A Natural History Study of Patients With Dry Eye

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

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Other: Artificial Tears

• Study Type: Observational
• Enrollment (Actual): 284

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Jones Eye Institute
  • California
    • Mission Hills, California, United States, 91345
      • North Valley Eye Medical Group, Inc.
    • Rancho Mirage, California, United States, 92270
      • Milauskas Eye Institute
  • Colorado
    • Fort Collins, Colorado, United States, 80525
      • Eye Center of Northern Colorado
  • Florida
    • Cape Coral, Florida, United States, 33904
      • Cape Coral Eye Center, PA
    • Largo, Florida, United States, 33770
      • The Eye Institute of West Florida
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • The Wilmer Eye Institute Johns Hopkins Hospital
  • Minnesota
    • Bloomington, Minnesota, United States, 55431
      • Minnesota Eye Consultants, P.A.
  • Missouri
    • Creve Coeur, Missouri, United States, 63141
      • Mulqueeny Eye Centers
    • Springfield, Missouri, United States, 65804
      • Mercy Eye Specilaists
  • Ohio
    • Brecksville, Ohio, United States, 44141
      • Cleveland Eye Clinic
  • Pennsylvania
    • Cynwyd, Pennsylvania, United States, 19004
      • Ophthalmic Partners Bala
    • Township, Pennsylvania, United States, 16066
      • Hazleton Eye Specialists
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt Eye Institute
  • Texas
    • Houston, Texas, United States, 77030
      • Alkek Eye Center, Department of Ophthalmology
    • League City, Texas, United States, 77573
      • The Eye Clinic of Texas/ dba Texas Clinical Eye Research Center
  • Virginia
    • McLean, Virginia, United States, 22102
      • See Clearly Vision Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Patients with Progression of Dry Eye Disease	Baseline, 60 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in Ocular Surface Disease Index© (OSDI©) Score	Baseline, 60 Months
Percentage of Patients with an Increase in Blurred Vision	Baseline, 60 Months
Change from Baseline in Schirmer's Test	Baseline, 60 Months
Change from Baseline in Conjunctival Staining Score on a 6-Point Scale	Baseline, 60 Months
Change from Baseline in Corneal Staining Score on a 6-Point Scale	Baseline, 60 Months

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Study Director: Tes Ignacio, Allergan

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2009
• Primary Completion (Actual): March 6, 2017
• Study Completion (Actual): March 6, 2017

Study Registration Dates

• First Submitted: January 30, 2009
• First Submitted That Met QC Criteria: January 30, 2009
• First Posted (Estimate): February 2, 2009

Study Record Updates

• Last Update Posted (Actual): July 25, 2017
• Last Update Submitted That Met QC Criteria: July 22, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Ophthalmic Solutions; Lubricant Eye Drops
• Other Study ID Numbers: MA-RES-08-001