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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

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.
 
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

Tracking Information
First Submitted Date January 30, 2009
First Posted Date February 2, 2009
Last Update Posted Date July 25, 2017
Actual Study Start Date February 1, 2009
Actual Primary Completion Date March 6, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 1, 2012)
Percentage of Patients with Progression of Dry Eye Disease [ Time Frame: Baseline, 60 Months ]
Original Primary Outcome Measures
 (submitted: January 30, 2009)
corneal staining [ Time Frame: Month 6, 12, 18, 24 ]
Change History
Current Secondary Outcome Measures
 (submitted: October 1, 2012)
  • 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 ]
Original Secondary Outcome Measures
 (submitted: January 30, 2009)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Natural History Study of Patients With Dry Eye
Official Title Not Provided
Brief Summary This is a multi-center, prospective, controlled, observational study of the natural history of patients with dry eye disease.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Tear collection
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.
Condition Dry Eye
Intervention Other: Artificial Tears
Artificial tears (any brand) may be used to treat dry eye symptoms.
Study Groups/Cohorts
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 27, 2014)
284
Original Estimated Enrollment
 (submitted: January 30, 2009)
250
Actual Study Completion Date March 6, 2017
Actual Primary Completion Date March 6, 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00833235
Other Study ID Numbers MA-RES-08-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Allergan
Study Sponsor Allergan
Collaborators Not Provided
Investigators
Study Director: Tes Ignacio Allergan
PRS Account Allergan
Verification Date July 2017