Evidence map›Paper›PMID 26907933›Full record

Trial reportGraefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie2016

Comparison of preservative-free latanoprost and preservative-free bimatoprost in a multicenter, randomized, investigator-masked cross-over clinical trial, the SPORT trial.

Ingeborg Stalmans, Francesco Oddone, Maria Francesca Cordeiro, Anton Hommer, Giovanni Montesano, Luisa Ribeiro, Gordana Sunaric-Mégevand, Luca Rossetti

Abstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 22% 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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. From Eye Care to Hair Growth: Bimatoprost.Pharmaceuticals (Basel, Switzerland) · 2024
    Review
  6. Article
  7. Review
  8. Article
  9. 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

8 authors at 5 institutions in 4 countries.

Ingeborg StalmansDepartment of Ophthalmology, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium. ingeborg.stalmans@mac.com.
Francesco OddoneGlaucoma Research Unit, G.B.Bietti Eye Foundation - IRCCS, Via Livenza 3, 00198, Rome, Italy.
Maria Francesca CordeiroICORG - Imperial College Ophthalmologic Research Group, Western Eye Hospital, 171 Marylebone Road, London, NW1 5QH, UK.
Anton HommerHommer Ophthalmology Institute, Albertgasse 39, A-1080, Vienna, Austria.
Giovanni MontesanoCentre for Clinical Trials at San Paolo Hospital, University of Milan, via di Rudinì, 8, 20142, Milan, Italy.
Luisa RibeiroAIBILI - Association for Innovation and Biomedical Research on Light and Image, Centre for Clinical Trials, Azinhaga Santa Comba, Celas, 3000-548, Coimbra, Portugal.
Gordana Sunaric-MégevandClinical Research Center, Mèmorial A de Rotschild, 22 Chemin Beau Soleil, 1208, Geneva, Switzerland.
Luca RossettiCentre for Clinical Trials at San Paolo Hospital, University of Milan, via di Rudinì, 8, 20142, Milan, Italy.
University of Milan · ITAssociation for Innovation and Biomedical Research on Light and Image · PTFondazione G.B. Bietti · ITKU Leuven · BEWestern Eye Hospital · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe aim of this study was to investigate the efficacy and safety of Bimatoprost Unit Dose Preservative Free (BUDPF) and Latanoprost Unit Dose Preservative Free (LUDPF).

methodsA prospective, randomized, investigator-masked, cross-over comparison was used. Inclusion criteria were ocular hypertension (OHT) or open-angle glaucoma (OAG) with a maximum intraocular pressure (IOP) of 21 mmHg on a preserved prostaglandin monotherapy. After 6 weeks washout, patients were randomized to BUDPF or LUDPF for 3 months and then switched to the other treatment for 3 months. IOP curves were performed at baseline and after each treatment period. Statistical analysis was performed in a R programming environment. Linear mixed modeling was used to account for repeated measures on the same subject and clustering of observations from the same center. Safety outcomes included visual acuity, adverse events, slit-lamp biomicroscopy, ocular tolerability, and optic nerve assessment.

resultsAnalysis at 6 months (primary outcome) showed a 1.6 ± 0.5-mmHg difference in IOP values between LUDPF and BUDPF (p < 0.01). A mean intra-subject IOP difference of 0.9 ± 0.2 mmHg (LUDPF - BUDPF) was observed (p < 0.01).. Significant differences in IOP were observed for both drugs at 3 and at 6 months compared to baseline: -4,0 ± 0.5 mmHg for both BUDPF and LUDPF at 3 months (p < 0.01 for both drugs; p = 0.32 between the two drugs); -5.2 ± 0.5 and -3.4 ± 0.5 mmHg for BUDPF and LUDPF, respectively (both p < 0.01), at 6 months. Both drugs were tolerated well, the only statistically significant difference being lower hyperemia scores for LUDPF (albeit low for both drugs).

conclusionsThis study demonstrates a superior efficacy of BUDPF over LUDPF in lowering IOP. The results are consistent both in the parallel comparison between the two treatment groups at 6 months as well as in the intra-subject pressure comparison.

Indexed as

Antihypertensive AgentsBimatoprostCross-Over StudiesDouble-Blind MethodGlaucoma, Open-AngleHumansIntraocular PressureLatanoprostOcular HypertensionOphthalmic SolutionsPreservatives, PharmaceuticalProspective StudiesProstaglandins F, SyntheticSlit LampTonometry, OcularTreatment OutcomeAntihypertensive AgentsBimatoprostLatanoprostOphthalmic SolutionsPreservatives, PharmaceuticalProstaglandins F, SyntheticBimatoprostCross-overLatanoprostPreservative-freeProstaglandin

Identifiers

PMID26907933
OpenAlexW2282547049

What OpenQuestion holds

Textmetadata
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.