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

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...

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Bibliographic Details
Published in:British journal of ophthalmology 2003-08, Vol.87 (8), p.1004-1009
Main Authors: Hwang, D G, Schanzlin, D J, Rotberg, M H, Foulks, G, Raizman, M B
Format: Article
Language:English
Subjects:
Adolescent
Adult
Aged
Aged, 80 and over
Anti-Infective Agents - adverse effects
Anti-Infective Agents - therapeutic use
Antibiotics
Antimicrobial agents
bacterial conjunctivitis
Biological and medical sciences
Child
Child, Preschool
Clinical Science - Extended Reports
Conjunctivitis, Bacterial - drug therapy
Conjunctivitis, Bacterial - microbiology
Deoxyribonucleic acid
DNA
Double-Blind Method
Drug dosages
Eye
Family medical history
FDA approval
Female
fluoroquinolone
Humans
Laboratories
Levofloxacin
Male
Medical sciences
Middle Aged
Ofloxacin - adverse effects
Ofloxacin - therapeutic use
Ophthalmic Solutions
Pathogens
Pharmacology. Drug treatments
Prospective Studies
Quixin
Severity of Illness Index
Treatment Outcome
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Summary: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.
ISSN:0007-1161
1468-2079
DOI:10.1136/bjo.87.8.1004