Maximum medical therapy: Brinzolamide/brimonidine and travoprost/timolol fixed-dose combinations in glaucoma and ocular hypertension

S. Fabián Lerner, Francesco Oddone, Da Wen Lu, Ana Sanseau, Merce Guarro, Antonia Ridolfi, Douglas Hubatsch

Research output: Contribution to journalArticle

Abstract

Introduction: Maximal medical therapy (MMT) is the use of ≥3 classes of topical antiglaucoma agents to achieve maximal intraocular pressure (IOP) reduction while minimizing adverse effects and compliance challenges. Purpose: To evaluate the additive IOP-lowering effect of twice-daily brinzolamide 1%/ brimonidine 0.2% fixed-dose combination (BBFC) used adjunctively with once daily travoprost 0.004%/timolol 0.5% fixed-dose combination (TTFC) in patients with open-angle glaucoma (OAG)/ocular hypertension (OHT). Methods: In this phase IV, double-masked study, patients on TTFC for ≥28 days, aged ≥18 years, with mean IOP ≥19 and ≤28 mmHg in at least 1 eye were randomized to receive BBFC+TTFC (n=67) or vehicle+TTFC (n=67) for 6 weeks. The primary endpoint was mean change in diurnal IOP from baseline (BL, averaged over 09:00 and 11:00) at Week 6. Results: The study was terminated prematurely due to recruitment challenges. BL mean IOP was similar in both groups (BBFC+TTFC: 21.6±1.78mmHg; vehicle+TTFC: 21.8±1.90mmHg).Mean change in diurnal IOP from BL at Week 6 was greater with BBFC+TTFC (−4.25 mmHg, 95% confidence interval [CI]: −4.7, −3.8) than with vehicle+TTFC (−2.11 mmHg, 95% CI: −2.6, −1.6, treatment difference, −2.15 mmHg (95% CI: −2.8, −1.5; P<0.001). Ocular adverse events (AEs) were reported in 11.9% of patients given BBFC+TTFC and 7.5% of patients given vehicle+TTFC. The AE with highest frequency was punctate keratitis (3%) in the BBFC+TTFC group; eye irritation (3%) in the vehicle+TTFC group. Conclusion: BBFC+TTFC as MMT demonstrated clinically relevant and statistically significant reductions in mean diurnal IOP in patients with OAG/OHT. AEs were consistent with known safety profiles of individual medications.

Original languageEnglish
Pages (from-to)2411-2419
Number of pages9
JournalClinical Ophthalmology
Volume13
DOIs
Publication statusPublished - Jan 1 2019

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Keywords

  • Brinzolamide/brimonidine fixed-dose combination
  • IOP
  • Maximal medical therapy
  • Ocular hypertension
  • Open-angle glaucoma
  • Travoprost/timolol fixed-dose combination

ASJC Scopus subject areas

  • Ophthalmology

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