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

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• 作者：Robert M. Feldman^a ; ^{robert.m.feldman@uth.tmc.edu" class="auth_mail" title="E-mail the corresponding author} ; Gregory Katz^b ; Matthew McMenemy^c ; Douglas A. Hubatsch^d ; Tony Realini^e
• 刊名：American Journal of Ophthalmology
• 出版年：2016
• 出版时间：May 2016
• 年：2016
• 卷：165
• 期：Complete
• 页码：188-197
• 全文大小：336 K

文摘

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 monotherapy. 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.