Evidence map›Paper›PMID 30944129›Full record

Trial reportBMJ open2019

Changes in ocular signs and symptoms in patients switching from bimatoprost-timolol to tafluprost-timolol eye drops: an open-label phase IV study.

Rupert Richard Alexander Bourne, Kai Kaarniranta, Katrin Lorenz, Carlo Enrico Traverso, Jouni Vuorinen, Auli Ropo

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IVMulticenter Study
In one paragraph

Trial report in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04609345 (Prevalence of Ocular Surface Disease in Malaysian Glaucoma Patients), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
4.8field-weighted citation impact, top 5% 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.

NCT04609345 unknown statusnot on this mapstarted 2020, after this paper: background citation

Prevalence of Ocular Surface Disease in Malaysian Glaucoma Patients

TypeobservationalSponsorSanten Pharma Malaysia Sdn BhdRan2020 to 2021Enrolled400ConditionsPrimary Open-angle Glaucoma, Primary Angle-Closure Glaucoma, Pseudoexfoliation Glaucoma, Pigment Dispersion Glaucoma
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 31 citations in OpenAlex.

  1. Trial
  2. Review
  3. From Eye Care to Hair Growth: Bimatoprost.Pharmaceuticals (Basel, Switzerland) · 2024
    Review
  4. Article
  5. Article
  6. Review
  7. Article
  8. Treatment of Open-Angle Glaucoma and Ocular Hypertension with Preservative-Free Tafluprost/Timolol Fixed-Dose Combination Therapy: Results from the VISIONARY Study Population in Spain.Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics · 2022
    Observational
  9. Article
  10. 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

6 authors at 5 institutions in 7 countries.

Rupert Richard Alexander BourneCambridge University Hospitals, Cambridge, UK.
Kai KaarnirantaDepartment of Ophthalmology, University of Eastern Finland and Kuopio University Hospital, Kuopio, Finland.
Katrin LorenzDepartment of Ophthalmology, University Medical Center, Johannes Gutenberg University Mainz, Mainz, Germany.
Carlo Enrico TraversoClinica Oculistica, Di.N.O.G.M.I., Università di Genova, and Ospedale Policlinico San Martino, Genova, Italy.
Jouni Vuorinen4Pharma Ltd, Turku, Finland.
Auli RopoGlobal Medical Affairs, Santen Oy, Helsinki, Finland.
Bridge University · SSOspedale Policlinico San Martino · ITSanten (Finland) · FIUniversity Medical Center of the Johannes Gutenberg University Mainz · DEUniversity of Eastern Finland · FI

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesBimatoprost-timolol (bimatoprost 0.03%-timolol 0.5% fixed-dose combination [FDC]) and tafluprost-timolol (tafluprost 0.0015%-timolol 0.5% FDC) eye drops are currently the only topical intraocular pressure (IOP)-reducing therapies available as preservative-free (PF) prostaglandin and timolol FDC. The aim of this study was to investigate changes to ocular signs and symptoms when patients with ocular hypertension (OH) or open-angle glaucoma (OAG) switched from PF or benzalkonium chloride (BAK)-preserved bimatoprost-timolol to PF tafluprost-timolol eye drops.

designThis was a 12-week, open-label, phase IV study.

settingSixteen centres in Finland, Germany, Italy and the UK.

participantsPatients with OH or OAG (IOP on medication ≤21 mm Hg), treated with PF or BAK-preserved bimatoprost-timolol for ≥4 weeks before screening, and presenting with conjunctival hyperaemia and ≥1 ocular symptom.

interventionsPatients were switched to PF tafluprost-timolol once daily in the treated eye(s). PRIMARY AND SECONDARY OUTCOME MEASURES: The primary endpoints were change from screening to week 12 in conjunctival hyperaemia and worst ocular symptom. The secondary outcome measures were changes from screening in ocular signs (other than conjunctival hyperaemia) and symptoms at week 12.

resultsOf 123 enrolled patients, 121 were included in the intention-to-treat dataset, of which all were Caucasian and 54.5% were female; 76 patients used BAK-preserved bimatoprost-timolol and 45 used PF drops. Conjunctival hyperaemia and severity of worst ocular symptom following switch to PF tafluprost-timolol significantly reduced from screening to week 12 in all patients (p<0.001). The percentage of patients with ocular signs and symptoms was significantly reduced at week 12 compared with screening (p<0.001). IOP was not affected by the change of treatment.

conclusionsSwitching from BAK-preserved or PF bimatoprost-timolol to tafluprost-timolol reduced both signs and symptoms of ocular surface disease with no clinically relevant effect on IOP. TRIAL REGISTRATION NUMBER: EudraCT2014-005273-37; Results.

Indexed as

AdultAgedAged, 80 and overAntihypertensive AgentsBimatoprostDrug Administration ScheduleDrug CombinationsFemaleGlaucoma, Open-AngleHumansIntention to Treat AnalysisIntraocular PressureMaleMiddle AgedOcular HypertensionOphthalmic SolutionsAntihypertensive AgentsBimatoprostDrug CombinationsOphthalmic SolutionsPreservatives, PharmaceuticalProstaglandins FtafluprostTimololclinical pharmacologyclinical trialsglaucomaintraocular pressuremedical ophthalmologyocular surface

Identifiers

PMID30944129
PMCPMC6500185
OpenAlexW2927044551

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.