June 2022
Volume 63, Issue 7
Open Access
ARVO Annual Meeting Abstract  |   June 2022
In vitro safety evaluation of two eye drops solutions containing a combination of corticosteroid and antibiotic.
Author Affiliations & Notes
  • Santa Viola
    Research, Preclinical Development and Patents, SIFI SpA, Lavinaio, Sicilia, Italy
  • Giuseppe De Pasquale
    Research, Preclinical Development and Patents, SIFI SpA, Lavinaio, Sicilia, Italy
  • Maria Cristina Curatolo
    Research, Preclinical Development and Patents, SIFI SpA, Lavinaio, Sicilia, Italy
  • MARIA GRAZIA MAZZONE
    Research, Preclinical Development and Patents, SIFI SpA, Lavinaio, Sicilia, Italy
  • Cristina Zappulla
    Research, Preclinical Development and Patents, SIFI SpA, Lavinaio, Sicilia, Italy
  • Footnotes
    Commercial Relationships   Santa Viola SIFI S.p.A., Code E (Employment); Giuseppe De Pasquale SIFI S.p.A., Code E (Employment); Maria Cristina Curatolo SIFI S.p.A., Code E (Employment); MARIA MAZZONE SIFI S.p.A., Code E (Employment); Cristina Zappulla SIFI S.p.A., Code E (Employment)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2022, Vol.63, 2114 – F0130. doi:
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      Santa Viola, Giuseppe De Pasquale, Maria Cristina Curatolo, MARIA GRAZIA MAZZONE, Cristina Zappulla; In vitro safety evaluation of two eye drops solutions containing a combination of corticosteroid and antibiotic.. Invest. Ophthalmol. Vis. Sci. 2022;63(7):2114 – F0130.

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

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Abstract

Purpose : The combination of corticosteroid and antibiotic is the most commonly post-operative therapy use to prevent ocular infections. When the epithelial integrity is compromised the composition of the formulation, in terms of active ingredients and excipients, is important for the biocompatibility. The purpose of this study was to evaluate the potential cytotoxic effect of two different marketed preservative-free eye drops solutions containing corticosteroid and antibiotic.

Methods : Human corneal epithelial cells (HCE) were repeatedly exposed (6 times) for 5 min (short time repeated exposure, S.T.R.E.) at 1.5h intervals to Netildex (0.3% netilmicin + 0.1% dexamethasone) or Betabioptal (0.5% chloramphenicol + 0.2% betamethasone) at two different concentrations: undiluted and 1:20 of the marketed concentration. Benzalkonium 0.01% was used as CTRL+. This protocol was designed to simulate the posology and the residence time of eyedrops considering blinking and tearing. Cell viability was assessed in wash and no wash condition by MTT assay. Statistics were by One-way ANOVA.

Results : None of the products tested diluted (1:20) had any significant cytotoxic effect following S.T.R.E. protocol in both wash (Netildex 102.2%±4.3, Betabioptal 103.6%±3.2, respectively, as cell viability) and no wash conditions (Netildex 99.0% ±1.6, Betabioptal 101.2%±4.4, respectively, as cell viability). Interestingly, when tested undiluted, Betabioptal produced significant cytotoxic effects in both wash (24.2%±0.6 of cell viability) and no wash conditions (25.1%±0.3 of cell viability), with respect to Netildex which did not show any cytotoxic effect in both conditions (99.9%±3.5 and 107.8%±2.5, respectively), see figure A-B.

Conclusions : Netildex and Betabioptal, both preservative-free solutions, when used diluted according to Takahashi et. al, 2011, showed no cytotoxic concerns on corneal epithelium. On the contrary, when tested undiluted Betabioptal was found cytotoxic, while Netildex was found to be endowed with an advantageous cytocompatibility profile even at the concentration used in clinical ophthalmological practice.

This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.

 

Cell viability by S.T.R.E. protocol in HCE cells treated with Netildex or Betabioptal in wash (A) and no wash (B) conditions. ****p≤0.0001 vs Netildex. Cell viability cut-off was fixed at 50%. Statistical analysis was performed by One-way ANOVA plus Bonferroni post-hoc test.

Cell viability by S.T.R.E. protocol in HCE cells treated with Netildex or Betabioptal in wash (A) and no wash (B) conditions. ****p≤0.0001 vs Netildex. Cell viability cut-off was fixed at 50%. Statistical analysis was performed by One-way ANOVA plus Bonferroni post-hoc test.

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