Evidence map›Paper›PMID 26453641›Full record

Trial reportThe British journal of ophthalmology2016

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.

Michael S Berlin, Cheryl Rowe-Rendleman, Ike Ahmed, Douglas T Ross, Akifumi Fujii, Takafumi Ouchi, Christine Quach, Andrew Wood, Caroline L Ward

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The British journal of ophthalmology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01670266 (A Double-masked, Placebo-controlled, Dose-escalation Study and Double-masked, Two-sequence, Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-9054 in Patients With Ocular Hypertension or Mild Open-Angle Glaucoma), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01670266 phase1completednot on this map

A Double-masked, Placebo-controlled, Dose-escalation Study and Double-masked, Two-sequence, Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-9054 in Patients With Ocular Hypertension or Mild Open-Angle Glaucoma

TypeinterventionalSponsorOno Pharma USA IncRan2012Enrolled60ConditionsOcular Hypertension (OHT), Mild Open Angle-glaucoma (OAG)ArmsONO-9054, Placebo
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Phase 2b, Randomized, 3-Month, Dose-Finding Study of Sepetaprost in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension: The ANGEL Study.Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics · 2022
    Trial
  4. Trial
  5. Article
  6. Review
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Michael S BerlinGlaucoma Institute of Beverly Hills & UCLA, Los Angeles, California, USA.
Cheryl Rowe-RendlemanOno Pharma-USA, Lawrenceville, New Jersey, USA.
Ike AhmedDepartment of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada.
Douglas T RossOno Pharma-USA, Lawrenceville, New Jersey, USA.
Akifumi FujiiOno Pharma-USA, Lawrenceville, New Jersey, USA.
Takafumi OuchiOno Pharma-USA, Lawrenceville, New Jersey, USA.
Christine QuachGlaucoma Institute of Beverly Hills & UCLA, Los Angeles, California, USA.
Andrew WoodOno Pharma-USA, Lawrenceville, New Jersey, USA.
Caroline L WardOno Pharma UK Ltd, London, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

aimsThe 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.

methodsThis 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.

resultsMild 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.

conclusionsPM 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.

Indexed as

AdolescentAdultAgedAged, 80 and overCross-Over StudiesDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleGlaucoma, Open-AngleHumansIntraocular PressureMaleMiddle AgedOcular HypertensionOphthalmic SolutionsOphthalmic SolutionsOxepinspropan-2-yl 4-(6-(4-(2,5-difluorophenoxy)-3-hydroxybut-1-en-1-yl)-7-hydroxyoctahydro-2H-cyclopenta(b)oxepin-3-yl)butanoateprostaglandin F2alpha receptorReceptors, ProstaglandinReceptors, Prostaglandin E, EP3 SubtypeGlaucomaIntraocular pressurePharmacology

Identifiers

PMID26453641
PMCPMC4893083

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.