Gatifloxacin 0.5% administered twice daily for the treatment of acute bacterial conjunctivitis in patients one year of age or older.

Abstract

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 μg/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.

• Authors: Warren Heller, Marilou Cruz, Yasmin Rusi Bhagat, Jesse M De Leon, Carlos Felix, Linda Villanueva, David A Hollander, Harold Jensen
• Journal: Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics (J Ocul Pharmacol Ther) Vol. 30 Issue 10 Pg. 815-22 (Dec 2014) ISSN: 1557-7732 [Electronic] United States
• PMID: 25244402 (Publication Type: Clinical Trial, Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Bacterial Agents
• Fluoroquinolones
• Gatifloxacin

Topics

• Acute Disease
• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Anti-Bacterial Agents (administration & dosage, adverse effects)
• Child
• Child, Preschool
• Conjunctivitis, Bacterial (drug therapy)
• Double-Blind Method
• Drug Administration Schedule
• Female
• Fluoroquinolones (administration & dosage, adverse effects)
• Gatifloxacin
• Humans
• Infant
• Male
• Middle Aged
• Treatment Outcome
• Young Adult