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A Natural History Study of Patients With Dry Eye

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00833235
First Posted: February 2, 2009
Last Update Posted: July 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
  Purpose
This is a multi-center, prospective, controlled, observational study of the natural history of patients with dry eye disease.

Condition Intervention
Dry Eye Other: Artificial Tears

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percentage of Patients with Progression of Dry Eye Disease [ Time Frame: Baseline, 60 Months ]

Secondary Outcome Measures:
  • Change from Baseline in Ocular Surface Disease Index© (OSDI©) Score [ Time Frame: Baseline, 60 Months ]
  • Percentage of Patients with an Increase in Blurred Vision [ Time Frame: Baseline, 60 Months ]
  • Change from Baseline in Schirmer's Test [ Time Frame: Baseline, 60 Months ]
  • Change from Baseline in Conjunctival Staining Score on a 6-Point Scale [ Time Frame: Baseline, 60 Months ]
  • Change from Baseline in Corneal Staining Score on a 6-Point Scale [ Time Frame: Baseline, 60 Months ]

Biospecimen Retention:   Samples With DNA
Tear collection

Enrollment: 284
Actual Study Start Date: February 1, 2009
Study Completion Date: March 6, 2017
Primary Completion Date: March 6, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with dry eye
No treatment is prescribed for the study. Patient dry eye progression will be followed for up to 60 months. Patients may use artificial tears to treat their dry eye symptoms.
Other: Artificial Tears
Artificial tears (any brand) may be used to treat dry eye symptoms.
Patients with no history of dry eye
No treatment is prescribed for this control group. Patients will be followed for up to 60 months. If needed, patients may use artificial tears.
Other: Artificial Tears
Artificial tears (any brand) may be used to treat dry eye symptoms.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 (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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00833235


Locations
United States, Arkansas
Jones Eye Institute
Little Rock, Arkansas, United States, 72205
United States, California
North Valley Eye Medical Group, Inc.
Mission Hills, California, United States, 91345
Milauskas Eye Institute
Rancho Mirage, California, United States, 92270
United States, Colorado
Eye Center of Northern Colorado
Fort Collins, Colorado, United States, 80525
United States, Florida
Cape Coral Eye Center, PA
Cape Coral, Florida, United States, 33904
The Eye Institute of West Florida
Largo, Florida, United States, 33770
United States, Maryland
The Wilmer Eye Institute Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Minnesota
Minnesota Eye Consultants, P.A.
Bloomington, Minnesota, United States, 55431
United States, Missouri
Mulqueeny Eye Centers
Creve Coeur, Missouri, United States, 63141
Mercy Eye Specilaists
Springfield, Missouri, United States, 65804
United States, Ohio
Cleveland Eye Clinic
Brecksville, Ohio, United States, 44141
United States, Pennsylvania
Ophthalmic Partners Bala
Cynwyd, Pennsylvania, United States, 19004
Hazleton Eye Specialists
Township, Pennsylvania, United States, 16066
United States, Tennessee
Vanderbilt Eye Institute
Nashville, Tennessee, United States, 37232
United States, Texas
Alkek Eye Center, Department of Ophthalmology
Houston, Texas, United States, 77030
The Eye Clinic of Texas/ dba Texas Clinical Eye Research Center
League City, Texas, United States, 77573
United States, Virginia
See Clearly Vision Group
McLean, Virginia, United States, 22102
Sponsors and Collaborators
Allergan
Investigators
Study Director: Tes Ignacio Allergan
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00833235     History of Changes
Other Study ID Numbers: MA-RES-08-001
First Submitted: January 30, 2009
First Posted: February 2, 2009
Last Update Posted: July 25, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Lubricant Eye Drops
Ophthalmic Solutions
Pharmaceutical Solutions