A Natural History Study of Patients With Dry Eye
1 other identifier
observational
284
1 country
17
Brief Summary
This is a multi-center, prospective, controlled, observational study of the natural history of patients with dry eye disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2009
Longer than P75 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2009
CompletedStudy Start
First participant enrolled
February 1, 2009
CompletedFirst Posted
Study publicly available on registry
February 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 6, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 6, 2017
CompletedJuly 25, 2017
July 1, 2017
8.1 years
January 30, 2009
July 22, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Patients with Progression of Dry Eye Disease
Baseline, 60 Months
Secondary Outcomes (5)
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
Study Arms (2)
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.
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.
Interventions
Artificial tears (any brand) may be used to treat dry eye symptoms.
Eligibility Criteria
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.
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (17)
Jones Eye Institute
Little Rock, Arkansas, 72205, United States
North Valley Eye Medical Group, Inc.
Mission Hills, California, 91345, United States
Milauskas Eye Institute
Rancho Mirage, California, 92270, United States
Eye Center of Northern Colorado
Fort Collins, Colorado, 80525, United States
Cape Coral Eye Center, PA
Cape Coral, Florida, 33904, United States
The Eye Institute of West Florida
Largo, Florida, 33770, United States
The Wilmer Eye Institute Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Minnesota Eye Consultants, P.A.
Bloomington, Minnesota, 55431, United States
Mulqueeny Eye Centers
Creve Coeur, Missouri, 63141, United States
Mercy Eye Specilaists
Springfield, Missouri, 65804, United States
Cleveland Eye Clinic
Brecksville, Ohio, 44141, United States
Ophthalmic Partners Bala
Cynwyd, Pennsylvania, 19004, United States
Hazleton Eye Specialists
Township, Pennsylvania, 16066, United States
Vanderbilt Eye Institute
Nashville, Tennessee, 37232, United States
Alkek Eye Center, Department of Ophthalmology
Houston, Texas, 77030, United States
The Eye Clinic of Texas/ dba Texas Clinical Eye Research Center
League City, Texas, 77573, United States
See Clearly Vision Group
McLean, Virginia, 22102, United States
Related Publications (1)
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.
PMID: 29284427DERIVED
Biospecimen
Tear collection
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tes Ignacio
Allergan
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2009
First Posted
February 2, 2009
Study Start
February 1, 2009
Primary Completion
March 6, 2017
Study Completion
March 6, 2017
Last Updated
July 25, 2017
Record last verified: 2017-07