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PURPOSE. To investigate the effect of oral palmitoyl-ethanolamide (PEA) on intraocular pressure (IOP) in primary open angle glaucoma (POAG) and ocular hypertension (OH). METHODS. In a prospective, randomized, double-blind, crossover clinical trial, 42 patients with POAG or OH who were treated with timolol 0.5% and whose IOP was between 19 and 24 mm Hg received oral PEA (300-mg tablets twice a day) or placebo (PEA vehicle tablets twice a day) for 2 months (period 1), and, after a 2-month washout, received the other treatment for 1 month (period 2). IOP, best-corrected visual acuity, and visual field parameters were considered. RESULTS. After PEA treatment (mean baseline IOP, 21.6 (plus or minus) 1.7 mm Hg), IOP was reduced by 3.2 (plus or minus) 1.3 mm Hg at 1 month and by 3.5 (plus or minus) 1.2 mm Hg (15.9% (plus or minus) 5.1%) at 2 months (ANOVA, P < 0.001; both Tukey-Kramer, P < 0.01 vs. baseline); after placebo (mean baseline IOP, 21.5 (plus or minus) 1.5 mm Hg), IOP was reduced by 0.4 (plus or minus) 1.2 mm Hg at 1 month and by 0.3 (plus or minus) 1.3 mm Hg at 2 months (t-test at both time points, P < 0.001 vs. PEA). No statistically significant vital signs, visual field, visual acuity changes, or adverse events were detected in either group. CONCLUSIONS. Systemic administration of PEA reduces IOP in patients with glaucoma and ocular hypertension. PEA could be a valuable tool for the treatment of glaucoma (http://www.umin.ac.jp/ctr/index/htm number, UMIN000002833).
A. Longo. Institute of Ophthalmology, University of Catania, Via Santa Sofia 78, Catania 95123, Italy.
11.14 Investigational drugs; pharmacological experiments (Part of: 11 Medical treatment)