PMID- 25244402
OWN - NLM
STAT- MEDLINE
DCOM- 20150806
LR  - 20181202
IS  - 1557-7732 (Electronic)
IS  - 1080-7683 (Linking)
VI  - 30
IP  - 10
DP  - 2014 Dec
TI  - Gatifloxacin 0.5% administered twice daily for the treatment of acute bacterial 
      conjunctivitis in patients one year of age or older.
PG  - 815-22
LID - 10.1089/jop.2014.0040 [doi]
AB  - PURPOSE: To evaluate the efficacy and safety of gatifloxacin 0.5% ophthalmic 
      solution administered twice daily for treatment of acute bacterial 
      conjunctivitis. METHODS: Two identically designed, double-masked, multicenter 
      studies in the United States and India enrolled patients 1 year or older with 
      acute bacterial conjunctivitis. Patients were randomized to gatifloxacin 0.5% or 
      vehicle treatment for 5 days. Clinical success in clearing conjunctival hyperemia 
      and discharge at day 6 (primary endpoint) and day 4 and microbiological cure were 
      determined. Isolates from positive conjunctival samples were tested for 
      sensitivity and susceptibility. Safety measures included adverse events (AEs). 
      Data from these 2 studies were pooled for these analyses. RESULTS: Of the 1437 
      randomized patients, 658 constituted the modified intent-to-treat population. 
      Patient characteristics were similar between the pooled treatment groups. 
      Clinical success occurred for 58.0% of gatifloxacin 0.5%-treated versus 45.5% 
      vehicle-treated patients at day 6 (P=0.001) and for 23.7% versus 15.4% in the 
      respective groups at day 4 (P=0.007). Microbiological cure was higher with 
      gatifloxacin 0.5% than vehicle at days 4 and 6 (P<0.001 for both time points). 
      The combined minimum inhibitory concentration required to inhibit 90% of isolates 
      for gatifloxacin 0.5% was 2.0 mug/mL for gram-positive and gram-negative 
      organisms. AEs were reported by 11.6% and 13.3% of patients in the gatifloxacin 
      0.5% and vehicle safety populations, respectively. One patient in each treatment 
      group experienced a serious AE; neither was treatment related. CONCLUSIONS: The 
      0.5% concentration of gatifloxacin ophthalmic solution was safe and effective for 
      treatment of acute bacterial conjunctivitis with twice-daily administration for 5 
      days.
FAU - Heller, Warren
AU  - Heller W
AD  - 1 Arizona Center for Clinical Trials , Phoenix, Arizona.
FAU - Cruz, Marilou
AU  - Cruz M
FAU - Bhagat, Yasmin Rusi
AU  - Bhagat YR
FAU - De Leon, Jesse M
AU  - De Leon JM
FAU - Felix, Carlos
AU  - Felix C
FAU - Villanueva, Linda
AU  - Villanueva L
FAU - Hollander, David A
AU  - Hollander DA
FAU - Jensen, Harold
AU  - Jensen H
LA  - eng
SI  - ClinicalTrials.gov/NCT00509873
PT  - Clinical Trial
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
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  - L4618BD7KJ (Gatifloxacin)
SB  - IM
MH  - Acute Disease
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anti-Bacterial Agents/*administration & dosage/adverse effects
MH  - Child
MH  - Child, Preschool
MH  - Conjunctivitis, Bacterial/*drug therapy
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Fluoroquinolones/*administration & dosage/adverse effects
MH  - Gatifloxacin
MH  - Humans
MH  - Infant
MH  - Male
MH  - Middle Aged
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2014/09/23 06:00
MHDA- 2015/08/08 06:00
CRDT- 2014/09/23 06:00
PHST- 2014/09/23 06:00 [entrez]
PHST- 2014/09/23 06:00 [pubmed]
PHST- 2015/08/08 06:00 [medline]
AID - 10.1089/jop.2014.0040 [doi]
PST - ppublish
SO  - J Ocul Pharmacol Ther. 2014 Dec;30(10):815-22. doi: 10.1089/jop.2014.0040.