A Natural History Study of Patients With Dry Eye

• ClinicalTrials.gov Identifier: NCT00833235
• Recruitment Status: Completed
• First Posted: February 2, 2009
• Last Update Posted: July 25, 2017
• Sponsor: Allergan
• 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 ]

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.

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

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