Ripasudil-Brimonidine Fixed-Dose Combination vs Ripasudil or Brimonidine: Two Phase 3 Randomized Clinical Trials.
Am J Ophthalmol
; 248: 35-44, 2023 04.
Article
em En
| MEDLINE
| ID: mdl-36410471
ABSTRACT
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 11 ratio in the ripasudil-controlled trial and to 3 groups (RBFC, brimonidine, and ripasudil-brimonidine combination) in a 221 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.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Glaucoma de Ângulo Aberto
/
Hipertensão Ocular
Idioma:
En
Ano de publicação:
2023
Tipo de documento:
Article