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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

January 30, 2009
February 2, 2009
July 25, 2017
February 1, 2009
March 6, 2017   (Final data collection date for primary outcome measure)
Percentage of Patients with Progression of Dry Eye Disease [ Time Frame: Baseline, 60 Months ]
corneal staining [ Time Frame: Month 6, 12, 18, 24 ]
Complete list of historical versions of study NCT00833235 on ClinicalTrials.gov Archive Site
  • 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 ]
  • OSDI [ Time Frame: Month 6, 12, 18, 24 ]
  • Blurred Vision [ Time Frame: Month 6, 12, 18, 24 ]
  • Schirmers Test [ Time Frame: Month 6, 12, 18, 24 ]
Not Provided
Not Provided
 
A Natural History Study of Patients With Dry Eye
Not Provided
This is a multi-center, prospective, controlled, observational study of the natural history of patients with dry eye disease.
Not Provided
Observational
Observational Model: Case-Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Tear collection
Probability Sample
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.
Dry Eye
Other: Artificial Tears
Artificial tears (any brand) may be used to treat dry eye symptoms.
  • 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.
    Intervention: Other: Artificial Tears
  • 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.
    Intervention: Other: Artificial Tears
McDonnell PJ, Pflugfelder SC, Stern ME, Hardten DR, Conway T, Villanueva L, Hollander DA. Study design and baseline findings from the progression of ocular findings (PROOF) natural history study of dry eye. BMC Ophthalmol. 2017 Dec 28;17(1):265. doi: 10.1186/s12886-017-0646-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
284
250
March 6, 2017
March 6, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00833235
MA-RES-08-001
No
Not Provided
Not Provided
Allergan
Allergan
Not Provided
Study Director: Tes Ignacio Allergan
Allergan
July 2017