A phase III, placebo controlled clinical trial of 0.5% levofloxacin ophthalmic solution for the treatment of bacterial conjunctivitis.

Abstract

AIM:

To compare the efficacy and safety of levofloxacin 0.5% ophthalmic solution (Quixin) with placebo for treatment of bacterial conjunctivitis.

METHODS:

In this prospective, randomised, placebo controlled, double masked, multicentre study, 249 patients with bacterial conjunctivitis received either 0.5% levofloxacin (n = 126) or placebo (n = 123) for 5 days, administered every 2 hours on days 1-2, then every 4 hours on days 3-5. Cultures were obtained and signs/symptoms evaluated at baseline, interim, and final visits. The end point was the last evaluable observation. Primary microbial outcomes were based on culture results; clinical outcomes were based on resolution of cardinal signs.

RESULTS:

117 patients (60 levofloxacin, 57 placebo) were evaluated. Microbial eradication rates were significantly greater with levofloxacin at all time points, reaching 90% at end point. In a subgroup analysis, differences in eradication rates at end point were most pronounced in children but were also statistically significant for levofloxacin in adults. Clinical cure rates were significantly greater with levofloxacin at final visit and end point. Statistically significant differences favouring levofloxacin were measured at end point for resolution of conjunctival discharge, bulbar conjunctival injection, palpebral conjunctival injection, burning/stinging, itching, and photophobia. Adverse events were similar between groups. Safety composite scores analysed by age indicated significantly fewer children on levofloxacin experienced worsening symptoms.

CONCLUSIONS:

Levofloxacin 0.5% ophthalmic solution is safe and effective for treatment of bacterial conjunctivitis.

• Authors: D G Hwang, D J Schanzlin, M H Rotberg, G Foulks, M B Raizman, Levofloxacin Bacterial Conjunctivitis Place-controlled Study Group
• Journal: The British journal of ophthalmology (Br J Ophthalmol) Vol. 87 Issue 8 Pg. 1004-9 (Aug 2003) ISSN: 0007-1161 [Print] England
• PMID: 12881345 (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-Infective Agents
• Ophthalmic Solutions
• Levofloxacin
• Ofloxacin

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Anti-Infective Agents (adverse effects, therapeutic use)
• Child
• Child, Preschool
• Conjunctivitis, Bacterial (drug therapy, microbiology)
• Double-Blind Method
• Female
• Humans
• Levofloxacin
• Male
• Middle Aged
• Ofloxacin (adverse effects, therapeutic use)
• Ophthalmic Solutions
• Prospective Studies
• Severity of Illness Index
• Treatment Outcome