A phase III, placebo controlled clinical trial of 0.5% levofloxacin ophthalmic solution for the treatment of bacterial conjunctivitis
- D G Hwang1,
- D J Schanzlin2,
- M H Rotberg3,
- G Foulks4,
- M B Raizman5,
- and the Levofloxacin Bacterial Conjunctivitis Placebo-Controlled Study Group*
- 1Department of Ophthalmology, University of California, San Francisco, San Francisco, CA, USA
- 2Shiley Eye Center, University of California, San Diego, San Diego, CA, USA
- 3Charlotte Eye Ear Nose and Throat Associates, Charlotte, NC, USA
- 4Department of Ophthalmology, University of Pittsburgh, Pittsburgh, PA, USA
- 5Department of Ophthalmology, Tufts University School of Medicine, Boston, MA, USA
- Correspondence to: David G Hwang, MD, Cornea and Refractive Surgery Service, Department of Ophthalmology, University of California, San Francisco School of Medicine, 10 Koret Way, San Francisco, CA 94143–0730, USA;
- Accepted 9 December 2002
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.
↵* Members of the Levofloxacin Placebo-controlled Bacterial Conjunctivitis Study Group are listed in the appendix.