Evidence map›Paper›PMID 27633513›Full record

Observational studyBMC ophthalmology2016

Tolerability and efficacy of bimatoprost 0.01 % in patients with open-angle glaucoma or ocular hypertension evaluated in the Taiwanese clinical setting: the Asia Pacific Patterns from Early Access of Lumigan 0.01 % (APPEAL Taiwan) study.

Ying Ying Chen, Tsing-Hong Wang, Catherine Liu, Kwou-Yeung Wu, Shin-Lin Chiu, Susan Simonyi, Da-Wen Lu

Registry-linked trialOpen access · goldAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in BMC 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 NCT01814761 (A Study of Bimatoprost 0.01% in the Clinical Setting), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.6field-weighted citation impact, top 28% 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.

NCT01814761 completednot on this map

A Study of Bimatoprost 0.01% in the Clinical Setting

TypeobservationalSponsorAllerganRan2013 to 2014Enrolled312ConditionsGlaucoma, Primary Open Angle, Ocular HypertensionArmsBimatoprost 0.01%
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 8 citations in OpenAlex.

  1. Review
  2. From Eye Care to Hair Growth: Bimatoprost.Pharmaceuticals (Basel, Switzerland) · 2024
    Review
  3. 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

7 authors at 6 institutions in 1 country.

Ying Ying ChenKaohsiung Veterans General Hospital, Kaohsiung City, Taiwan.
Tsing-Hong WangNational Taiwan University Hospital, Taipei City, Taiwan.
Catherine LiuTaipei Veterans General Hospital, Taipei City, Taiwan.
Kwou-Yeung WuKaohsiung Medical University Hospital, Kaohsiung City, Taiwan.
Shin-Lin ChiuChanghua Christian Hospital, Changhua City, Taiwan.
Susan SimonyiAllergan Singapore Pte Ltd., Singapore, Singapore.
Da-Wen LuTri-Service General Hospital, Taipei City, Taiwan. ludawen@yahoo.com.
Changhua Christian Hospital · TWKaohsiung Medical University Chung-Ho Memorial Hospital · TWKaohsiung Veterans General Hospital · TWNational Taiwan University Hospital · TWTaipei Veterans General Hospital · TWTri-Service General Hospital · TW

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn randomized, controlled trials of open-angle glaucoma (OAG) or ocular hypertension (OHT), bimatoprost 0.01 % improved tolerability while retaining the intraocular pressure (IOP)-lowering efficacy of bimatoprost 0.03 %. Given geographic/racial differences in glaucoma presentation, the APPEAL study assessed the occurrence and severity of hyperemia produced by bimatoprost 0.01 %, and its efficacy, in the Taiwanese clinical setting.

methodsIn this multicenter, open-label, observational study, treatment-naïve and previously treated patients with OHT or OAG received once-daily bimatoprost 0.01 % for 12 weeks. Hyperemia (primary endpoint) was graded at baseline, week 6, and week 12 using a photonumeric scale (0, +0.5, +1, +2, +3), grouped (≤ +1, none to mild; ≥ +2, moderate to severe), and reported as unchanged from baseline, improved, or worsened. IOP assessments followed the same schedule. Supplemental efficacy analyses were conducted based on previous therapies.

resultsThe intent-to-treat population (N = 312) included treatment-naïve (13.5 %) and previously treated (86.5 %) patients; mean age was 53.3 years. At baseline, 46.3 % of previously treated patients were receiving prostaglandin analog (PGA) monotherapy. At week 12, 91.2 %, 5.9 %, and 2.9 % of treatment-naïve patients exhibited unchanged, worsened, and improved hyperemia from baseline, respectively; 77.9 %, 12.9 %, and 9.2 % of previously treated patients showed no change, worsening, and improvement, respectively. There were no statistically significant shifts in hyperemia severity in either group, or in subgroups based on previous use of any PGA, any non-PGA, latanoprost, or travoprost monotherapies. In treatment-naïve patients, mean IOP reduction from baseline (18.0 ± 3.8 mm Hg) was 3.6 mm Hg at week 12 (P < 0.0001); 83.3 % had baseline IOP ≤ 21 mm Hg. In previously treated patients, mean additional IOP reduction from baseline (17.8 ± 3.9 mm Hg) was 2.6 mm Hg (P < 0.0001); similar results were observed in patient subgroups based on previous therapies.

conclusionsIn the Taiwanese clinical setting, bimatoprost 0.01 % provided significant IOP lowering in treatment-naïve patients (regardless of baseline IOP) and previously treated patients (even those with relatively low IOP on other therapies), while causing no significant changes in hyperemia from baseline.

trial registrationClinicaltrials.gov NCT01814761 . Registered 18 March 2013.

Indexed as

AdultAgedAntihypertensive AgentsBimatoprostFemaleGlaucoma, Open-AngleHumansHyperemiaIntention to Treat AnalysisIntraocular PressureMaleMiddle AgedOcular HypertensionAntihypertensive AgentsBimatoprostBimatoprostGlaucomaHyperemiaIntraocular pressureNormal-tension glaucomaOcular hypertensionProstaglandin analogProstamide

Identifiers

PMID27633513
PMCPMC5025541
OpenAlexW2519237435

What OpenQuestion holds

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LicenceCC BY
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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.