PMID- 29624493
OWN - NLM
STAT- MEDLINE
DCOM- 20191001
LR  - 20191001
IS  - 1557-7732 (Electronic)
IS  - 1080-7683 (Linking)
VI  - 34
IP  - 3
DP  - 2018 Apr
TI  - Efficacy and Safety of 0.6% Pazufloxacin Ophthalmic Solution Versus Moxifloxacin 
      0.5% and Gatifloxacin 0.5% in Subjects with Bacterial Conjunctivitis: A 
      Randomized Clinical Trial.
PG  - 250-255
LID - 10.1089/jop.2017.0056 [doi]
AB  - PURPOSE: The purpose of this study was to evaluate the clinical efficacy and 
      safety of a novel ophthalmic solution of pazufloxacin on the ocular surface of 
      patients with bacterial conjunctivitis after 7 days of intervention. METHODS: 
      This is a phase 2, double-blind, controlled, multicenter, clinical trial of 300 
      subjects, randomized to either a 3 dosing regimen of pazufloxacin 0.6% ophthalmic 
      solution (twice a day [BID], n = 90; 3 times a day [TID], n = 76; 4 times a day 
      [QID], n = 68), moxifloxacin 0.3% TID (n = 82), or gatifloxacin 0.5% TID 
      (n = 72). Follow-up was set on days 0, 3, and 7. Assessments of ocular signs were 
      performed, both anterior and posterior segments. The primary outcome measures 
      included conjunctival culture and clinical signs. Safety variables included 
      adverse events (AEs), lisamine green, fluorescein ocular surface stains, and 
      clinical signs of tolerability. RESULTS: After intervention, bacterial 
      eradication was reported in all groups: pazufloxacin BID 79%, pazufloxacin TID 
      84%, pazufloxacin QID 84%, moxifloxacin 80%, and gatifloxacin 82%. There were no 
      significant differences between treatments. Similar results were reported in 
      clinical remission: pazufloxacin BID 89%, pazufloxacin TID 98%, pazufloxacin QID 
      92%, moxifloxacin 91%, and gatifloxacin 92% (P = 0.03 comparing pazufloxacin BID 
      vs. TID). There were no differences between female and male responses. The AEs 
      were not related to the interventions. CONCLUSIONS: A simplified dosing regimen 
      was selected to follow the development of ophthalmic pazufloxacin based on its 
      efficacy and safety profile. Pazufloxacin, 1 drop 3 times daily, showed similar 
      rates of bacterial eradication and clinical remission compared with other 
      fluoroquinolones.
FAU - Baiza-Duran, Leopoldo
AU  - Baiza-Duran L
AD  - 1 Clinical Research Department , Laboratorios Sophia, SA de CV, Zapopan, Mexico .
FAU - Olvera-Montano, Oscar
AU  - Olvera-Montano O
AD  - 1 Clinical Research Department , Laboratorios Sophia, SA de CV, Zapopan, Mexico .
FAU - Mercado-Sesma, Arieh R
AU  - Mercado-Sesma AR
AD  - 1 Clinical Research Department , Laboratorios Sophia, SA de CV, Zapopan, Mexico .
AD  - 2 Department of Health-Disease Sciences, University Center of Tonala, University 
      of Guadalajara , Guadalajara, Mexico .
FAU - Oregon-Miranda, Aldo A
AU  - Oregon-Miranda AA
AD  - 1 Clinical Research Department , Laboratorios Sophia, SA de CV, Zapopan, Mexico .
FAU - Lizarraga-Corona, Alfredo
AU  - Lizarraga-Corona A
FAU - Ochoa-Tabares, Juan C
AU  - Ochoa-Tabares JC
FAU - Perez-Balbuena, Ana L
AU  - Perez-Balbuena AL
FAU - Montoya-Sanchez, Irene M
AU  - Montoya-Sanchez IM
FAU - Saucedo-Rodriguez, Laura R
AU  - Saucedo-Rodriguez LR
FAU - Mora-Gonzalez, Alfredo
AU  - Mora-Gonzalez A
FAU - Gomez-Bastar, Pedro A
AU  - Gomez-Bastar PA
FAU - Villanueva-Najera, Miguel A
AU  - Villanueva-Najera MA
FAU - Sandoval-Delgadillo, Laura I
AU  - Sandoval-Delgadillo LI
FAU - Gonzalez-Lomeli, M
AU  - Gonzalez-Lomeli M
FAU - Paez-Garza, Juan H
AU  - Paez-Garza JH
FAU - Orozco-Carroll, Monica
AU  - Orozco-Carroll M
FAU - Casillas-Magallanes, Mauricio
AU  - Casillas-Magallanes M
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20180111
PL  - United States
TA  - J Ocul Pharmacol Ther
JT  - Journal of ocular pharmacology and therapeutics : the official journal of the 
      Association for Ocular Pharmacology and Therapeutics
JID - 9511091
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (Fluoroquinolones)
RN  - 0 (Ophthalmic Solutions)
RN  - 0 (Oxazines)
RN  - 4CZ1R38NDI (pazufloxacin)
RN  - L4618BD7KJ (Gatifloxacin)
RN  - U188XYD42P (Moxifloxacin)
SB  - IM
EIN - J Ocul Pharmacol Ther. 2019 Jan/Feb;35(1):76. PMID: 30699060
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anti-Bacterial Agents/administration & dosage/adverse effects/*pharmacology
MH  - Child
MH  - Child, Preschool
MH  - Conjunctivitis, Bacterial/diagnosis/*drug therapy
MH  - Double-Blind Method
MH  - Fluoroquinolones/administration & dosage/adverse effects/*pharmacology
MH  - Gatifloxacin/administration & dosage/adverse effects/*pharmacology
MH  - Haemophilus influenzae/drug effects
MH  - Humans
MH  - Infant
MH  - Infant, Newborn
MH  - Microbial Sensitivity Tests
MH  - Middle Aged
MH  - Moxifloxacin/administration & dosage/adverse effects/*pharmacology
MH  - Ophthalmic Solutions/administration & dosage/adverse effects/*pharmacology
MH  - Oxazines/administration & dosage/adverse effects/*pharmacology
MH  - Staphylococcus/drug effects
MH  - Young Adult
OTO - NOTNLM
OT  - conjunctivitis
OT  - ocular infection
OT  - ophthalmic antibiotics
OT  - pazufloxacin
EDAT- 2018/04/07 06:00
MHDA- 2019/10/02 06:00
CRDT- 2018/04/07 06:00
PHST- 2018/04/07 06:00 [entrez]
PHST- 2018/04/07 06:00 [pubmed]
PHST- 2019/10/02 06:00 [medline]
AID - 10.1089/jop.2017.0056 [doi]
PST - ppublish
SO  - J Ocul Pharmacol Ther. 2018 Apr;34(3):250-255. doi: 10.1089/jop.2017.0056. Epub 
      2018 Jan 11.