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Maximum Medical Therapy: Brinzolamide/Brimonidine And Travoprost/Timolol Fixed-Dose Combinations In Glaucoma And Ocular Hypertension.
Lerner, S Fabián; Oddone, Francesco; Lu, Da-Wen; Sanseau, Ana; Guarro, Merce; Ridolfi, Antonia; Hubatsch, Douglas.
Afiliação
  • Lerner SF; Consultorio Oftalmológico Dr. Fabian Lerner And Facultad de Ciencias Médicas, Universidad Favaloro, Buenos Aires, Argentina.
  • Oddone F; Glaucoma Research Unit, IRCCS - Fondazione Bietti, Rome, Italy.
  • Lu DW; Department of Ophthalmology, Tri-Service General Hospital, Taipei, Taiwan, Republic of China.
  • Sanseau A; Instituto de la Visión, Ciudad de Buenos Aires, Argentina.
  • Guarro M; Vallès Oftalmologia Recerca-OMIQ and Ophthalmology Department, Hospital de Granollers, Barcelona, Spain.
  • Ridolfi A; Novartis Pharma S.A.S, Paris, France.
  • Hubatsch D; Novartis Pharmaceutical Corporation, Fort Worth, TX, USA.
Clin Ophthalmol ; 13: 2411-2419, 2019.
Article em En | MEDLINE | ID: mdl-31824135
INTRODUCTION: Maximal medical therapy (MMT) is the use of ≥3 classes of topical anti-glaucoma 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±1.78 mmHg; vehicle+TTFC: 21.8±1.90 mmHg). 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.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials Idioma: En Revista: Clin Ophthalmol Ano de publicação: 2019 Tipo de documento: Article País de afiliação: Argentina País de publicação: Nova Zelândia
Texto completo
Adicionar na Minha BVS
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials Idioma: En Revista: Clin Ophthalmol Ano de publicação: 2019 Tipo de documento: Article País de afiliação: Argentina País de publicação: Nova Zelândia