Efficacy and Safety of 0.6% Pazufloxacin Ophthalmic Solution Versus Moxifloxacin 0.5% and Gatifloxacin 0.5% in Subjects with Bacterial Conjunctivitis: A Randomized Clinical Trial.

Autor:	Baiza-Durán L; 1 Clinical Research Department , Laboratorios Sophia, SA de CV, Zapopan, México ., Olvera-Montaño O; 1 Clinical Research Department , Laboratorios Sophia, SA de CV, Zapopan, México ., Mercado-Sesma AR; 1 Clinical Research Department , Laboratorios Sophia, SA de CV, Zapopan, México .; 2 Department of Health-Disease Sciences, University Center of Tonala, University of Guadalajara , Guadalajara, Mexico ., Oregon-Miranda AA; 1 Clinical Research Department , Laboratorios Sophia, SA de CV, Zapopan, México ., Lizárraga-Corona A, Ochoa-Tabares JC, Pérez-Balbuena AL, Montoya-Sánchez IM, Saucedo-Rodríguez LR, Mora-González A, Gómez-Bastar PA, Villanueva-Najera MA, Sandoval-Delgadillo LI, González-Lomelí M, Páez-Garza JH, Orozco-Carroll M, Casillas-Magallanes M
Jazyk:	angličtina
Zdroj:	Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics [J Ocul Pharmacol Ther] 2018 Apr; Vol. 34 (3), pp. 250-255. Date of Electronic Publication: 2018 Jan 11.
DOI:	10.1089/jop.2017.0056
Abstrakt:	Purpose: The purpose of this study was to evaluate the clinical efficacy and safety of a novel ophthalmic solution of pazufloxacin on the ocular surface of patients with bacterial conjunctivitis after 7 days of intervention. Methods: This is a phase 2, double-blind, controlled, multicenter, clinical trial of 300 subjects, randomized to either a 3 dosing regimen of pazufloxacin 0.6% ophthalmic solution (twice a day [BID], n = 90; 3 times a day [TID], n = 76; 4 times a day [QID], n = 68), moxifloxacin 0.3% TID (n = 82), or gatifloxacin 0.5% TID (n = 72). Follow-up was set on days 0, 3, and 7. Assessments of ocular signs were performed, both anterior and posterior segments. The primary outcome measures included conjunctival culture and clinical signs. Safety variables included adverse events (AEs), lisamine green, fluorescein ocular surface stains, and clinical signs of tolerability. Results: After intervention, bacterial eradication was reported in all groups: pazufloxacin BID 79%, pazufloxacin TID 84%, pazufloxacin QID 84%, moxifloxacin 80%, and gatifloxacin 82%. There were no significant differences between treatments. Similar results were reported in clinical remission: pazufloxacin BID 89%, pazufloxacin TID 98%, pazufloxacin QID 92%, moxifloxacin 91%, and gatifloxacin 92% (P = 0.03 comparing pazufloxacin BID vs. TID). There were no differences between female and male responses. The AEs were not related to the interventions. Conclusions: A simplified dosing regimen was selected to follow the development of ophthalmic pazufloxacin based on its efficacy and safety profile. Pazufloxacin, 1 drop 3 times daily, showed similar rates of bacterial eradication and clinical remission compared with other fluoroquinolones.
Databáze:	MEDLINE
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