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C. Gagliano, A. Longo, E. Ortisi, F. Castiglione, D. Scollo, G. Scollo, T. Avitabile; Ocular Hypotensive Efficacy and Safety of Oral Palmytoilethanolamide (Visimast®): Clinical Study. Invest. Ophthalmol. Vis. Sci. 2010;51(13):988.
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To investigate the role of palmitoylethanolamide (PEA), a cannabimimetic agent known to act in synergy with anandamide (an endogenous agonist of cannabinoid receptor type1-CB1) in reducing IOP in patients with primary open glaucoma (POAG) or ocular hypertension (OHT) maintained in topical anti-hypertensive therapy. Visual acuity, visual field, vital signs, and potential psychotropic effects were secondary outcomes.
Single masked, placebo-controlled, cross-over trial (two separate arms); 42 patients with POAG or OHT treated with topical anti-hypertensive drugs, were randomly assigned to receive either PEA (orally, Visimast® 300 mg) or placebo (Visimast® vehicle) twice daily. IOP value was evaluated at baseline, 30 and 60 days (at 8 am, 12 am, 4 pm and 8 pm). Potential side effects were evaluated. PEA treated patients underwent an untreated washout period of 30 days, after which baseline IOP was measured. Patients were then treated with the opposite dosing regimen for 60 days and IOP measurements were repeated.
On day 30, mean reductions in IOP from baseline were 3.39 ± 0.19 SD mmHg and 1.03±1.1 mmHg for the PEA treated group and placebo group respectively (IC 95%t=7.050 (20 df) P<0.001). On day 60, mean reductions in IOP from baseline were 3.41±0.21 mmHg and 0.02 ± SD 0.25 mmHg for the PEA treated group and placebo group respectively (IC 95% t=6.120 (20 df) P<0.001). Vital signs, visual acuity and visual field were not significantly changed. No adverse events or side effects were reported in both groups.
POAG or OHT patients under treatment with topical anti-hypertensive drugs had a further significant decrease in IOP after 30 and 60 day-treatment with Visimast® (PEA, 300 mg tablet) twice daily, in comparison with the same group of patients likewise treated with topical drugs and placebo. PEA was well tolerated and safe. No side effects were reported in PEA treated group.
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