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

BMC Ophthalmology

Research Article

Taryn Conway¹  Linda Villanueva¹  David A. Hollander²  Michael E. Stern³  Stephen C. Pflugfelder⁴  David R. Hardten⁵  Peter J. McDonnell⁶ 

[1] Allergan plc, 2525 Dupont Drive, 92612, Irvine, CA, USA;Allergan plc, 2525 Dupont Drive, 92612, Irvine, CA, USA;Jules Stein Eye Institute, 100 Stein Plaza, University of California, Los Angeles, 90095, Los Angeles, CA, USA;Allergan plc, 2525 Dupont Drive, 92612, Irvine, CA, USA;Present address: 14 Altezza Drive, 92692, Mission Viejo, CA, USA;Baylor Eye Physicians & Surgeons Houston, 6565 Fannin NC 205, 77030, Houston, TX, USA;Minnesota Eye Consultants, 710 E 24th St, 55404-3840, Minneapolis, MN, USA;Wilmer Eye Institute, Johns Hopkins University School of Medicine, 600 N. Wolfe St., Maumenee 727, 21287-0005, Baltimore, MD, USA;

关键词: Dry eye disease;    Natural history;    Tear break-up time;    Cytokines;    Tear film biomarkers;   

DOI  :  10.1186/s12886-017-0646-5

 received in 2016-05-25, accepted in 2017-12-04,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundThe 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.MethodsA 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.ResultsTwo 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 < 0.0001), Schirmer test (5.7 vs 15.3 mm, P < 0.0001), corneal staining (1.4 vs 0.2, P < 0.0001), conjunctival staining (1.4 vs 0.3, P < 0.0001), and tear break-up time (5.7 vs 8.5 s, P < 0.0001). Tear cytokines levels were determined and included interferon-γ, interleukin (IL)-1β, IL-2, IL-4, IL-6, IL-8, tumor necrosis factor-α, epidermal growth factor, IL-13, IL-17, IL-1α, and inducible protein-10. The mean levels of IL-8 and IL-6 were slightly higher in the DED group at baseline. Blurred vision was reported as moderate/severe/very severe at baseline in 57.6% of DED patients vs.10.5% of normal controls (P < 0.0001). DED patients reported greater reductions in work and non-work productivity, as well as greater need for visits to ophthalmologists during the prior year.ConclusionsIn this report of the baseline findings of a 5-year natural history study of DED, a striking disease burden is observed with regard to blurred vision, productivity, and visits to eye care practitioners in mild to moderate DED patients compared to normal subjects of similar ages and genders.Trial registrationClinicalTrials.govNCT00833235 on January 30, 2009.

【 授权许可】

CC BY   
© The Author(s). 2017