Veterinary Medical Center

Purpose of Study

The goal of this study is to evaluate ZP-1 (P-1046) is a topical ophthalmic prescription pharmaceutical product for the treatment of canine keratoconjunctivitis sicca that is administered as a twice per day topical eye drop. 

 Background

Keratoconjunctivitis sicca (Dry Eye) is a common ophthalmic disease that affects humans and dogs.  The prevalence of dry eye in humans is reported to be 14%.  In animals, the American Cocker Spaniel is the most commonly affected breed with a prevalence of 20%.  The overall prevalence of dry eye in the canine has been reported to be 4%.

The causes of canine dry eye are numerous and 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.  Dry eye 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 various topical artificial tear supplements, topical cyclosporine or tacrolimus and parotid duct transposition. The current standard of care would be viscous artificial tears at variable frequency and topical cyclosporine or tacrolimus every 12 hours for the life of the dog.

Extensive preclinical studies have demonstrated that the ENaC blocking mechanism of this class of compounds is robust and durable in various mucosal surface applications. As a result, several ENaC inhibitor compounds are also in development for human indications such as cystic fibrosis, xerostomia and dry eye.

 Inclusion criteria

To qualify for enrollment in this study, dogs must:

• Have a confirmed diagnosis of KCS (STT <15mm/mm)
• Be treatment-naïve 

Study Design

 Pre-study:

• A routine complete ophthalmic examination will be performed.
• Animals with a STT less than 15 mm/min that are not currently being treated with cyclosporine or tacrolimus will be considered eligible for study enrollment. 
• Photographs will be taken prior to study initiation.
• Study drug and I-Drop Vet Plus® will be provided to the owner at no cost and the cost of all ophthalmic examinations at OSU during the study will be paid for by the study sponsor.
• The owner, will complete a questionare at presentation and at initiation and 14 days of the study.

 Day 14:

• A routine complete ophthalmic examination will be performed.
• The owner will complete a questionare 

 Client Compensation

The sponsor will cover all study associated costs as well as provide clients with a $300 preloaded credit card at the completion of the study.

 Contact Information

Please contact the Clinical Trials Office at the Veterinary Medical Center for more information about this study.