Abstract
Purpose :
To assess the safety and efficacy of the PRO-157 ophthalmic solution in three different dosing regimens, versus Moxifloxacin, versus Gatifloxacin in patients with bacterial conjunctivitis.
Methods :
A phase II, double-blind, masked, controlled, multicenter, clinical trial of 300 subjects, randomized to either a three dosing regimens of pazufloxacin 0.09% ophthalmic solution (BID, n = 90; TID, n = 76; QID, n = 68) or moxifloxacin 0.3% (n = 82) or gatifloxacin 0.5% (n = 72). Follow-up was set on days 0, 3, and 7. Assessments of anterior / posterior segment ocular signs were performed. The primary outcome measures included conjunctival culture and clinical signs. Safety variables included adverse events, lisamine green and fluorescein ocular surface stains and clinical signs of tolerability.
Results :
The primary efficacy endpoints were similar between groups at baseline. After intervention time bacterial eradication were reported in all groups: pazufloxacin BID 79 %; pazufloxacin TID 84 %; pazufloxacin QID 84 %; Moxifloxacin 80 %; and Gatifloxacin 82 %. Similar results were reported in clinical resolution. However, there were not significantce differences between treatments. sto compare groups. The adverse events were not related to the interventions.
Conclusions :
Pazufloxacin in different dose regimens, showed similar bacteriological and clinical efficacy when compared to moxifloxacin and gatifloxacin in patients with bacterial conjunctivitis
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.