Evidence map›Paper›PMID 25170245›Full record

ArticleClinical ophthalmology (Auckland, N.Z.)2014

Safety and efficacy of fixed-combination travoprost/timolol in patients with open-angle glaucoma or ocular hypertension not controlled with timolol monotherapy.

Marcelo Lopes da Silva Jordão, Marcelo Hatanaka, Abayomi Ogundele, Maria Rosa Bet de Moraes Silva, Roberto Murad Vessani

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Clinical ophthalmology (Auckland, N.Z.), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01336569 (Safety and Efficacy of Using the Travoprost/Timolol Fixed Combination), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 37% 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.

NCT01336569 phase4completednot on this map

Safety and Efficacy of Using the Travoprost/Timolol Fixed Combination (DuoTrav®) in Patients With Open-Angle Glaucoma or Uncontrolled Ocular Hypertension by Beta-blocker Monotherapy (Timolol 0.5%)

TypeinterventionalSponsorAlcon ResearchRan2011 to 2012Enrolled50ConditionsGlaucomaArmsTravoprost 0.004%/timolol maleate 0.5% fixed combination
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. 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

5 authors at 1 institution in 1 country.

Marcelo Lopes da Silva JordãoFaculty of Medicine of Ribeirão Preto, University of São Paulo, São Paulo, Brazil.
Marcelo HatanakaUniversity of São Paulo School of Medicine, São Paulo, Brazil.
Abayomi OgundeleGlobal Medical Affairs, Alcon Laboratories, Inc., Fort Worth, TX, USA.
Maria Rosa Bet de Moraes SilvaFaculty of Medicine of Botucatu, Universidade Estadual Paulista (UNESP), São Paulo, Brazil.
Roberto Murad VessaniGeneral Hospital of Itapecerica da Serra, Serviço Social da Construção Civil do Estado de São Paulo (SECONCI-SP) São Paulo, Brazil.
Universidade de São Paulo · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess the intraocular pressure (IOP)-lowering effect of travoprost 0.004%/timolol 0.5% fixed-dose combination (TRAV/TIM-FC) in patients not achieving the target IOP of ≤18 mmHg while on timolol 0.5% (TIM) monotherapy.

methodsA multicenter, prospective, open-label study (NCT01336569) was conducted in patients with open-angle glaucoma or ocular hypertension. Eligible patients were receiving TIM monotherapy with a screening/baseline IOP of 19-35 mmHg in ≥1 eye. TIM was discontinued on the baseline visit day (no washout period) and TRAV/TIM-FC was initiated and administered once daily at 8 pm for 4-6 weeks. The primary efficacy variable was mean change in IOP from TIM-treated baseline to study end, measured by Goldmann applanation tonometry. Results were analyzed by analysis of variance and paired samples t-test (5% significance).

resultsA total of 49 patients were enrolled (mean age, 63 [range, 42-82] years; 55.1% White; 73.5% women), and 45 were included in the intent-to-treat (ITT) population. Mean duration of treatment with TRAV/TIM-FC was 31 days. Mean ± standard deviation IOP reduction from baseline (TIM) to the follow-up visit (TRAV/TIM-FC) was -5.0±3.6 mmHg. IOP decreased significantly (P<0.0001) from baseline (22.1±2.6 mmHg) to study end (17.1±3.9 mmHg) in the ITT population, with a mean IOP reduction of 22.3%. Most patients (n=33/45; 73.3%) achieved IOP ≤18 mmHg. Two patients experienced a total of four adverse events (AEs), including a patient who reported one serious AE (enterorrhagia) that was considered unrelated to treatment, and a patient who reported one event each of drug-related redness, pruritus, and foreign body sensation. Most patients (n=47/49; 95.9%) reported no AEs.

conclusionsTRAV/TIM-FC lowered IOP in patients who were not at target IOP while receiving TIM monotherapy, with most patients achieving an IOP ≤18 mmHg with TRAV/TIM-FC. TRAV/TIM-FC was well tolerated in this population.

Indexed as

DuoTrav®intraocular pressureprimary open-angle glaucomatime since diagnosis

Identifiers

PMID25170245
PMCPMC4144930
OpenAlexW2029415993

What OpenQuestion holds

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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.