title: Adherence to Fixed-Combination Versus Unfixed Travoprost 0.004%/Timolol 0.5% for Glaucoma or Ocular Hypertension: A Randomized Trial.
abstract: OBJECTIVE
  To assess adherence to treatment with fixed-combination travoprost 0.004%/timolol 0.5% (TTFC) compared with separate containers of travoprost 0.004% and timolol 0.5% (TRAV+TIM; unfixed) using electronic dosing aids.
  
  
  METHODS
  Randomized, controlled, observer-masked clinical trial.
  
  
  METHODS
  setting: Two US clinical sites.
  
  
  METHODS
  Eligible patients were adults diagnosed with open-angle glaucoma or ocular hypertension. Patients (n = 81) were sequentially randomized 1:1 to receive TTFC or TRAV+TIM for 12 months.
  
  
  METHODS
  TTFC was administered once daily in the morning or evening with a single dosing aid. Patients randomized to TRAV+TIM administered TRAV once daily in the evening and TIM once daily in the morning using separate dosing aids.
  
  
  METHODS
  Adherence with administered medication, as recorded by the dosing aids.
  
  
  RESULTS
  Mean ± SD patient age was 60 ± 10 years; most patients were male and white. Compared with TRAV+TIM (n = 40), patients receiving TTFC (n = 41) were consistently adherent on a greater percentage of days through month 12 (60% vs 43%). At months 1, 3, 6, and 12, 80% adherence was achieved by 71% vs 38%, 53% vs 30%, 45% vs 16%, and 32% vs 11% of patients receiving TTFC vs TRAV+TIM, respectively. Significantly more patients were adherent on ≥80% of days with TTFC compared with TRAV+TIM (P < .001 to P = .041). Both treatments reduced IOP from baseline, and no safety issues were identified in either group. Ocular hyperemia was the most common treatment-related adverse event (n = 3/group).
  
  
  CONCLUSIONS
  Patients receiving TTFC maintained better treatment adherence compared with patients receiving TRAV+TIM through 12 months of on-therapy evaluation. This suggests that, for patients requiring multiple IOP-lowering medications, a fixed combination may provide improved long-term adherence compared with unfixed therapy.
authors.affiliation: Specialty Eyecare Centre, Bellevue, Washington. Electronic address: hbarnebey@specialtyeyecarecentre.com.
authors.forename: Howard S
authors.initials: HS
authors.lastname: Barnebey
authors.affiliation: Department of Ophthalmology, Johns Hopkins University, Baltimore, Maryland; Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland; University of Maryland, Baltimore, Maryland; University of Michigan, Ann Arbor, Michigan.
authors.forename: Alan L
authors.initials: AL
authors.lastname: Robin
mesh_terms: D000319:Adrenergic beta-Antagonists / Q000008:administration & dosage; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000959:Antihypertensive Agents / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007322:Instillation, Drug; D007429:Intraocular Pressure / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D010349:Patient Compliance; D016037:Single-Blind Method; D013997:Time Factors; D013999:Timolol / Q000008:administration & dosage*; D014065:Tonometry, Ocular; D000069557:Travoprost / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D000319:Adrenergic beta-Antagonists; D000959:Antihypertensive Agents; D013999:Timolol; D000069557:Travoprost