PMID- 25170245
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20140829
LR  - 20211021
IS  - 1177-5467 (Print)
IS  - 1177-5483 (Electronic)
IS  - 1177-5467 (Linking)
VI  - 8
DP  - 2014
TI  - Safety and efficacy of fixed-combination travoprost/timolol in patients with 
      open-angle glaucoma or ocular hypertension not controlled with timolol 
      monotherapy.
PG  - 1527-34
LID - 10.2147/OPTH.S66613 [doi]
AB  - OBJECTIVE: To 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. 
      METHODS: A 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). RESULTS: A 
      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. CONCLUSIONS: TRAV/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.
FAU - Jordao, Marcelo Lopes da Silva
AU  - Jordao ML
AD  - Faculty of Medicine of Ribeirao Preto, University of Sao Paulo, Sao Paulo, 
      Brazil.
FAU - Hatanaka, Marcelo
AU  - Hatanaka M
AD  - University of Sao Paulo School of Medicine, Sao Paulo, Brazil.
FAU - Ogundele, Abayomi
AU  - Ogundele A
AD  - Global Medical Affairs, Alcon Laboratories, Inc., Fort Worth, TX, USA.
FAU - de Moraes Silva, Maria Rosa Bet
AU  - de Moraes Silva MR
AD  - Faculty of Medicine of Botucatu, Universidade Estadual Paulista (UNESP), Sao 
      Paulo, Brazil.
FAU - Vessani, Roberto Murad
AU  - Vessani RM
AD  - General Hospital of Itapecerica da Serra, Servico Social da Construcao Civil do 
      Estado de Sao Paulo (SECONCI-SP) Sao Paulo, Brazil.
LA  - eng
PT  - Journal Article
DEP - 20140818
PL  - New Zealand
TA  - Clin Ophthalmol
JT  - Clinical ophthalmology (Auckland, N.Z.)
JID - 101321512
PMC - PMC4144930
OTO - NOTNLM
OT  - DuoTrav(R)
OT  - intraocular pressure
OT  - primary open-angle glaucoma
OT  - time since diagnosis
EDAT- 2014/08/30 06:00
MHDA- 2014/08/30 06:01
PMCR- 2014/08/18
CRDT- 2014/08/30 06:00
PHST- 2014/08/30 06:00 [entrez]
PHST- 2014/08/30 06:00 [pubmed]
PHST- 2014/08/30 06:01 [medline]
PHST- 2014/08/18 00:00 [pmc-release]
AID - opth-8-1527 [pii]
AID - 10.2147/OPTH.S66613 [doi]
PST - epublish
SO  - Clin Ophthalmol. 2014 Aug 18;8:1527-34. doi: 10.2147/OPTH.S66613. eCollection 
      2014.