Adherence to Fixed-Combination Versus Unfixed Travoprost 0.004%/Timolol 0.5% for Glaucoma. or Ocular Hypertension: A Randomized Trial

PURPOSE: 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. DESIGN: Randomized, controlled, observer-masked clinical trial. METHODS: SETTING: Two US clinical sites. PATIENT POPULATION: 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. INTERVENTION: 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. MAIN OUTCOME MEASURE: 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 1013 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. (C) 2016 The Author(s). Published by Elsevier Inc.