A Randomized Trial of Fixed-Dose Combination Brinzolamide 1%/Brimonidine 0.2% as Adjunctive Therapy to Travoprost 0.004%

作者：Feldman Robert M^*; Katz Gregory; Mcmenemy Matthew; Hubatsch Douglas A; Realini Tony

来源：American Journal of Ophthalmology, 2016, 165: 188-197.

DOI：10.1016/j.ajo.2016.02.026

PURPOSE: To evaluate the safety and efficacy of adding fixed-combination brinzolamide 1%/brimonidine 0.2% (BBFC) as adjunctive therapy to travoprost 0.004% (TRAV) in patients with open-angle glaucoma or ocular hypertension.
DESIGN: Multicenter, randomized, double-masked, parallel-group phase 4 clinical trial.
METHODS: SETTING: Multicenter; 32 sites in the United States. PATIENT POPULATION: Total of 233 patients with open-angle glaucoma or ocular hypertension and with mean intraocular pressure (IOP) >= 21 mm Hg and < 32 mm Hg while receiving once-daily TRAV mono therapy. INTERVENTION: Masked BBFC or vehicle (3 times daily) adjunctive to TRAV for 6 weeks. MAIN OUTCOME MEASURE: Mean diurnal IOP averaged over 8 AM, 10 AM, 3 PM, and 5 PM time points at week 6. Superiority of BBFC + TRAV over vehicle + TRAV was based on statistical significance of a treatment difference favoring BBFC + TRAV.
RESULTS: Mean diurnal IOP at week 6 (least squares mean standard error) was 17.6 +/- 0.4 mm Hg and 20.7 +/- 0.4 mm Hg in the BBFC + TRAV and vehicle + TRAV groups, respectively (between-group difference, -3.2 +/- 0.5 mm Hg; P < .0001). Superiority of BBFC + TRAV over vehicle + TRAV was established. Mean and percent diurnal IOP change from baseline were significantly greater with BBFC + TRAV compared with vehicle + TRAV (P < .0001 for both). Conjunctival hyperemia was the most common treatment-related adverse event in either group (BBFC + TRAV, 12.8%; vehicle + TRAV, 6.0%).
CONCLUSIONS: Adjunctive treatment with BBFC added to TRAV resulted in lower mean diurnal IOP after 6 weeks of treatment compared with vehicle added to TRAV; this difference was both statistically and clinically significant.

• 出版日期2016-5