June 2020
Volume 61, Issue 7
Open Access
ARVO Annual Meeting Abstract  |   June 2020
Efficacy and safety of a reduced posology of Netilmicin/Dexamethasone ophthalmic gel versus the eye drops in the treatment of inflammation conditions following cataract surgery
Author Affiliations & Notes
  • Claudine Annie Civiale
    Clinical Development, SIFI S.p.A, Lavinaio Aci Sant'Antonio, Italy
  • Rita Mencucci
    S.O.D.Oculistica, Azienda Ospedaliera Universitaria Careggi, Italy
  • Anja Liekfeld
    Klinik fur Augenheilkunde Klinikum Ernest von Bergman, Germany
  • Antonio Scialdone
    U.O. Oculistica 1, Ospedale Fatebenefratelli e Oftalmico ASST Fatebenefratelli Sacco, Italy
  • Thomas Ach
    Augenklinik und Poliklinik of Wurzburg, Germany
  • MARIA GRAZIA MAZZONE
    Clinical Development, SIFI S.p.A, Lavinaio Aci Sant'Antonio, Italy
  • Aldo Caporossi
    U.O.C. Oculistica, Policlinico Universitario "A. Gemelli", Italy
  • Footnotes
    Commercial Relationships   Claudine Annie Civiale, SIFI SpA (E); Rita Mencucci, None; Anja Liekfeld, None; Antonio Scialdone, None; Thomas Ach, None; MARIA MAZZONE, SIFI SpA (E); Aldo Caporossi, None
  • Footnotes
    Support  NONE
Investigative Ophthalmology & Visual Science June 2020, Vol.61, 1688. doi:
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      Claudine Annie Civiale, Rita Mencucci, Anja Liekfeld, Antonio Scialdone, Thomas Ach, MARIA GRAZIA MAZZONE, Aldo Caporossi; Efficacy and safety of a reduced posology of Netilmicin/Dexamethasone ophthalmic gel versus the eye drops in the treatment of inflammation conditions following cataract surgery. Invest. Ophthalmol. Vis. Sci. 2020;61(7):1688.

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

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Abstract

Purpose : To demonstrate the twice a day (BID) efficacy and safety of Netilmicin/Dexamethasone ophthalmic hydrogel containing Xanthan gum, versus Netilmicin/Dexamethasone eye drops four times a day (QID), in the treatment of inflammatory conditions after cataract surgery in the presence or at risk of microbial infection.

Methods : Phase III international multicenter (n=5) double-blind, non-inferiority study: a total of 168 patients, male and female, aged >40 years, were randomized to receive the Netilmicin/Dexamethasone ophthalmic hydrogel BID (N=85) or the eye drops QID (N=83) from the day of phaco-emulsification cataract extraction (Day0) until Day15. To ensure double masking, the gel group received 2 doses of active treatment and 2 doses of placebo. Patients were evaluated at Screening Visit (4 to 7 days before cataract surgery), Visit 2 (Day0), Visit 3 (Day1), Visit 4 (Day7±1), Visit 5 (Day15±2) and at Visit 6 (Follow-up Day60±3). Full responders (patients with absence of cells and flare in anterior chamber) percentage were evaluated at 7 days as primary endpoint. Difference of full responder proportion was analyzed by Chi square test for proportion along with one-sided 97.5% confidence interval of the difference based on Student’s t distribution. Secondary parameters (microbial measurements, intraocular pressure, evaluation of ocular discomfort, visual acuity and safety) were evaluated at each visit.

Results : Flare and cellularity were resolved at Day 7 post-surgery in 92.5% of patients and completely by Day 15. In both ITT (Intent to Treat) and PP (Per Protocol) populations, efficacy analysis showed that the hydrogel BID is non-inferior to the QID administered eye drops. For ITT analysis, the lower limit of the 97.5% confidence interval (-0.0580) is greater than the non-inferiority limit of -0.10. For the PP analysis the lower limit of the 97.5% confidence Interval (-0.0562) is greater than the non-inferiority limit of -0.10. For secondary parameters, no differences were observed between the two treatment groups. No microbial load and no safety issues were observed.

Conclusions : The current study demonstrated that hydrogel reduced posology (BID) is not inferior to the approved eye drops posology (QID) for the clinical response obtained after 7 days. Both treatments were very well tolerated and efficacious.

This is a 2020 ARVO Annual Meeting abstract.

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