Evidence map›Paper›PMID 38430227›Full record

Trial reportGraefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie2024

Long-term intraocular pressure-lowering efficacy and safety of ripasudil-brimonidine fixed-dose combination for glaucoma and ocular hypertension: a multicentre, open-label, phase 3 study.

Hidenobu Tanihara, Tetsuya Yamamoto, Makoto Aihara, Noriko Koizumi, Atsuki Fukushima, Koji Kawakita, Satoshi Kojima, Toka Nakamura, Hideki Suganami, K-232 Clinical Study Group

Open access · hybridAbstract readMulticenter StudyClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
3.8field-weighted citation impact, top 7% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Review
  6. Article
  7. The Application of Rho Kinase Inhibitors in the Management of Glaucoma.International journal of molecular sciences · 2024
    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

10 authors at 4 institutions in 1 country.

Hidenobu TaniharaDepartment of Ophthalmology, Biei Municipal Hospital, 3-8-35 Naka-machi, Biei Town, Kamikawa-gun, Hokkaido, 071-0207, Japan. tanihara@pearl.ocn.ne.jp.ORCID http://orcid.org/0000-0002-0356-7411
Tetsuya YamamotoProf. Kazuo Iwata Memorial Kaijin Glaucoma Center, Kaiya Eye Clinic, Shizuoka, Japan.ORCID http://orcid.org/0000-0001-6683-0144
Makoto AiharaDepartment of Ophthalmology, The University of Tokyo, Tokyo, Japan.ORCID http://orcid.org/0000-0001-6810-0583
Noriko KoizumiDepartment of Biomedical Engineering, Faculty of Life and Medical Sciences, Doshisha University, Kyoto, Japan.ORCID http://orcid.org/0000-0002-6940-1334
Atsuki FukushimaDepartment of Ophthalmology, Tsukazaki Hospital, Hyogo, Japan.ORCID http://orcid.org/0000-0002-6350-2599
Koji KawakitaPharmaceutical Clinical Development Management Department, Kowa Company, Ltd., Tokyo, Japan.
Satoshi KojimaPharmaceutical Clinical Development Management Department, Kowa Company, Ltd., Tokyo, Japan.
Toka NakamuraMedical Affairs Department, Kowa Company, Ltd., Tokyo, Japan.
Hideki SuganamiData Science Center, Kowa Company, Ltd., Tokyo, Japan.ORCID http://orcid.org/0000-0001-9130-0137
K-232 Clinical Study Group
Kowa (Japan) · JPDoshisha University · JPNaga Municipal Hospital · JPThe University of Tokyo · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate the long-term efficacy and safety of ripasudil-brimonidine fixed-dose combination (RBFC), a new intraocular pressure (IOP)-lowering medication for glaucoma and ocular hypertension (OHT).

methodsThis prospective, multicentre (23 sites in Japan), open-label study enrolled patients with primary open-angle glaucoma (POAG), OHT or exfoliative glaucoma and assigned them to one of four combination therapy cohorts, based on previous treatment(s) received: prostaglandin (PG) analogue (Cohort 1); PG analogue and beta-adrenoceptor blocker (β-blocker) (Cohort 2); PG analogue, β-blocker and carbonic anhydrase inhibitor (Cohort 3); or other/no treatment (Cohort 4). After a ≥ 4-week screening period, eligible patients received twice-daily RBFC for 52 weeks in addition to the treatments they were already receiving. Efficacy was assessed by change in IOP from baseline through week 52. Adverse events and adverse drug reactions (ADRs) were monitored throughout.

resultsIn total, 179 patients from Cohort 1 (n = 48), Cohort 2 (n = 44), Cohort 3 (n = 41) and Cohort 4 (n = 46) entered the RBFC treatment period. For all cohorts, mean IOP was significantly reduced at 11:00 (2 h after instillation of RBFC) through week 52 with the changes from baseline at week 52 of - 2.7 to - 4.1 mmHg across cohorts; all p < 0.001. Common ADRs were conjunctival hyperaemia (58%), allergic conjunctivitis (18%) and blepharitis (17%), most of which were mild in severity.

conclusionThese data demonstrated the long-term efficacy and safety of RBFC, both alone and in combination with other anti-glaucoma agents. RBFC may offer a new treatment option for the long-term management of glaucoma and OHT.

trial registrationJapan Registry of Clinical Trials Identifier: jRCT2080225063. DATE OF REGISTRATION: 17 February 2020.

Indexed as

Antihypertensive AgentsBrimonidine TartrateIntraocular PressureIsoquinolinesOcular HypertensionSulfonamidesAgedDose-Response Relationship, DrugDrug CombinationsFemaleFollow-Up StudiesGlaucoma, Open-AngleHumansMaleMiddle AgedOphthalmic SolutionsAntihypertensive AgentsBrimonidine TartrateDrug CombinationsIsoquinolinesK-115Ophthalmic SolutionsSulfonamidesGlaucomaIntraocular pressureLong-term treatmentOcular hypertensionRipasudil-brimonidine fixed-dose combination

Identifiers

PMID38430227
PMCPMC11271374
OpenAlexW4392346876

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.