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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<0.001 to P=0.041). 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.
Specialty Eyecare Centre, 1920 116th Avenue NE, Bellvue, WA 98004. Electronic address: hbarnebey@specialtyeyecarecentre.com.
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