Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
284 participants
OBSERVATIONAL
2009-02-01
2017-03-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
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.
Artificial Tears
Artificial tears (any brand) may be used to treat dry eye symptoms.
Interventions
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Artificial Tears
Artificial tears (any brand) may be used to treat dry eye symptoms.
Eligibility Criteria
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Inclusion Criteria
* Baseline OSDI score of ≥ 13
* Patients with mild to moderate dry eye (dry eye disease patients only; not applicable for control group)
Exclusion Criteria
* 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
40 Years
ALL
Yes
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Tes Ignacio
Role: STUDY_DIRECTOR
Allergan
Locations
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Jones Eye Institute
Little Rock, Arkansas, United States
North Valley Eye Medical Group, Inc.
Mission Hills, California, United States
Milauskas Eye Institute
Rancho Mirage, California, United States
Eye Center of Northern Colorado
Fort Collins, Colorado, United States
Cape Coral Eye Center, PA
Cape Coral, Florida, United States
The Eye Institute of West Florida
Largo, Florida, United States
The Wilmer Eye Institute Johns Hopkins Hospital
Baltimore, Maryland, United States
Minnesota Eye Consultants, P.A.
Bloomington, Minnesota, United States
Mulqueeny Eye Centers
Creve Coeur, Missouri, United States
Mercy Eye Specilaists
Springfield, Missouri, United States
Cleveland Eye Clinic
Brecksville, Ohio, United States
Ophthalmic Partners Bala
Cynwyd, Pennsylvania, United States
Hazleton Eye Specialists
Township, Pennsylvania, United States
Vanderbilt Eye Institute
Nashville, Tennessee, United States
Alkek Eye Center, Department of Ophthalmology
Houston, Texas, United States
The Eye Clinic of Texas/ dba Texas Clinical Eye Research Center
League City, Texas, United States
See Clearly Vision Group
McLean, Virginia, United States
Countries
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References
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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.
Other Identifiers
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MA-RES-08-001
Identifier Type: -
Identifier Source: org_study_id
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