Key result
Once-daily ONO-9054 lowers intraocular pressure by ~7 mmHg, with evening dosing causing slightly more hyperaemia.
Why the study?
ONO-9054 is effective in lowering intraocular pressure in ocular hypertension and open-angle glaucoma, but the effects of morning versus evening dosing on tolerability and IOP lowering were not compared.
RCT (n=12)
Double-masked
Randomized crossover
No
Absolute Event Rate: -6.8% vs -7.5%
Supports flexible once-daily ONO-9054 dosing by patient preference or tolerability; extends RCT data on timed IOP-lowering efficacy.
BACKGROUND/AIMS: The novel prostaglandin E (EP) 3 and prostaglandin F (FP) receptor agonist ONO-9054 is effective in lowering intraocular pressure (IOP) in patients with ocular hypertension and open-angle glaucoma when administered once daily. This study compares the effects of morning (AM) versus evening (PM) dosing of ONO-9054 on tolerability and IOP lowering. METHODS: This was a single-centre, randomised, double-masked, two-sequence, placebo-controlled crossover study in 12 subjects with bilateral primary open-angle glaucoma or ocular hypertension. Two 14-day crossover regimens were separated by a 2-week washout: ONO-9054 (1 drop to each eye) in the morning (07:00) and vehicle in the evening (19:00) and vice versa. IOP was measured multiple times during select days. Ocular examinations also evaluated safety and tolerability. RESULTS: Mild ocular hyperaemia, reported by six subjects with PM dosing, was the most frequent adverse event. Mild to moderate dryness was also slightly more frequent after PM dosing. Maximum IOP reduction from baseline occurred on day 2 with decreases from baseline of -7.4 mm Hg (-30.8%) for AM dosing and -9.1 mm Hg, (-38.0%) for PM dosing; after 14 days, mean reduction in IOP was -6.8 mm Hg (-28.6%) for AM dosing and -7.5 mm Hg (-31.0%) for PM dosing. CONCLUSIONS: PM dosing of ONO-0954 was associated with a slightly increased frequency of mild hyperaemia and mild to moderate dryness. Both dosing schedules provided sustained reduction in IOP. TRIAL REGISTRATION NUMBER: NCT01670266.
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Berlin et al. (2015) conducted an RCT in Primary open-angle glaucoma or ocular hypertension (n=12). ONO-9054 morning dosing vs. ONO-9054 evening dosing was evaluated on Mean reduction in intraocular pressure (IOP) from baseline at 14 days. Both morning and evening once-daily dosing of ONO-9054 provided sustained reductions in intraocular pressure (mean reductions of 6.8 mm Hg and 7.5 mm Hg at 14 days, respectively), with evening dosing associated with slightly more mild hyperaemia.
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