PMID- 38506750
OWN - NLM
STAT- Publisher
LR  - 20240320
IS  - 1536-481X (Electronic)
IS  - 1057-0829 (Linking)
DP  - 2024 Mar 4
TI  - Preservative-free Bimatoprost 0.01% Ophthalmic Gel for Glaucoma Therapy. A Phase 
      III Randomized Controlled Trial.
LID - 10.1097/IJG.0000000000002371 [doi]
AB  - PURPOSE: To evaluate the intraocular pressure (IOP)-lowering efficacy and safety 
      of a preservative-free bimatoprost 0.01% ophthalmic gel (PFB 0.01% gel) compared 
      with preserved bimatoprost 0.01% (PB 0.01%). DESIGN: Phase III, international, 
      multicenter, randomized, 2-parallel group, investigator-masked, 3-month treatment 
      duration. METHODS: Patients with glaucoma or ocular hypertension were randomized 
      after a 7 week run-in/washout period to receive once-daily PFB 0.01% gel (n=236) 
      or PB 0.01% (n=249) for 3 months. The primary efficacy measure was change from 
      baseline in IOP at Week 12. Safety measures included adverse events (AEs) and 
      assessment of conjunctival hyperemia. RESULTS: Mean change from baseline in IOP 
      at Week 12 in the PFB 0.01% gel and PB 0.01% were -9.72+/-2.97 mmHg and -9.47+/-3.06, 
      respectively at 8 am, -9.41+/-3.03 and -9.19+/-3.12 mmHg at 10 am, and -8.99+/-3.36 and 
      -8.54+/-3.44 mmHg at 4 pm. Noninferiority of PFB 0.01% gel to PB 0.01% was 
      demonstrated at Week 12 based on predetermined criteria (upper 95% confidence 
      interval margin of 1.5 mmHg at all timepoints). The most frequently reported AE 
      was conjunctival hyperemia; 13 (5.5%) patients with PFB 0.01% gel and 17 (6.8%) 
      patients with PB 0.01%. The percentage of patients experiencing a worsening from 
      baseline in conjunctival hyperemia score was lower with PFB 0.01% gel compared to 
      PB 0.01% at Week 6 (20.1% vs 29.3%, respectively) and Week 12 (18.3% vs 30.4%, 
      respectively). CONCLUSIONS: PFB 0.01% ophthalmic gel has the same efficacy in 
      lowering IOP as PB 0.01% and demonstrated less aggravation of conjunctival 
      hyperemia at Week 6 and Week 12.
CI  - Copyright (c) 2024 The Author(s). Published by Wolters Kluwer Health, Inc.
FAU - Munoz-Negrete, Francisco J
AU  - Munoz-Negrete FJ
AD  - Department of Ophthalmology, Hospital Universitario Ramon y Cajal, Madrid, Spain. 
      Facultad de Medicina, Universidad de Alcala, IRYCIS, Madrid, Spain.
AD  - Department of Ophthalmology, Aristotle University of Thessaloniki, School of 
      Medicine, AHEPA Hospital, Thessaloniki, Greece.
FAU - Topouzis, Fotis
AU  - Topouzis F
AD  - IRCCS-Fondazione Bietti, 00198 Rome, Italy.
FAU - Oddone, Francesco
AU  - Oddone F
AD  - Laboratoires Thea, 63000 Clermont-Ferrand, France.
FAU - Nissle, Sylvie
AU  - Nissle S
AD  - Eye Clinic of Medical Academy of Lithuanian University of Health Sciences, 
      Kaunas, Lithuania.
FAU - Rokicki, Dariusz
AU  - Rokicki D
AD  - Eye Clinic of Medical Academy of Lithuanian University of Health Sciences, 
      Kaunas, Lithuania.
FAU - Januleviciene, Ingrida
AU  - Januleviciene I
AD  - University of Montreal, Montreal, Canada.
FAU - Harasymowycz, Paul
AU  - Harasymowycz P
AD  - Bellevue Ophthalmology Clinics and Montreal Glaucoma Institute, Montreal, Canada.
AD  - Department of ophthalmology, University Hospitals UZ Leuven, Leuven, Belgium.
FAU - Stalmans, Ingeborg
AU  - Stalmans I
AD  - Research Group of Ophthalmology, Catholic University KU Leuven, Leuven, Belgium.
LA  - eng
PT  - Journal Article
DEP - 20240304
PL  - United States
TA  - J Glaucoma
JT  - Journal of glaucoma
JID - 9300903
SB  - IM
EDAT- 2024/03/20 12:44
MHDA- 2024/03/20 12:44
CRDT- 2024/03/20 11:23
PHST- 2023/05/16 00:00 [received]
PHST- 2024/02/05 00:00 [accepted]
PHST- 2024/03/20 12:44 [medline]
PHST- 2024/03/20 12:44 [pubmed]
PHST- 2024/03/20 11:23 [entrez]
AID - 00061198-990000000-00345 [pii]
AID - 10.1097/IJG.0000000000002371 [doi]
PST - aheadofprint
SO  - J Glaucoma. 2024 Mar 4. doi: 10.1097/IJG.0000000000002371.