title: Ocular hypotensive effect of oral palmitoyl-ethanolamide: a clinical trial.
abstract: OBJECTIVE
  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 ± 1.7 mm Hg), IOP was reduced by 3.2 ± 1.3 mm Hg at 1 month and by 3.5 ± 1.2 mm Hg (15.9% ± 5.1%) at 2 months (ANOVA, P < 0.001; both Tukey-Kramer, P < 0.01 vs. baseline); after placebo (mean baseline IOP, 21.5 ± 1.5 mm Hg), IOP was reduced by 0.4 ± 1.2 mm Hg at 1 month and by 0.3 ± 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).
authors.affiliation: Institute of Ophthalmology, University of Catania, Catania, Italy.
authors.forename: Caterina
authors.initials: C
authors.lastname: Gagliano
authors.forename: Elina
authors.initials: E
authors.lastname: Ortisi
authors.forename: Luigi
authors.initials: L
authors.lastname: Pulvirenti
authors.forename: Michele
authors.initials: M
authors.lastname: Reibaldi
authors.forename: Davide
authors.initials: D
authors.lastname: Scollo
authors.forename: Roberta
authors.initials: R
authors.lastname: Amato
authors.forename: Teresio
authors.initials: T
authors.lastname: Avitabile
authors.forename: Antonio
authors.initials: A
authors.lastname: Longo
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000577:Amides; D000959:Antihypertensive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D018592:Cross-Over Studies; D004311:Double-Blind Method; D063388:Endocannabinoids; D004983:Ethanolamines; D005260:Female; D005902:Glaucoma, Open-Angle / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy / Q000503:physiopathology; D010169:Palmitic Acids / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D013607:Tablets; D013999:Timolol / Q000627:therapeutic use; D014792:Visual Acuity / Q000502:physiology; D014794:Visual Fields / Q000502:physiology
chemical_list: D000577:Amides; D000959:Antihypertensive Agents; D063388:Endocannabinoids; D004983:Ethanolamines; D010169:Palmitic Acids; D013607:Tablets; C005958:palmidrol; D013999:Timolol