Keratoconjunctivitis Sicca Model Study (KCS)

Study Purpose

Evaluate the efficacy and safety of pharmaceuticals designed to treat Keratoconjunctivitis Sicca (KCS) or dry eye syndrome in rabbits

Type of Model

Induction of keratoconjunctivitis sicca

Time

26 days to establish model
Up to 2 weeks of testing

Test System

New Zealand White rabbits
Animals are prescreened for ocular abnormalities

Deliverables

  • Evaluation of tear production using Schirmer tear tests and fluorescein tear breakup tests
  • Observations of changes in ocular structures throughout the study using slit lamp biomicroscopy and ophthalmoscopy
  • Comparison of test article to currently approved therapeutics
  • Tissue harvest and histopathological analysis (optional)
  • Bioanalysis of analyte concentrations in target tissues (optional)

Model Description

  • KCS is induced using atropine and low humidity conditions in New Zealand White rabbits
  • Treated control groups are established by administering cyclosporine  ophthalmic emulsion in conjunction with atropine
  • Ophthalmic exams are performed at customized timepoints to confirm decrease in tear production
  • Following induction, subjects may be treated with a test article and currently marketed therapeutic agent as a positive control

Benefits

  • More accurate classification of the test article’s treatment due to treated and untreated control groups
  • Consistent scoring of the eyes using FDA-required techniques
  • Advanced imaging equipment and expertise in-house to perform all evaluations on-site