Topical Lomefloxacin 0.3% Twice Daily versus Tobramycin 0.3% in Acute Bacterial Conjunctivitis: A Multicenter Double-Blind Phase III Study

Abstract

Aims/Background: To evaluate in a double-masked comparative, prospective, randomized multicenter trial the efficacy of lomefloxacin 0.3% eye drops twice daily and of tobramycin eye drops 4 times daily in patients with acute bacterial conjunctivitis. Methods: Ninety-nine subjects were enrolled: 50 were treated with lomefloxacin 0.3% eye drops twice daily and 49 with tobramycin 0.3% eye drops 4 times daily. In all patients, conjunctival swabbing and assessment of objective signs and of subjective symptoms were performed. Results: There was no statistical difference for any individual sign or symptom or for the sum score of either key or other signs and symptoms at any of the examination days. The sum score of both key and other signs and symptoms decreased in both groups at day 3–4 as compared to baseline values (p < 0.0001). The decrease in both these scores continued significantly from day 3–4 to day 7–8 (p < 0.05) and was similar in the two treatment groups (p > 0.4). The lowest resistance rate was seen in lome-floxacin (3.5%) and in neomycin (7.0%), while tobramycin showed resistance in 10 out of 88 resistance strains (11.4%). Conclusion: Both lomefloxacin 0.3% twice daily and tobramycin 0.3% administered 4 times daily were well tolerated and showed a high degree of clinical and microbiological efficacy in the treatment of acute bacterial conjunctivitis. Lomefloxacin caused less resistance than other antibiotics evaluated.

Meta-analysis of six clinical phase III studies comparing lomefloxacin 0.3% eye drops twice daily to five standard antibiotics in patients with acute bacterial conjunctivitis

“…A meta-analysis of six phase III clinical studies [1,10,12,20,24,26] with Okacin used at a dosage of one drop twice daily in comparison to a standard antibiotic treatment (chloramphenicol 0.5%, 5/day; gentamicin 0.3%, 3/day; fusidic acid 1%, 2/day; tobramycin 0.3%, 4/ day; norfloxacin 0.3%, 4/day) was carried out to evaluate the equivalence of efficacy, safety and local tolerance in patients suffering from acute bacterial conjunctivitis.…”

“…The six studies will be referred to by the country where they were run as UK [1], Finland [24], Switzerland [12], Italy [10], Spain [26], and France [20]. All were planned, conducted, monitored and evaluated according to the principles of good clinical practice.…”

“…In the two investigator-masked studies [1,24] eye drops were instilled only in the affected eye(s), while both eyes were treated in the other four studies [10,12,20,26]. Dosing from day 2 to day 7±9 was either one drop twice daily (morning and evening, bottle A) with Okacin or two, four or five times daily in the control groups, depending on which control antibiotic was used (Table 1).…”

“…Lomefloxacin 0.3% was found to be highly efficacious in bacterial conjunctivitis, bacterial keratitis or endophthalmitis in animal studies [14,23,28]. Clinical and microbiological efficacy was confirmed in various phase III clinical studies in patients suffering from bacterial conjunctivitis with a 3 times daily dosage regimen [17,35,36] and in six comparative studies using a loading dosage on day 1 and a follow-up regimen of one drop 2 times daily for 1 week [1,10,12,20,24,26]. Lomefloxacin was found to be similar in efficacy to each of the standard antibiotics used.…”

Limitations of Current Antibiotics for the Treatment of Bacterial Conjunctivitis

“…Conjunctival bacterial eradication/control rates were 77 to 84% for gentamicin and 88 to 91% for tobramycin at day 11 (p ϭ 0.011). 15 Clinical cure and bacteriologic eradication/cure rates with gentamicin 0.3% and tobramycin 0.3% ophthalmic solutions compared favorably with the older fluoroquinolones, including ciprofloxacin, 17,18 norfloxacin, 19 ofloxacin, 11,12 and lomefloxacin 20,21 in doublemasked, randomized, clinical trials. Clinical cure rates of 65 and 71% and bacteriologic cure rates of 76 and 72% were reported for gentamicin and norfloxacin, respectively, following a 7-or 10-day treatment course (day of culture not specified).…”