A phase III clinical trial of 0.5% levofloxacin ophthalmic solution versus 0.3% ofloxacin ophthalmic solution for the treatment of bacterial conjunctivitis.
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.


METHODS
Prospective, randomized, active-controlled, double-masked, multicenter study.


METHODS
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.


METHODS
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.
Schwab
Ivan R
IR
Department of Ophthalmology, University of California-Davis, 4860 Y Street, Suite 2400, Sacramento, CA 95817, USA.
Friedlaender
Mitchell
M
McCulley
James
J
Lichtenstein
Steven J
SJ
Moran
C Thomas
CT
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001419:Bacteria / Q000302:isolation & purification; D002648:Child; D002675:Child, Preschool; D003228:Conjunctiva / Q000382:microbiology; D003234:Conjunctivitis, Bacterial / Q000188:drug therapy* / Q000382:microbiology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007223:Infant; D064704:Levofloxacin; D008297:Male; D008875:Middle Aged; D015242:Ofloxacin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D009883:Ophthalmic Solutions; D011446:Prospective Studies; D012449:Safety; D016896:Treatment Outcome
D000890:Anti-Infective Agents; D009883:Ophthalmic Solutions; D064704:Levofloxacin; D015242:Ofloxacin