Evidence map›Paper›PMID 35932001›Full record

Trial reportBMC ophthalmology2022

Effectiveness and safety of tafluprost in primary open-angle glaucoma and ocular hypertension: a post-marketing phase IV study in China.

Xinghuai Sun, Qinghuai Liu, Xin Tang, Ke Yao, Yan Li, Jin Yang, Mingchang Zhang, Huiping Yuan, Yan Zheng, Weining Li and 1 more

Open access · goldAbstract readClinical Trial, Phase IVMulticenter Study
In one paragraph

Trial report in BMC ophthalmology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.6field-weighted citation impact, top 36% 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

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Observational
  2. Article
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

11 authors at 11 institutions in 1 country.

Xinghuai SunDepartment of Ophthalmology and Visual Science, Eye and ENT Hospital, Shanghai Medical College, Fudan University, Shanghai, 200031, China. xhsun@shmu.edu.cn.
Qinghuai LiuDepartment of Ophthalmology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, Jiangsu Province, China.
Xin TangBeijing Ophthalmology and Visual Sciences Key Laboratory, Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Beijing, 100730, China.
Ke YaoEye Center, Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, 310009, Zhejiang Province, China.
Yan LiDepartment of Ophthalmology, First Affiliated Hospital of Kunming Medical University, Kunming, 650031, Yunnan Province, China.
Jin YangTianjin Eye Institute, Tianjin Key Lab of Ophthalmology and Visual Science, Tianjin Eye Hospital, Nankai University Affiliated Eye Hospital, Tianjin, 300020, China.
Mingchang ZhangDepartment of Ophthalmology, Tongji Medical College, Union Hospital, Huazhong University of Science & Technology, Wuhan, 430030, Hubei Province, China.
Huiping YuanDepartment of Ophthalmology, The Second Affiliated Hospital, Harbin Medical University, Harbin, 150001, Heilongjiang Province, China.
Yan ZhengDepartment of Ophthalmology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200092, China.
Weining LiDepartment of Ophthalmology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, 250012, Shandong Province, China.
Huacong PengDepartment of Cataract and Glaucoma, Wuhan Eyegood Ophthalmic Hospital, Wuhan, 430064, Hubei Province, China.
Beijing Tongren Hospital · CNEye & ENT Hospital of Fudan University · CNHe Eye Hospital · CNJiangsu Province Hospital · CNKunming Medical University · CNNankai University · CNQilu Hospital of Shandong University · CNSecond Affiliated Hospital of Harbin Medical University · CNSecond Affiliated Hospital of Zhejiang University · CNUnion Hospital · CNXinHua Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundProstaglandin analogs (PGAs) are the first-line treatment for primary open-angle glaucoma (POAG) and ocular hypertension (OH). This study aimed to confirm the effectiveness and safety of Tapros® (0.0015% tafluprost eye drops) in Chinese patients with POAG and OH.

methodsThis phase IV, multicenter, non-comparative, prospective study enrolled patients with POAG and OH in China between 12/27/2017 and 04/15/2020. Patients who were treatment-naïve or untreated within one month (group A) or with unreached intraocular pressure (IOP) target after previous monotherapy of other PGAs (group B) or non-PGA IOP-lowering drugs (group C) were treated with 0.0015% tafluprost for three months. The IOP reduction, response rate, and safety were observed.

resultsThere were 165, 89, and 31 patients in groups A, B, and C, with baseline IOPs of 22.4 ± 4.7, 21.0 ± 3.5, and 22.5 ± 3.2 mmHg, respectively. The least-square means and percentages of IOP reduction at 3 months for groups A, B, and C were 4.7 (19.8%), 1.6 (6.1%), and 4.6 mmHg (20.3%), respectively. A significant reduction in IOP was observed at each visit compared with baseline (all P < 0.05). At the final visit, 57.0% of the participants in group A achieved an IOP reduction of ≥ 20%, while 40.4% and 77.4% in groups B and C achieved an IOP reduction of ≥ 10%. Fifty-eight treatment-related adverse events occurred in 46 participants (15.7%), of which the most common one was conjunctival hyperemia (34/293, 11.6%).

conclusionsTafluprost showed a sustained and significant effect with tolerable adverse events in Chinese patients with POAG and OH who were treatment-naïve or untreated within one month or received prior treatments with unsatisfying outcomes.

Indexed as

GlaucomaGlaucoma, Open-AngleOcular HypertensionOcular HypotensionAntihypertensive AgentsHumansIntraocular PressureMarketingProspective StudiesProstaglandins FProstaglandins, SyntheticTreatment OutcomeAntihypertensive AgentsProstaglandins FProstaglandins, SynthetictafluprostChinaClinical trialOcular hypertensionPhase IVPrimary open-angle glaucomaTafluprost

Identifiers

PMID35932001
PMCPMC9356508
OpenAlexW4289944822

What OpenQuestion holds

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LicenceCC BY
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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.