The safety and efficacy of palmitoylethanolamide (PEA) was explored in reducing Intra Ocular Pressure in patients with primary open glaucoma (POAG) or ocular hypertension (OHT) maintained in topical anti-hypertensive therapy.
In a single blinded, placebo-controlled, cross-over trial 42 patients with h primary open glaucoma (POAG) or r ocular hypertension (OHT) are which were treated with topical anti-hypertensive drugs, were randomly trated either with PEA or placebo.
IOP value was evaluated at baseline, 30 and 60 days.PEA treated patients underwent an untreated washout period of 30 days, after which baseline IOP was measured.
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 PEA, 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.
Source: 988 – A345
Ocular Hypotensive Efficacy and Safety of Oral Palmytoilethanolamide, C. Gagliano et al, 2010, the Association for Research in Vision and Ophthalmology