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Ocular hypotensive effect of the novel EP3/FP agonist ONO-9054 versus Xalatan: results of a 28-day, double-masked, randomised study.

ABSTRACT: BACKGROUND/AIMS:ONO-9054 is being developed for the reduction of intraocular pressure (IOP) in patients with ocular hypertension (OHT) and open-angle glaucoma (OAG). This study compared the novel dual EP3/FP agonist ONO-9054 with the FP agonist Xalatan. METHODS:Adults (n=123) with bilateral mild/moderate OAG or OHT, with unmedicated IOP of ?24?mm?Hg at 8:00 hours, ?21?mm?Hg at 10:00 hours and ?36?mm?Hg, were randomised 1:1 to receive ONO-9054 (0.003%, 30??g/mL) or Xalatan (0.005%, 50??g/mL) once daily for 28?days. RESULTS:Day 29 mean diurnal IOP was -7.2?mm?Hg for ONO-9054 vs -6.6?mm?Hg for Xalatan. At 08:00?hours, the IOPs were comparable, and at all later time points the decrease in IOP was greater for ONO-9054. On day 29, the odds of a mean IOP reduction of ?-25%, ?-30% and ?-35% for ONO-9054 were 2.39, 2.37 and 4.85 times more, respectively, than the odds for Xalatan (p<0.05, post hoc analyses). The percentage of subjects achieving target IOPs on day 29 (?17, ?16 and ?15?mm?Hg) was greater for ONO-9054 than for Xalatan; the odds of achieving an IOP ?15?mm?Hg for ONO-9054 were 2.4 times more than the odds for Xalatan (p<0.01, post hoc analysis). CONCLUSIONS:Subjects randomised to receive ONO-9054 were more likely to achieve a greater per cent reduction in IOP and were more likely to achieve target IOPs than those receiving Xalatan. The effects of ONO-9054 in reducing IOP appear to persist longer than those of Xalatan. TRIAL REGISTRATION NUMBER:NCT02083289, Results.

SUBMITTER: Miller Ellis E

PROVIDER: S-EPMC5583686 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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Ocular hypotensive effect of the novel EP3/FP agonist ONO-9054 versus Xalatan: results of a 28-day, double-masked, randomised study.

Miller Ellis Eydie E Berlin Michael S MS Ward Caroline L CL Sharpe John A JA Jamil Alam A Harris Alon A

The British journal of ophthalmology 20160920 6

<h4>Background/aims</h4>ONO-9054 is being developed for the reduction of intraocular pressure (IOP) in patients with ocular hypertension (OHT) and open-angle glaucoma (OAG). This study compared the novel dual EP3/FP agonist ONO-9054 with the FP agonist Xalatan.<h4>Methods</h4>Adults (n=123) with bilateral mild/moderate OAG or OHT, with unmedicated IOP of ≥24 mm Hg at 8:00 hours, ≥21 mm Hg at 10:00 hours and ≤36 mm Hg, were randomised 1:1 to receive ONO-9054 (0.003%, 30 μg/mL) or Xalatan (0.005%, ...[more]

PMID: 27649982

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Dataset Information

Ocular hypotensive effect of the novel EP3/FP agonist ONO-9054 versus Xalatan: results of a 28-day, double-masked, randomised study.

Publications

Ocular hypotensive effect of the novel EP3/FP agonist ONO-9054 versus Xalatan: results of a 28-day, double-masked, randomised study.

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