Evidence map›Paper›PMID 24667994›Full record

Trial reportThe British journal of ophthalmology2014

Bimatoprost 0.03%/timolol 0.5% preservative-free ophthalmic solution versus bimatoprost 0.03%/timolol 0.5% ophthalmic solution (Ganfort) for glaucoma or ocular hypertension: a 12-week randomised controlled trial.

Ivan Goldberg, Rafael Gil Pina, Aitor Lanzagorta-Aresti, Rhett M Schiffman, Charlie Liu, Marina Bejanian

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in The British journal of ophthalmology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01177098 (Safety and Efficacy of a New Formulation of Bimatoprost/Timolol Ophthalmic Solution Compared With Bimatoprost/Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension), which is not on this map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
4.0field-weighted citation impact, top 7% 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.

NCT01177098 phase3completednot on this map

Safety and Efficacy of a New Formulation of Bimatoprost/Timolol Ophthalmic Solution Compared With Bimatoprost/Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

TypeinterventionalSponsorAllerganRan2010 to 2012Enrolled561ConditionsGlaucoma, Ocular HypertensionArmsbimatoprost /timolol formulation A fixed combination ophthalmic solution, bimatoprost/timolol fixed combination ophthalmic solution
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 48 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Review
  7. From Eye Care to Hair Growth: Bimatoprost.Pharmaceuticals (Basel, Switzerland) · 2024
    Review
  8. Article
  9. Article
  10. Preservatives in glaucoma medication.The British journal of ophthalmology · 2018
    Review
  11. Review
  12. Review
  13. Article
  14. Review
  15. Article
  16. Article
  17. Article
  18. Review
  19. 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 2 institutions in 2 countries.

Ivan GoldbergDepartment of Ophthalmology, University of Sydney, Sydney Eye Hospital, Sydney, Australia.
Rafael Gil PinaClinica Oftalmologica Rafael Gil Pina, Huelva, Spain.
Aitor Lanzagorta-ArestiFundacion Oftalmologica Del Mediterraneo, Valencia, Spain.
Rhett M SchiffmanAllergan, Inc., Irvine, California, USA (at the time the study was conducted).
Charlie LiuAllergan, Inc., Irvine, California, USA (at the time the study was conducted).
Marina BejanianAllergan, Inc., Irvine, California, USA (at the time the study was conducted).
Allergan (United States) · USSydney Hospital · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo compare the efficacy and safety of single-dose bimatoprost 0.03%/timolol 0.5% preservative-free (PF) ophthalmic solution with bimatoprost 0.03%/timolol 0.5% ophthalmic solution in patients with open-angle glaucoma or ocular hypertension.

methodsIn this multicentre, randomised, parallel-group study, patients were randomised to bimatoprost/timolol PF or bimatoprost/timolol once daily in the morning for 12 weeks. Primary efficacy endpoints, reflecting differing regional regulatory requirements, included change from baseline in worse eye intraocular pressure (IOP) in the per-protocol population at week 12, and the average eye IOP at weeks 2, 6 and 12 in the intent-to-treat population.

results561 patients were randomised (278 to bimatoprost/timolol PF; 283 to bimatoprost/timolol); 96.3% completed the study. Both treatment groups showed statistically and clinically significant mean decreases from baseline in worse eye IOP and in average eye IOP at all follow-up time points (p<0.001). Bimatoprost/timolol PF met all pre-established criteria for non-inferiority and equivalence to bimatoprost/timolol. Ocular adverse events were similar between treatment groups, with conjunctival hyperaemia being the most frequent. Most were mild or moderate in severity.

conclusionsBimatoprost/timolol PF demonstrated non-inferiority and equivalence in IOP lowering compared with bimatoprost/timolol, with no significant differences in safety and tolerability. TRIAL REGISTRATION NUMBER: NCT01177098.

Indexed as

AdultAgedAged, 80 and overAmidesAntihypertensive AgentsCloprostenolDouble-Blind MethodDrug CombinationsFemaleGlaucoma, Open-AngleHumansIntraocular PressureMaleMiddle AgedOcular HypertensionOphthalmic SolutionsAmidesAntihypertensive AgentsCloprostenolDrug CombinationsGanfortOphthalmic SolutionsPreservatives, PharmaceuticalTimololClinical TrialDrugsGlaucomaTreatment Medical

Identifiers

PMID24667994
PMCPMC4078699
OpenAlexW2127860932

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.