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Peter McDonnell, Steve Pflugfelder, Rhett Schiffman, David Hardten, Michael Stern, Taryn Conway, David Hollander; Progression of Ocular Findings (PROOF) Study of the Natural History of Dry Eye: Study Design and Baseline Patient Characteristics. Invest. Ophthalmol. Vis. Sci. 2013;54(15):4338.
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The natural history of a disease is an important consideration when choosing a disease management strategy. A natural history study is in progress (PROOF, Progression of Ocular Findings) to determine the rate of progression of dry eye disease in patients with moderate dry eye. This presentation describes the study design and the baseline characteristics of study participants.
This multicenter, prospective, 5-year, observational, case-controlled study enrolled patients with Level 2 dry eye based on International Task Force (ITF) criteria (dry eye group) and patients with no history of dry eye (control group). Primary exclusion criteria included use of topical cyclosporine emulsion within 3 months prior to baseline, ocular surgery or use of punctal plugs, topical steroids, topical NSAIDs, or oral tetracyclines within 12 months prior to baseline, and any planned use of these treatments or surgery during the study. Subjects were permitted to administer artificial tears as needed. Patients are being followed every 6 months with evaluations including Schirmer tests, tear break-up time (TBUT), Ocular Surface Disease Index (OSDI), corneal and conjunctival staining (Oxford and NEI), and goblet cell density. The primary study endpoint is the percentage of patients with progression of dry eye disease from baseline to month 60.
Two hundred sixty-eight participants (217 dry eye patients and 51 control subjects) were enrolled. The mean age was 63.1 years in the dry eye group and 59.0 years in the control group. Differences between the dry eye and control groups at baseline included mean OSDI scores (31.5 vs 5.0, P<.001); mean Schirmer test values (5.7 mm vs 14.9 mm, P<.001); mean scores of corneal staining (1.4 vs 0.18, P<.001) and conjunctival staining (1.40 vs 0.29, P<.001); mean TBUT (5.7 s vs 8.7 s, P<.001); and mean temporal goblet cell density (54.5 cells/mm2 vs 90.4 cells/mm2, P=.035). Moderate, severe, or very severe blurred vision was reported at baseline in 58.5% of dry eye patients vs 13.7% of control subjects (P<.001).
PROOF is an ongoing, observational, natural history study in patients with Level 2 dry eye. Decreases in goblet cell density and increases in blurred vision are evident in dry eye disease as early as disease severity Level 2.
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