PMID- 36274674
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20221025
IS  - 1177-5467 (Print)
IS  - 1177-5483 (Electronic)
IS  - 1177-5467 (Linking)
VI  - 16
DP  - 2022
TI  - Triple Fixed-Combination Bimatoprost/Brimonidine/Timolol in Glaucoma and Ocular 
      Hypertension in India: A Multicenter, Open-Label, Phase 3 Study.
PG  - 3559-3569
LID - 10.2147/OPTH.S369626 [doi]
AB  - INTRODUCTION: To evaluate the intraocular pressure (IOP)-lowering efficacy and 
      safety of a triple fixed-combination of bimatoprost, brimonidine, and timolol 
      (TFC) in patients with glaucoma or ocular hypertension (OHT) treated with 
      fixed-combination or unfixed brimonidine and timolol therapy (dual-combination 
      therapy). METHODS: In this multicenter, open-label, phase 3 study, patients who 
      received 4-8 weeks of dual-combination therapy twice daily and had an IOP >18 and 
      <34 mmHg in at least one eye were switched (at baseline) to treatment with TFC 
      twice daily for 12 weeks. At Weeks 4, 8, and 12 on TFC, IOP was assessed at Hours 
      0, 2, and 8. Primary efficacy variable: mean diurnal IOP change from baseline in 
      the study eye at Week 12 (modified intent-to-treat [mITT] population). 
      Sensitivity (per-protocol [PP] population) and subgroup (</=65 vs >65 years) 
      analyses were performed. Safety, including adverse events (AEs), was assessed at 
      each visit. RESULTS: Of 126 patients enrolled, 121 and 103 formed the mITT/safety 
      and PP populations, including 109 (90.1%) and 94 (91.3%) who completed the study, 
      respectively. In the mITT/safety population, mean age was 58.6 years. Patients 
      had open-angle glaucoma (51.2%), angle-closure glaucoma with patent iridotomy 
      (36.4%), and/or OHT (13.2%). At Week 12, the mean diurnal change in IOP from dual 
      combination-treated baseline was statistically significant (P<0.001) with TFC in 
      the mITT (-3.98 mmHg) and PP (-4.22 mmHg) populations. Results were similar at 
      all visits, regardless of the age subgroup. The most frequent treatment-related 
      AEs were conjunctival hyperemia (14.0%) and dry eye (4.1%); 5.8% of the patients 
      discontinued treatment due to ocular AEs. CONCLUSION: TFC offers a beneficial 
      therapeutic alternative for patients with glaucoma or OHT whose IOP is not 
      sufficiently controlled with dual-combination therapy. Safety and efficacy 
      findings support those of published studies of TFC in primary open-angle glaucoma 
      and OHT, despite differences in study designs.
CI  - (c) 2022 Menon and Goodkin.
FAU - Menon, Meena G
AU  - Menon MG
AD  - Glaucoma Services, Sankara Eye Hospital, Bangalore, Karnataka, India.
FAU - Goodkin, Margot L
AU  - Goodkin ML
AUID- ORCID: 0000-0001-6392-3257
AD  - Ophthalmology Clinical Development, Allergan (an AbbVie Company), Irvine, CA, 
      USA.
LA  - eng
PT  - Journal Article
DEP - 20221020
PL  - New Zealand
TA  - Clin Ophthalmol
JT  - Clinical ophthalmology (Auckland, N.Z.)
JID - 101321512
PMC - PMC9582300
OTO - NOTNLM
OT  - alpha-agonist
OT  - beta-blocker
OT  - combination therapy
OT  - glaucoma
OT  - intraocular pressure
OT  - prostaglandin analog
COIS- MLG is an employee of AbbVie Inc and may hold AbbVie stock/share options. The 
      authors report no other conflicts of interest in this work.
EDAT- 2022/10/25 06:00
MHDA- 2022/10/25 06:01
PMCR- 2022/10/20
CRDT- 2022/10/24 03:45
PHST- 2022/04/06 00:00 [received]
PHST- 2022/08/22 00:00 [accepted]
PHST- 2022/10/24 03:45 [entrez]
PHST- 2022/10/25 06:00 [pubmed]
PHST- 2022/10/25 06:01 [medline]
PHST- 2022/10/20 00:00 [pmc-release]
AID - 369626 [pii]
AID - 10.2147/OPTH.S369626 [doi]
PST - epublish
SO  - Clin Ophthalmol. 2022 Oct 20;16:3559-3569. doi: 10.2147/OPTH.S369626. eCollection 
      2022.