Clinical trial NCT00833235: A Natural History Study of Patients With Dry Eye
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2009-02-02
Enrollment: 284
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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


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

Primary outcomes:
measure: Percentage of Patients with Progression of Dry Eye Disease
timeFrame: Baseline, 60 Months
Secondary outcomes:
measure: Change from Baseline in Ocular Surface Disease Index© (OSDI©) Score
timeFrame: Baseline, 60 Months
measure: Percentage of Patients with an Increase in Blurred Vision
timeFrame: Baseline, 60 Months
measure: Change from Baseline in Schirmer's Test
timeFrame: Baseline, 60 Months
measure: Change from Baseline in Conjunctival Staining Score on a 6-Point Scale
timeFrame: Baseline, 60 Months
measure: Change from Baseline in Corneal Staining Score on a 6-Point Scale
timeFrame: Baseline, 60 Months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Jones Eye Institute
state: Arkansas
city: Mission Hills
country: United States
facility: North Valley Eye Medical Group, Inc.
state: California
city: Rancho Mirage
country: United States
facility: Milauskas Eye Institute
state: California
city: Fort Collins
country: United States
facility: Eye Center of Northern Colorado
state: Colorado
city: Cape Coral
country: United States
facility: Cape Coral Eye Center, PA
state: Florida
city: Largo
country: United States
facility: The Eye Institute of West Florida
state: Florida
city: Baltimore
country: United States
facility: The Wilmer Eye Institute Johns Hopkins Hospital
state: Maryland
city: Bloomington
country: United States
facility: Minnesota Eye Consultants, P.A.
state: Minnesota
city: Creve Coeur
country: United States
facility: Mulqueeny Eye Centers
state: Missouri
city: Springfield
country: United States
facility: Mercy Eye Specilaists
state: Missouri
city: Brecksville
country: United States
facility: Cleveland Eye Clinic
state: Ohio
city: Cynwyd
country: United States
facility: Ophthalmic Partners Bala
state: Pennsylvania
city: Township
country: United States
facility: Hazleton Eye Specialists
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Eye Institute
state: Tennessee
city: Houston
country: United States
facility: Alkek Eye Center, Department of Ophthalmology
state: Texas
city: League City
country: United States
facility: The Eye Clinic of Texas/ dba Texas Clinical Eye Research Center
state: Texas
city: McLean
country: United States
facility: See Clearly Vision Group
state: Virginia
Study officials:
affiliation: Allergan
name: Tes Ignacio
role: STUDY_DIRECTOR
References:
citation: 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.