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

Abstract 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