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To evaluate the safety and effectiveness of a new formulation of a topical drug, cyclosporine, currently used to treat Keratoconjunctivitis Sicca (KCS), commonly called "Dry Eye."
The causes of KCS include inherited, age-related, breed-associated and drug-induced. In most affected dogs the disease is incurable, requiring lifelong topical medications and, on occasion, surgery. KCS results in cummulative and often irreversible damage to the cornea leading to corneal scar, vascularization, pigmentation and vision loss. In addition, the disease can be chronically painful. Treatment has included topical artificial tear supplements, topical cyclosporine or tacrolimus and parotid duct transposition. The current standard of care would be topical cyclosporine or tacrolimus every 12 hours for the life of the dog. The current formulation of these medications are not water soluble and must be made in an ointment or oil-based form and are often compounded individually for each dog. Unfortunately, this formulation has limited bioavailability. The goal of this study is to evaluate a water-soluble form of cyclosporine which would be more user friendly for the owner, easier to administer and hopefully more bio-available, improving owner compliance and patient response. The water-soluble test drug will be compared to the same concentration of cyclosporine compounded in a traditional manner and delivered in an oil-based vehicle. If this formulation of cyclosporin is effective, it will have implications for other immune and inflammatory corneal diseases in animals (dog, cat, horse) and humans and may have benefit for cyclosporin- responsive intraocular diseases such as immune-mediated uveitis (human, dog, horse).
To qualify for enrollment in this study, dogs must:
Dr. David Wilkie, wilkie [dot] 1 [at] osu [dot] edu or Dr. Anne Metzler, metzler [dot] 134 [at] osu [dot] edu, or call 614-292-3551 for further information.