Single and Multiple Dose Escalation and Two-sequence Crossover Study of ONO-9054 in Patients With Ocular Hypertension or Mild Open-angle Glaucoma

Summary

The primary objective of this study is to evaluate the safety and tolerability of 3 planned doses of ONO-9054 in the eyes of adult male and female patients with ocular hypertension (OHT) or mild open angle-glaucoma (OAG). The secondary objectives are to evaluate Pharmacodynamics (PD) and to characterize the pharmacokinetic (PK) profile of ONO-9054 and its metabolite in plasma and to compare its tolerability following morning and evening dosing.

Timeline

Start

2012-08

Primary completion

2013-05

Completion

—

Publications

• Berlin MS, Rowe-Rendleman C, Ahmed I, Ross DT, Fujii A, Ouchi T, Quach C, Wood A, Ward CL. EP3/FP dual receptor agonist ONO-9054 administered morning or evening to patients with open-angle glaucoma or ocular hypertension: results of a randomised crossover study. Br J Ophthalmol. 2016 Jun;100(6):843-7. doi: 10.1136/bjophthalmol-2015-307000. Epub 2015 Oct 9.

Drugs

Indications