Purpose: To compare the efficacy, tolerability, and persistence of a fixed triple combination (FTC) of bimatoprost 0.01%/brimonidine tartrate 0.15%/timolol maleate 0.5% with the same agents administered separately. Secondary outcomes included adverse effects, quality of life (QoL), and adherence. Methods: This randomized clinical trial included 46 patients with primary open-angle ( n = 36) or primary angle-closure glaucoma ( n = 10) requiring three or more hypotensive agents. After a washout period, participants were randomized to FTC twice daily or to bimatoprost 0.03% once, brimonidine 0.2%, and timolol 0.5% twice daily. Examinations at 1, 4, and 6 months included conjunctival hyperemia grading, tear break-up time, corneal staining, and validated questionnaires assessing QoL, ocular surface, and adherence. Results: Mean age was 65.0 ± 11.5 years; baseline mean deviation –11.94 ± 8.72 dB, and prior treatment 3.9 ± 2.5 years. Both regimens significantly reduced intraocular pressure (FTC group: 24.37 ± 5.92 to 15.42 ± 2.69 mmHg; unfixed group: 26.18 ± 6.79 to 14.53 ± 3.49 mmHg; P < 0.001), with no difference between groups. Hyperemia worsened ( P = 0.009), QoL declined ( P < 0.001), and adherence remained stable. Discontinuation reached 63%, mainly from disease progression (34.5%) and intolerance (27.6%). Survival analysis showed a 69.6% probability of treatment maintenance at 6 months. Among completers, 61.8% had worsening hyperemia ( P = 0.004), whereas discontinuers exhibited QoL decline ( P < 0.001). In FTC, the visual field deteriorated in the discontinued group (Δ–1.11; P = 0.025). Conclusions: Both regimens achieved similar efficacy but were associated with progressive hyperemia, reduced QoL, and low persistence, underscoring the limitations of multiple topical glaucoma therapy.
Machado et al. (Wed,) studied this question.