April 2009
Volume 50, Issue 13
Free
ARVO Annual Meeting Abstract  |   April 2009
Efficacy and Safety of PF-03187207, A Novel Nitric Oxide Donating Prostaglandin F2-Alpha Analogue, vs. Latanoprost in Hypertensive Eyes
Author Affiliations & Notes
  • C. F. Bosworth
    Clinical Develop Ophthal, Pfizer Inc, San Diego, California
  • M. Zhang
    Clinical Develop Ophthal, Pfizer Inc, San Diego, California
  • R. Courtney
    Clinical Develop Ophthal, Pfizer Inc, San Diego, California
  • S. Raber
    Clinical Develop Ophthal, Pfizer Inc, San Diego, California
  • D. Eveleth
    Clinical Develop Ophthal, Pfizer Inc, San Diego, California
  • M. Beekman
    Clinical Develop, NicOx SA, Sophia Antipolis, France
  • Footnotes
    Commercial Relationships  C.F. Bosworth, Pfizer Inc., E; M. Zhang, Pfizer Inc., E; R. Courtney, Pfizer Inc., E; S. Raber, Pfizer Inc., E; D. Eveleth, Pfizer Inc., E; M. Beekman, NicOx SA, E.
  • Footnotes
    Support  None.
Investigative Ophthalmology & Visual Science April 2009, Vol.50, 2481. doi:
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      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.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: : 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.

Methods: : 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.

Results: : 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.

Conclusions: : 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: : www.clinicaltrials.gov NCT00595101

Keywords: intraocular pressure • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • nitric oxide 
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