Evidence map›Paper›PMID 23743437›Full record

Trial reportThe British journal of ophthalmology2013

Bimatoprost 0.03% preservative-free ophthalmic solution versus bimatoprost 0.03% ophthalmic solution (Lumigan) for glaucoma or ocular hypertension: a 12-week, randomised, double-masked trial.

Douglas G Day, Thomas R Walters, Gail F Schwartz, Thomas K Mundorf, Charlie Liu, Rhett M Schiffman, Marina Bejanian

Registry-linked trialOpen access · hybridAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The British journal of ophthalmology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01099774 (Safety and Efficacy of Different Formulations of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension), which is not on this map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
5.2field-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.

NCT01099774 phase3completednot on this map

Safety and Efficacy of Different Formulations of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

TypeinterventionalSponsorAllerganRan2010 to 2011Enrolled597ConditionsGlaucoma, Ocular HypertensionArmsBimatoprost 0.03% Formulation B Ophthalmic Solution, Bimatoprost 0.03% Ophthalmic Solution
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 51 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Comparison of preservative-free latanoprost and preservative-free bimatoprost in a multicenter, randomized, investigator-masked cross-over clinical trial, the SPORT trial.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2016
    Trial
  4. Trial
  5. Review
  6. Article
  7. Review
  8. Review
  9. From Eye Care to Hair Growth: Bimatoprost.Pharmaceuticals (Basel, Switzerland) · 2024
    Review
  10. Article
  11. Review
  12. Preservatives in glaucoma medication.The British journal of ophthalmology · 2018
    Review
  13. Observational
  14. Review
  15. Article
  16. Article
  17. Article
  18. [Pharmacokinetics of the anterior eye].Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft · 2014
    Article
  19. One Year of Glaucoma Research in Review: 2012 to 2013.Asia-Pacific journal of ophthalmology (Philadelphia, Pa.)
    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 3 countries.

Douglas G DayCoastal Research Associates, Roswell, Georgia 30076, USA. dougday@bellsouth.net
Thomas R Walters
Gail F Schwartz
Thomas K Mundorf
Charlie Liu
Rhett M Schiffman
Marina Bejanian
Allergan (Ireland) · IEAllergan (United States) · USCharlotte Eye Ear Nose & Throat Associates · USHematology Oncology Associates · USJohns Hopkins University · USTexan Eye · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

aimTo evaluate efficacy and safety of bimatoprost 0.03% preservative-free (PF) ophthalmic solution versus bimatoprost 0.03% (Lumigan) ophthalmic solution for glaucoma or ocular hypertension.

methodsIn this double-masked, parallel-group study, patients were randomised to bimatoprost PF or bimatoprost for 12 weeks. The primary analysis for non-inferiority was change from baseline in worse eye intraocular pressure (IOP) in the per-protocol population at week 12. For equivalence, it was average eye IOP in the intent-to-treat population at each time point at weeks 2, 6 and 12.

results597 patients were randomised (bimatoprost PF, n=302 and bimatoprost, n=295). The 95% CI upper limit for worse eye IOP change from baseline was <1.5 mm Hg at each week 12 time point, meeting prespecified non-inferiority criteria. The 95% CI upper limit for the treatment difference for average IOP was 0.69 mm Hg and the lower limit was -0.50 mm Hg at all follow-up time points (hours 0, 2 and 8 at weeks 2, 6 and 12), meeting equivalence criteria. Both treatments showed decreases in mean average eye IOP at all follow-up time points (p<0.001), were safe and well tolerated.

conclusionsBimatoprost PF is non-inferior and equivalent to bimatoprost in its ability to reduce IOP-lowering with a safety profile similar to bimatoprost.

Indexed as

AdultAgedAged, 80 and overAmidesAntihypertensive AgentsBimatoprostCloprostenolDouble-Blind MethodFemaleGlaucomaHumansIntraocular PressureMaleMiddle AgedOcular HypertensionOphthalmic SolutionsAmidesAntihypertensive AgentsBimatoprostCloprostenolOphthalmic SolutionsPreservatives, PharmaceuticalGlaucomaIntraocular pressureOcular surfaceTreatment Medical

Identifiers

PMID23743437
PMCPMC3717762
OpenAlexW2124125931

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.