SAFETY AND EFFICACY OF OFLOXACIN (0.3%), PREDNISOLONE (ACETATE 0.2%), AND TETRAHYDROZOLINE HYDROCHLORIDE (0.4%) COMBINATION EYE DROPS IN PATIENTS WITH BACTERIAL CONJUNCTIVITIS A PHASE IV, OPEN-LABEL STUDY

Abstract

Background: Adding anti-inflammatory and decongestant agents to antibiotics may mitigate the inflammation and symptoms of bacterial conjunctivitis until bacterial eradication occurs. We performed this study to investigate the safety and efficacy of ofloxacin, prednisolone, and tetrahydrozoline hydrochloride combination (Loxtra^TM eye drops) in bacterial conjunctivitis.

Materials and Methods: Fifty patients with clinically confirmed bacterial conjunctivitis were enrolled in this study. For seven days, each patient self-administered Loxtra^TM eye drops (ofloxacin 3 mg, prednisolone 2 mg, and tetrahydrozoline 0.4 mg). Clinical safety and efficacy outcomes were assessed at the end of the follow-up period.

Result: At the end of study (EOS) visit, 100%, 98%, and 100% of patients who used Loxtra^TM eye drops achieved ≥ one grade reduction in conjunctival discharge, ocular itching, and conjunctival redness scores. Compared to baseline values, we recorded significant reductions (p < 0.05) in the mean conjunctival discharge, ocular itching, and conjunctival redness scores by the first follow-up and EOS visits (after 3 and 7 days, respectively). The overall therapeutic response at the EOS visit was “Much Improved” for 100% of subjects. Regarding safety, only one patient experienced a severe headache. The adverse event was non-serious and related to the study drug. Otherwise, no adverse events were recorded.

Conclusion: Loxtra^TM eye drops demonstrated high safety and efficacy in treating patients with bacterial conjunctivitis and ameliorating their symptoms. Therefore, we recommend this product for clinical use in patients with bacterial conjunctivitis.

Keywords: Conjunctivitis; Ofloxacin; Prednisolone; Tetrahydrozoline Hydrochloride