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A Natural History Study of Patients With Dry Eye

This study is currently recruiting participants.
Verified April 2013 by Allergan
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00833235
First received: January 30, 2009
Last updated: April 1, 2013
Last verified: April 2013
History of Changes
  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:

MedlinePlus related topics: Eye Diseases
U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percentage of Patients with Progression of Dry Eye Disease [ Time Frame: Baseline, 60 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in Ocular Surface Disease Index© (OSDI©) Score [ Time Frame: Baseline, 60 Months ] [ Designated as safety issue: No ]
  • Percentage of Patients with an Increase in Blurred Vision [ Time Frame: Baseline, 60 Months ] [ Designated as safety issue: No ]
  • Change from Baseline in Schirmer's Test [ Time Frame: Baseline, 60 Months ] [ Designated as safety issue: No ]
  • Change from Baseline in Conjunctival Staining Score on a 6-Point Scale [ Time Frame: Baseline, 60 Months ] [ Designated as safety issue: No ]
  • Change from Baseline in Corneal Staining Score on a 6-Point Scale [ Time Frame: Baseline, 60 Months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Tear collection


Estimated Enrollment: 250
Study Start Date: February 2009
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (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

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 (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
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
ClinicalTrials.gov Identifier: NCT00833235     History of Changes
Other Study ID Numbers: MA-RES-08-001
Study First Received: January 30, 2009
Last Updated: April 1, 2013
Health Authority: United States: Institutional Review Board

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 May 21, 2013