Evaluation of field effectiveness and safety of new medication for dogs for the treatment of immune-mediated keratoconjunctivitis sicca in client-owned dogs

The University of Florida College of Veterinary Medicine is currently recruiting dogs diagnosed with immune-mediated Keratoconjunctivitis sicca (“dry eye”) for a clinical research trial. The purpose of this study is to evaluate the use of an investigational new drug in the treatment of KCS in dogs.

Enrollment Status: Currently Enrolling

  • Inclusion Criteria:
    • Dogs must be ≥ 6 months old.
    • Diagnosis of KCS based on history and/or ophthalmic examination.
    • Schirmer Tear Test (STT) of ≥ 2 mm/minute and ≤ 10 mm/minute in one or both eyes.
    • Dogs must have a score of 2 or above on at least 2 of the 3 conjunctival signs associated with KCS.
    • Owner must be willing to comply with the protocol restrictions and the visit schedule.
    • Dogs with chronic medical conditions (for example, endocrinopathies, cardiovascular conditions, atopy, etc.) are permitted, but such conditions must be stabilized prior to enrolling the dog in the study and these animals must not be receiving prohibited concomitant medications.
  • Exclusion Criteria:
    • Dogs with non-KCS ophthalmic conditions that require one or more ophthalmic medications (e.g., glaucoma)
    • Dog diagnosed with KCS at < 6 months of age in order to exclude dogs that may have congenital alacrima.
    • Suspected neurogenic KCS.
    • History of removal of the third eyelid gland in the affected eye(s).
    • KCS associated with a diagnosis of canine distemper.
    • History of parotid duct transposition in the affected eye(s).
    • Punctal plugs in the affected eye(s).
    • Non-healed corneal ulcers.
    • History of local radiation therapy in the ocular region.
    • Other exclusion criteria not listed above will be discussed with you, include certain prohibited concomitant medications.
  • Treatment: Your dog will be screened to confirm that it fulfills the inclusion/exclusion criteria for this study. During screening, procedures include obtaining medical history, physical examination, blood and urine collection, obtaining a body weight, and an eye examination will be performed. This is a randomized, masked, negatively-controlled trial. Your dog will be randomly assigned to receive the investigational drug or a negative control product (sterile buffered saline). Neither you nor your veterinarian will be aware of whether your pet is assigned to receive the investigational drug or negative control product. Patients will be randomly assigned based on order of eligibility for enrollment to one of the two treatment groups in a 2:1 ratio of investigational drug to negative control product. If your dog is enrolled in the study, you, the owner/undersigned, will be asked to administer treatments to your dog pursuant to Sponsor’s instructions, which will be provided by your veterinarian.
  • Cost: Your dog will receive treatment under this study, including all tests, procedures, and medications, at no cost to you. If your dog has an allergic reaction or is injured as a result of participating in the study, the Sponsor will work with your veterinarian to cover reasonable expenses related to treatment of such reaction or injury. There are no additional expenses for participating in this study. If your pet is excluded or removed from the study, but requires continued care for eye disease, future examinations and procedures will NOT be covered by the research study. An estimate of costs for which you will be responsible will be prepared for you at the time of admission.
  • Contact: If you are interested in the study and would like to learn more, please complete the Study Interest Form to see if your dog qualifies.


Keratoconjunctivitis sicca (KCS), or dry-eye syndrome, results from deficiency in one or more components of tear production. This is a relatively common, spontaneous disease in dogs resulting from lacrimal gland inflammation. Clinical signs associated with this condition include mucoid ocular discharge, conjunctival hyperemia, ocular discomfort, and corneal vascularization and pigmentation. Chronic corneal ulcers and eventual blindness can occur in severe cases. Current treatment for KCS includes use of artificial tears to provide moisture to the ocular surface and immunosuppressants to decrease the inflammatory response that targets the lacrimal glands. While artificial tears provide relief, these must be administered frequently to be effective. In general, immunomodulating compounds must also be administered multiple times per day. A compound that could be given less frequently, but still be highly effective in treating KCS in dogs, could improve compliance, which may contribute to better treatment outcomes.


As part of both the Institute of Food and Agricultural Sciences and the Academic Health Center, Veterinary Medicine is dedicated to advancing animal, human and environmental health through teaching, research, extension and patient care.


Our Hospitals

Need animal care? Visit the UF Small Animal and Large Animal Hospitals. From dogs, cats, birds and exotics to horses, cattle, llamas, pigs and many other large farm or food animals, our experienced veterinarian staff is ready to assist.