June 2020
Volume 61, Issue 7
Free
ARVO Annual Meeting Abstract  |   June 2020
Comparative analysis of generic and brand NSAIDS toxicity in human corneal stromal fibroblasts
Author Affiliations & Notes
  • Mikayla Fraunfelder
    Departments of VMTH and Biomedical Sciences, College of Veterinary Medicine, University of Missouri, Columbia, Missouri, United States
  • Ratnakar Tripathi
    Harry S. Truman Memorial Veterans' Hospital, Columbia, Missouri, United States
    Departments of VMTH and Biomedical Sciences, College of Veterinary Medicine, University of Missouri, Columbia, Missouri, United States
  • Sabeeh Kamil
    Harry S. Truman Memorial Veterans' Hospital, Columbia, Missouri, United States
    Departments of VMTH and Biomedical Sciences, College of Veterinary Medicine, University of Missouri, Columbia, Missouri, United States
  • Sydney Green
    Departments of VMTH and Biomedical Sciences, College of Veterinary Medicine, University of Missouri, Columbia, Missouri, United States
  • Lynn M. Martin
    Harry S. Truman Memorial Veterans' Hospital, Columbia, Missouri, United States
    Departments of VMTH and Biomedical Sciences, College of Veterinary Medicine, University of Missouri, Columbia, Missouri, United States
  • Nishant Rajiv Sinha
    Harry S. Truman Memorial Veterans' Hospital, Columbia, Missouri, United States
    Departments of VMTH and Biomedical Sciences, College of Veterinary Medicine, University of Missouri, Columbia, Missouri, United States
  • Alexandria Hofmann
    Departments of VMTH and Biomedical Sciences, College of Veterinary Medicine, University of Missouri, Columbia, Missouri, United States
  • Praveen Balne
    Harry S. Truman Memorial Veterans' Hospital, Columbia, Missouri, United States
    Departments of VMTH and Biomedical Sciences, College of Veterinary Medicine, University of Missouri, Columbia, Missouri, United States
  • Prashant R. Sinha
    Harry S. Truman Memorial Veterans' Hospital, Columbia, Missouri, United States
    Departments of VMTH and Biomedical Sciences, College of Veterinary Medicine, University of Missouri, Columbia, Missouri, United States
  • Jason T. Rodier
    Harry S. Truman Memorial Veterans' Hospital, Columbia, Missouri, United States
    Mason Eye Institute, School of Medicine, University of Missouri, Columbia, Missouri, United States
  • Rajiv R. Mohan
    Harry S. Truman Memorial Veterans' Hospital, Columbia, Missouri, United States
    Mason Eye Institute, School of Medicine, University of Missouri, Columbia, Missouri, United States
  • Footnotes
    Commercial Relationships   Mikayla Fraunfelder, None; Ratnakar Tripathi, None; Sabeeh Kamil, None; Sydney Green, None; Lynn Martin, None; Nishant Sinha, None; Alexandria Hofmann, None; Praveen Balne, None; Prashant Sinha, None; Jason Rodier, None; Rajiv Mohan, None
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2020, Vol.61, 2919. doi:
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      Mikayla Fraunfelder, Ratnakar Tripathi, Sabeeh Kamil, Sydney Green, Lynn M. Martin, Nishant Rajiv Sinha, Alexandria Hofmann, Praveen Balne, Prashant R. Sinha, Jason T. Rodier, Rajiv R. Mohan; Comparative analysis of generic and brand NSAIDS toxicity in human corneal stromal fibroblasts. Invest. Ophthalmol. Vis. Sci. 2020;61(7):2919.

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

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Abstract

Purpose : Topical NSAIDS drops are regularly used for the management of postoperative ocular inflammation after laser-refractive and cataract surgeries. Clinical research has documented the appearance of corneal pathologies such as red-eye, punctate keratopathy, stromal infiltrates, persistent epithelial defects, conjunctival ulceration, and scleral and corneal melting in patients after the use of ophthalmic NSAIDS drops. Using an in vitro model, we compared the impact of application dosage and preservative formula between generic and brand (Voltaren) NSAIDS, diclofenac.

Methods : Primary human stromal fibroblasts (hCSF) were generated from donor human corneas purchased from an eye bank. Primary cultures were grown by placing sectioned donor corneas on 35mm culture dishes and incubated in a humidified 5% CO2 incubator at 37°C in MEM medium supplemented with 10% fetal bovine serum. hCSFs were expanded in 6-well culture plates by seeding cells at an initial density of 7.5x104 cells/well in the presence or absence of 0.1% generic or brand (Voltaren) diclofenac. Voltaren contains preservatives sorbic acid and edetate sodium and has polyoxyl-35 as an emollient, whereas generic diclofenac contains polyquad polyquaternium-1 and tocophersolan as preservatives and mannitol as emollients. At 50% confluence, cells were treated with generic or brand diclofenac at a dosage of 1, 2, or 4 drops twice or four times a day. Changes in cellular phenotype, proliferation, apoptosis, and matrix metalloproteinase (MMP) expression were analyzed with microscopy, Ki67 staining, TUNEL assay, and qRT-PCR, respectively.

Results : A dosage of 2 drops twice a day caused no significant change in cellular toxicity or phenotype in the hCSFs for up to 48 hours. Furthermore, at this dosage, no notable cell death was observed for 72 hours. A dosage of 2 drops four times a day did cause a noticeable change in hCSF morphology and a 40% increase in cell death as compared to vehicle treated controls in both generic and brand treated TUNEL+ cells. qRT-PCR found no significant difference between mRNA levels of MMP -1, -2, -8, and -9 in cells treated with generic vs brand diclofenac.

Conclusions : No significant differences between brand vs generic diclofenac treated cells were observed. It appears that preservatives and emollients present in generic and brand diclofenac have little or no role in corneal toxicity.

This is a 2020 ARVO Annual Meeting abstract.

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