Purchase this article with an account.
C. F. Bosworth, M. Zhang, R. Courtney, S. Raber, D. Eveleth, M. Beekman; Efficacy and Safety of PF-03187207, A Novel Nitric Oxide Donating Prostaglandin F2-Alpha Analogue, vs. Latanoprost in Hypertensive Eyes. Invest. Ophthalmol. Vis. Sci. 2009;50(13):2481.
Download citation file:
© ARVO (1962-2015); The Authors (2016-present)
To determine if any single concentration of PF-03187207 (PF-207) is superior to PM dosing of latanoprost (Lat) 0.005% ophthalmic solution for the reduction of elevated diurnal IOP.
This trial was an adaptive dose-ranging, randomized, double-masked, 28-day, parallel-group, multi-center study in adult subjects with primary open-angle glaucoma (POAG) or ocular hypertension (OH). Five concentrations of PF-207 ranging from 0.003% to 0.04% were evaluated; groups included in the combined Stage I and II analysis were: 1) PF-207 0.024% AM, Lat vehicle PM, 2) PF-207 0.04% AM, Lat vehicle PM, 3) PF-207 0.04% PM, Lat vehicle AM, 4) Lat AM, PF-207 vehicle PM, and 5) Lat PM, PF-207 vehicle AM. IOP was measured at screening and at 8AM, 10AM, 1PM and 4PM on Eligibility 1, Eligibility 2 (Day 0), Day 7, 14, 21 and 28.
176 subjects were randomized to the Stage I and II dose groups; 104 (59.1%) were diagnosed as POAG, 72 (40.9%) were diagnosed as OH, and 154 (87.5%) completed the protocol as planned. Per-protocol efficacy results are summarized in Table 1. Conjunctival hyperaemia and eye irritation were the most common ocular AEs reported (≥3% of subjects). AE rates were similar across treatment groups.
While no single concentration of PF-207 was significantly superior to PM dosing of Lat for the reduction of elevated diurnal IOP at Day 28, the greatest IOP reduction was consistently observed in the PF-207 0.04% PM group. PF-207 was found to be safe and well tolerated at concentrations up to and including 0.04%.
Clinical Trial: :
This PDF is available to Subscribers Only