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.
Levofloxacin/ketorolac combination versus levofloxacin alone for topically treating moderate-severe acute bacterial conjunctivitis: a randomized controlled trial
Covello, Giuseppe;Figus, Michele;
2026-01-01
Abstract
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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
