June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Safety and efficacy of 0.09% Pazufloxacin ophthalmic solution vs gatixifloxacin 0.5% and moxifloxacin 0.5% in subjects with bacterial conjunctivitis: a multicenter randomized controlled trial
Author Affiliations & Notes
  • Aldo Arturo Oregon-Miranda
    Clinical research, Laboratorios Sophia S.A. de C.V., Zapopan Lso-841221-6d2, Mexico
  • Oscar Olvera
    Clinical research, Laboratorios Sophia S.A. de C.V., Zapopan Lso-841221-6d2, Mexico
  • Arieh R Mercado
    Clinical research, Laboratorios Sophia S.A. de C.V., Zapopan Lso-841221-6d2, Mexico
  • Leopoldo Baiza
    Clinical research, Laboratorios Sophia S.A. de C.V., Zapopan Lso-841221-6d2, Mexico
  • Footnotes
    Commercial Relationships   Aldo Oregon-Miranda, Laboratorios Sophia (F), Laboratorios Sophia (E); Oscar Olvera , Laboratorios Sophia (E), Laboratorios Sophia (F); Arieh Mercado, Laboratorios Sophia (F), Laboratorios Sophia (E); Leopoldo Baiza, Laboratorios Sophia (F), Laboratorios Sophia (I)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 1088. doi:
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      Aldo Arturo Oregon-Miranda, Oscar Olvera, Arieh R Mercado, Leopoldo Baiza; Safety and efficacy of 0.09% Pazufloxacin ophthalmic solution vs gatixifloxacin 0.5% and moxifloxacin 0.5% in subjects with bacterial conjunctivitis: a multicenter randomized controlled trial
      . Invest. Ophthalmol. Vis. Sci. 2017;58(8):1088.

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      © ARVO (1962-2015); The Authors (2016-present)

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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.

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