Study design and baseline findings from the progression of ocular findings (PROOF) natural history study of dry eye

The aim of this research is to initiate a 5-year natural history study of dry eye disease (DED) using objectively assessed and patient-reported outcomes, to explore the hypothesis that DED is a progressive condition that has substantive and measurable impacts not only on the ocular surface, but on q...

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Bibliographic Details
Published in:BMC ophthalmology 2017-12, Vol.17 (1), p.265-265, Article 265
Main Authors: McDonnell, Peter J, Pflugfelder, Stephen C, Stern, Michael E, Hardten, David R, Conway, Taryn, Villanueva, Linda, Hollander, David A
Format: Article
Language:English
Subjects:
Biological response modifiers
Cytokines
Dry eye disease
Epidermal growth factors
Eye diseases
Interferon
Interleukins
Medical research
Natural history
Ophthalmic agents
Ophthalmology
Task forces
Tear break-up time
Tear film biomarkers
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Summary:The aim of this research is to initiate a 5-year natural history study of dry eye disease (DED) using objectively assessed and patient-reported outcomes, to explore the hypothesis that DED is a progressive condition that has substantive and measurable impacts not only on the ocular surface, but on quality of life and visual functioning. Our objective for this report is to examine the baseline data. A multicenter, prospective, controlled, observational study of Level 2 (mild-to-moderate) DED patients based on International Task Force Delphi Panel severity grading, and controls, documented baseline measures (including tear film biomarkers and quality of life). Tear cytokine concentrations were also measured in the tear film. Patients were using artificial tears as needed. Two hundred seventeen DED patients and 67 gender- and age-matched controls were enrolled. A majority were females and Caucasian and groups did not differ significantly in terms of gender, race, or age. Differences between DED and matched controls, at baseline, included mean scores for Ocular Surface Disease Index (31.7 vs 4.1, P 
ISSN:1471-2415
1471-2415
DOI:10.1186/s12886-017-0646-5