Ripasudil–Brimonidine Fixed-Dose Combination vs Ripasudil or Brimonidine: Two Phase 3 Randomized Clinical Trials - 21/03/23
, Tetsuya Yamamoto b, Makoto Aihara c, Koji Kawakita d, Satoshi Kojima d, Mizuho Kanazawa e, Toshiaki Nojima f, Hideki Suganami fK-232 Clinical Study Group1
Résumé |
PURPOSE |
To confirm the superiority of the intraocular pressure (IOP)-lowering effect of the ripasudil−brimonidine fixed-dose combination (RBFC, K-232) to ripasudil 0.4% or brimonidine 0.1% ophthalmic solution.
DESIGN |
Two prospective multicenter, randomized, double- or single-masked, active-controlled, phase 3 trials.
METHODS |
Patients with primary open-angle glaucoma or ocular hypertension whose IOP level was ≥18 mm Hg during treatment with ripasudil or brimonidine alone were randomized to 2 groups (RBFC and ripasudil) in a 1:1 ratio in the ripasudil-controlled trial and to 3 groups (RBFC, brimonidine, and ripasudil–brimonidine combination) in a 2:2:1 ratio in the brimonidine-controlled trial. The allocated study drugs were instilled twice daily for 8 weeks. The primary efficacy endpoint was the change in IOP 2 hours after instillation (11 AM) from the baseline to weeks 4, 6, and 8.
RESULTS |
There were 206 patients randomized in the ripasudil-controlled trial. Changes in IOP were −2.6 and −1.2 mm Hg in the RBFC and ripasudil groups, respectively, with a difference of −1.4 mm Hg (95% CI = −1.8 to −1.0 mm Hg; P < .001). There were 282 randomized patients in the brimonidine-controlled trial. Changes in IOP were −3.4 and −1.5 mm Hg in the RBFC and brimonidine groups, respectively, with a difference of −1.8 mm Hg (95% CI = −2.3 to −1.4 mm Hg; P < .001). The most frequent adverse event was conjunctival hyperemia.
CONCLUSIONS |
The IOP-lowering effect of RBFC was superior to that of ripasudil or brimonidine.
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| Supplemental Material available at AJO.com. Parts of the data in the manuscript were presented in abstract form at the 33rd meeting of the Japan Glaucoma Society, 2022. |
Vol 248
P. 35-44 - avril 2023 Retour au numéro
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