disease Index© (OSDI©) Score		Baseline, 60 Months
Secondary	Percentage of Patients with an Increase in Blurred Vision		Baseline, 60 Months
Secondary	Change from Baseline in Schirmer's Test		Baseline, 60 Months
Secondary	Change from Baseline in Conjunctival Staining Score on a 6-Point Scale		Baseline, 60 Months
Secondary	Change from Baseline in Corneal Staining Score on a 6-Point Scale		Baseline, 60 Months