Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2026
Levofloxacin/ketorolac combination versus levofloxacin alone for topically treating moderate-severe acute bacterial conjunctivitis: a randomized controlled trial.
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Bandello Francesco, Ledbedev Oleg Ivanovich, Alessio Giovanni, Avitabile Teresio, Castellino Niccolò, Covello Giuseppe, Figus Michele, Lisitsyn Aleksey, Lo Giudice Gregorio, Malygin Alexander, Nagomova Zoya, Nicolini Nicolò, Pioppo Antonino, Puzo Pasquale, Romano Dario, Rossetti Luca, Yavorky Andrey Evgenievich, Ciprandi Giorgio, Seleznev Aleksei, Malyugin Boris
Аннотация
BACKGROUND: This study aimed to obtain the first evidence-based microbiological confirmation of the efficacy and an assessment of the local tolerability of a combination of an ocular antibiotic and a non-steroidal anti-inflammatory drug in treating moderate-to-severe acute bacterial conjunctivitis (ABC).
METHODS: This was a phase II, randomized, parallel-group, masked-assessor, multicentre study to assess the non-inferiority of levofloxacin plus ketorolac eye drops versus levofloxacin eye drops alone in microbiological eradication (protocol number: LEVOKETO_02-2020). Treatment lasted 5 days. Non-inferiority was demonstrated if the lower bound of the two-sided 95% confidence interval (CI) of the difference was > -0.15. The study randomized 252 patients enrolled in 20 centers (Italy and Russia). The primary endpoint was the proportion of patients with microbiological eradication of levofloxacin-susceptible bacteria. Secondary endpoints included microbiological and clinical outcomes. This study is registered with EudraCT number 2020-005263-31.
RESULTS: At the final visit, 100% of patients in the test arm had eradicated levofloxacin-susceptible pathogens, versus 92.59% in the control arm (difference = 0.0741; 95% CI: 0.0042-0.1439). In the Per Protocol population, the levofloxacin-ketorolac eye drops combination proved to be superior (P < 0.0001) to levofloxacin eye drops alone in bacterial eradication during treatment of ABC with moderate-to-severe signs in adults despite being administered with a simplified dosing regimen. Local tolerability was similar between arms (p = 0.7666).
CONCLUSIONS: The levofloxacin-ketorolac combination was effective in bacterial eradication and well-tolerated in adults with moderate-to-severe ABC. These results suggest a possible positive levofloxacin-ketorolac interaction warranting further investigation in a phase III study.
METHODS: This was a phase II, randomized, parallel-group, masked-assessor, multicentre study to assess the non-inferiority of levofloxacin plus ketorolac eye drops versus levofloxacin eye drops alone in microbiological eradication (protocol number: LEVOKETO_02-2020). Treatment lasted 5 days. Non-inferiority was demonstrated if the lower bound of the two-sided 95% confidence interval (CI) of the difference was > -0.15. The study randomized 252 patients enrolled in 20 centers (Italy and Russia). The primary endpoint was the proportion of patients with microbiological eradication of levofloxacin-susceptible bacteria. Secondary endpoints included microbiological and clinical outcomes. This study is registered with EudraCT number 2020-005263-31.
RESULTS: At the final visit, 100% of patients in the test arm had eradicated levofloxacin-susceptible pathogens, versus 92.59% in the control arm (difference = 0.0741; 95% CI: 0.0042-0.1439). In the Per Protocol population, the levofloxacin-ketorolac eye drops combination proved to be superior (P < 0.0001) to levofloxacin eye drops alone in bacterial eradication during treatment of ABC with moderate-to-severe signs in adults despite being administered with a simplified dosing regimen. Local tolerability was similar between arms (p = 0.7666).
CONCLUSIONS: The levofloxacin-ketorolac combination was effective in bacterial eradication and well-tolerated in adults with moderate-to-severe ABC. These results suggest a possible positive levofloxacin-ketorolac interaction warranting further investigation in a phase III study.