An in vitro method which assesses corneal epithelial toxicity due to antineoplastic, preservative and antimicrobial agents

Lens Eye Toxic Res. 1989;6(1-2):59-85.

Abstract

We developed an in vitro model for studying the cytotoxicity of pharmacologic agents on corneal epithelium employing 3H-thymidine incorporation. Primary rabbit corneal epithelial cell cultures were established, and the cells plated prior to each experiment. 3H-thymidine incorporation was measured after the addition of drug or vehicle to these confluent cells, and dose-response curves were generated. Marked inhibition of 3H-thymidine incorporation was reached at chemotherapeutic concentrations achieved clinically for cytosine arabinoside (10(-7) M), methotrexate (10(-3) M), and 5-fluorouracil (10(-6) M). A 10(-4) M concentration of 2-deoxycytidine, a naturally occurring competitive inhibitor of cytosine arabinoside, protected cells up to a concentration of 10(-5) M. We utilized these data to undertake an in vivo prophylaxis study in 13 leukemia patients receiving high-dose iv cytosine arabinoside. Topical deoxycytidine 10(-4) M and 1% prednisolone phosphate, given 12 hours prior to the start of antileukemic therapy, were effective in reducing symptoms and signs of keratitis; both were better than historical placebo-treated eyes. Ophthalmic preservatives were studied in vitro at concentrations used clinically: benzalkonium chloride (BAC) (0.004-0.02%) was the most toxic, thimerosal (TMS) (0.001-0.004%) intermediate, and chlorobutanol (CHB) (0.2-0.5%) the least toxic. Antiviral agents (final concentration) included: trifluridine (TFT) (1.0%), ethyldeoxuridine (EDU) (2.0%), and idoxuridine (IDU) (0.1%). Dose but not time-dependent concentrations of these 3 agents were noted to cause toxicity; however, (E)-5(2-bromovinyl)-2'-deoxyuridine (BVDU) (0.1%) was non-toxic. Similarly, tobramycin and amikacin were significantly less toxic than gentamicin and neomycin in this system. These in vitro cytotoxicity data correlate well with previous in vivo and pre-clinical corneal epithelial toxicity studies. Our model may be useful in the toxicologic study of future topical ophthalmic agents.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Aged
  • Aminoglycosides / toxicity*
  • Animals
  • Antineoplastic Agents / toxicity*
  • Antiviral Agents / toxicity*
  • Cells, Cultured
  • Cornea / drug effects*
  • Cytarabine / adverse effects
  • Cytarabine / therapeutic use
  • Deoxycytidine / therapeutic use
  • Double-Blind Method
  • Epithelium / drug effects
  • Female
  • Hodgkin Disease / complications
  • Hodgkin Disease / drug therapy
  • Humans
  • Keratitis / chemically induced
  • Keratitis / prevention & control
  • Leukemia / complications
  • Leukemia / drug therapy
  • Male
  • Middle Aged
  • Preservatives, Pharmaceutical / toxicity*
  • Rabbits
  • Thymidine / metabolism
  • Toxicology / methods*

Substances

  • Aminoglycosides
  • Antineoplastic Agents
  • Antiviral Agents
  • Preservatives, Pharmaceutical
  • Cytarabine
  • Deoxycytidine
  • Thymidine