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Trial record 1 of 1 for:    NCT00833235 | United States
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A Natural History Study of Patients With Dry Eye

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ClinicalTrials.gov Identifier: NCT00833235
Recruitment Status : Completed
First Posted : February 2, 2009
Last Update Posted : July 25, 2017
Sponsor:
Information provided by (Responsible Party):
Allergan

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

Condition or disease Intervention/treatment
Dry Eye Other: Artificial Tears

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Study Type : Observational
Actual Enrollment : 284 participants
Observational Model: Case-Control
Time Perspective: Prospective
Actual Study Start Date : February 1, 2009
Actual Primary Completion Date : March 6, 2017
Actual Study Completion Date : March 6, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Group/Cohort Intervention/treatment
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.




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

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

Biospecimen Retention:   Samples With DNA
Tear collection


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.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
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

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
Show Show 17 study locations
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Tes Ignacio Allergan
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00833235    
Other Study ID Numbers: MA-RES-08-001
First Posted: February 2, 2009    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Lubricant Eye Drops
Ophthalmic Solutions
Pharmaceutical Solutions