PMID- 31824135
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220411
IS  - 1177-5467 (Print)
IS  - 1177-5483 (Electronic)
IS  - 1177-5467 (Linking)
VI  - 13
DP  - 2019
TI  - Maximum Medical Therapy: Brinzolamide/Brimonidine And Travoprost/Timolol 
      Fixed-Dose Combinations In Glaucoma And Ocular Hypertension.
PG  - 2411-2419
LID - 10.2147/OPTH.S228777 [doi]
AB  - 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.
CI  - (c) 2019 Lerner et al.
FAU - Lerner, S Fabian
AU  - Lerner SF
AUID- ORCID: 0000-0002-4657-286X
AD  - Consultorio Oftalmologico Dr. Fabian Lerner And Facultad de Ciencias Medicas, 
      Universidad Favaloro, Buenos Aires, Argentina.
FAU - Oddone, Francesco
AU  - Oddone F
AD  - Glaucoma Research Unit, IRCCS - Fondazione Bietti, Rome, Italy.
FAU - Lu, Da-Wen
AU  - Lu DW
AD  - Department of Ophthalmology, Tri-Service General Hospital, Taipei, Taiwan, 
      Republic of China.
FAU - Sanseau, Ana
AU  - Sanseau A
AUID- ORCID: 0000-0001-8072-2916
AD  - Instituto de la Vision, Ciudad de Buenos Aires, Argentina.
FAU - Guarro, Merce
AU  - Guarro M
AD  - Valles Oftalmologia Recerca-OMIQ and Ophthalmology Department, Hospital de 
      Granollers, Barcelona, Spain.
FAU - Ridolfi, Antonia
AU  - Ridolfi A
AD  - Novartis Pharma S.A.S, Paris, France.
FAU - Hubatsch, Douglas
AU  - Hubatsch D
AD  - Novartis Pharmaceutical Corporation, Fort Worth, TX, USA.
LA  - eng
PT  - Journal Article
DEP - 20191205
PL  - New Zealand
TA  - Clin Ophthalmol
JT  - Clinical ophthalmology (Auckland, N.Z.)
JID - 101321512
PMC - PMC6901046
OTO - NOTNLM
OT  - IOP
OT  - brinzolamide/brimonidine fixed-dose combination
OT  - maximal medical therapy
OT  - ocular hypertension
OT  - open-angle glaucoma
OT  - travoprost/timolol fixed-dose combination
COIS- Fabian Lerner reports grants/research support/speaker fees from Allergan, 
      Glaukos, Iridex, Novartis/Alcon. Francesco Oddone reports personal fees from 
      Allergan, Centervue, Glaucoom and Omikron Italia, honoraria from Centervue, 
      Glaucoom Omikron Italia and Santen, and unrestricted grants from Allergan and 
      Omikron Italia. Ana Sanseau reports Honoraria and Consultation fees from 
      Novartis, Alcon, Poen, Baush & Lomb, Speaker's bureau: Novartis. Merce Guarro 
      reports grants/research support from Novartis, Alcon, and Santen. Antonia Ridolfi 
      and Doug Hubatsch are both employees of Novartis. The authors report no other 
      conflicts of interest in this work.
EDAT- 2019/12/12 06:00
MHDA- 2019/12/12 06:01
PMCR- 2019/12/05
CRDT- 2019/12/12 06:00
PHST- 2019/08/26 00:00 [received]
PHST- 2019/10/18 00:00 [accepted]
PHST- 2019/12/12 06:00 [entrez]
PHST- 2019/12/12 06:00 [pubmed]
PHST- 2019/12/12 06:01 [medline]
PHST- 2019/12/05 00:00 [pmc-release]
AID - 228777 [pii]
AID - 10.2147/OPTH.S228777 [doi]
PST - epublish
SO  - Clin Ophthalmol. 2019 Dec 5;13:2411-2419. doi: 10.2147/OPTH.S228777. eCollection 
      2019.