TY - JOUR
T1 - A phase III clinical trial of 0.5% levofloxacin ophthalmic solution versus 0.3% ofloxacin ophthalmic solution for the treatment of bacterial conjunctivitis
AU - Schwab, Ivan R.
AU - Friedlaender, Mitchell
AU - McCulley, James P
AU - Lichtenstein, Steven J.
AU - Moran, C. Thomas
AU - Abelson, Mark
AU - Bahadur, Gavin
AU - Braunstein, Richard
AU - Caine, Robert
AU - Cavanaugh, Timothy
AU - Dell, Steven
AU - Donshik, Peter
AU - Levy, Norman
AU - Milstein, Bernard
AU - Mundorf, Thomas
AU - O'Brien, Terrence
AU - Prepas, Steven
AU - Reidy, Robert
AU - Sall, Kenneth
AU - Sugar, Alan
AU - Valluri, Shailaja
AU - Wapner, Francis
AU - Wolf, Thomas
N1 - Funding Information:
Supported by Santen, Inc., Napa, California.
PY - 2003/3/1
Y1 - 2003/3/1
N2 - Objective: To compare the efficacy and safety of 0.5% levofloxacin ophthalmic solution (QUIXIN) with 0.3% ofloxacin ophthalmic solution for the treatment of bacterial conjunctivitis. Design: Prospective, randomized, active-controlled, double-masked, multicenter study. Participants: Four hundred twenty-three patients with a clinical diagnosis of bacterial conjunctivitis were enrolled. Methods: Patients were randomly assigned to receive either 0.5% levofloxacin (n = 211) or 0.3% ofloxacin (n = 212) for 5 days (every 2 hours on days 1 and 2 and every 4 hours on days 3-5). Conjunctival cultures were obtained, and ocular signs and symptoms were evaluated on day 1 (baseline), days 3 to 5 (interim), and days 6 to 10 (final). End point was defined as the last evaluable observation. Main Outcome Measures: Primary microbial and clinical outcomes were based on culture results and resolution of cardinal signs, respectively. Secondary efficacy assessments included evaluations of ocular signs and symptoms. Results: Two hundred eight patients (levofloxacin, n = 109; ofloxacin, n = 99) were evaluated for efficacy. Microbial eradication rates were significantly greater in the 0.5% levofloxacin treatment group compared with the 0.3% ofloxacin group at both the final visit (89% vs. 80%, P = 0.034) and at end point (90% vs. 81%; P = 0.038). Treatment with 0.5% levofloxacin was significantly more effective in resolving photophobia than was 0.3% ofloxacin treatment (94% vs. 73%, P = 0.006). Both study medications were well tolerated, with a low incidence of adverse events. Conclusions: Although clinical cure rates in the 0.5% levofloxacin and 0.3% ofloxacin treatment groups were similar, a 5-day treatment regimen with 0.5% levofloxacin achieved microbial eradication rates that were statistically superior to those attained with 0.3% ofloxacin. Despite the higher concentration of active drug in 0.5% levofloxacin versus 0.3% ofloxacin, there was no difference between treatment groups in the incidence of treatment-related adverse events.
AB - Objective: To compare the efficacy and safety of 0.5% levofloxacin ophthalmic solution (QUIXIN) with 0.3% ofloxacin ophthalmic solution for the treatment of bacterial conjunctivitis. Design: Prospective, randomized, active-controlled, double-masked, multicenter study. Participants: Four hundred twenty-three patients with a clinical diagnosis of bacterial conjunctivitis were enrolled. Methods: Patients were randomly assigned to receive either 0.5% levofloxacin (n = 211) or 0.3% ofloxacin (n = 212) for 5 days (every 2 hours on days 1 and 2 and every 4 hours on days 3-5). Conjunctival cultures were obtained, and ocular signs and symptoms were evaluated on day 1 (baseline), days 3 to 5 (interim), and days 6 to 10 (final). End point was defined as the last evaluable observation. Main Outcome Measures: Primary microbial and clinical outcomes were based on culture results and resolution of cardinal signs, respectively. Secondary efficacy assessments included evaluations of ocular signs and symptoms. Results: Two hundred eight patients (levofloxacin, n = 109; ofloxacin, n = 99) were evaluated for efficacy. Microbial eradication rates were significantly greater in the 0.5% levofloxacin treatment group compared with the 0.3% ofloxacin group at both the final visit (89% vs. 80%, P = 0.034) and at end point (90% vs. 81%; P = 0.038). Treatment with 0.5% levofloxacin was significantly more effective in resolving photophobia than was 0.3% ofloxacin treatment (94% vs. 73%, P = 0.006). Both study medications were well tolerated, with a low incidence of adverse events. Conclusions: Although clinical cure rates in the 0.5% levofloxacin and 0.3% ofloxacin treatment groups were similar, a 5-day treatment regimen with 0.5% levofloxacin achieved microbial eradication rates that were statistically superior to those attained with 0.3% ofloxacin. Despite the higher concentration of active drug in 0.5% levofloxacin versus 0.3% ofloxacin, there was no difference between treatment groups in the incidence of treatment-related adverse events.
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U2 - 10.1016/S0161-6420(02)01894-8
DO - 10.1016/S0161-6420(02)01894-8
M3 - Article
C2 - 12623805
AN - SCOPUS:0037373267
SN - 0161-6420
VL - 110
SP - 457
EP - 465
JO - Ophthalmology
JF - Ophthalmology
IS - 3
ER -