Click here to download the study flyer
Purpose and Brief Explanation of Study:
Dry eye is a common chronic disease that affects both humans and dogs and causes progressive damage to the cornea leading to corneal scars, corneal vascularization, corneal pigmentation, pain, and ultimately vision loss. Causes of dry eye include immune-mediated, congenital, age-related, post inflammatory, and drug-induced.
Treatments for dry eye include various topical medications such as tear supplements, steroids, cyclosporine or tacrolimus (immunomodulatory drugs), as well as surgical efforts such as parotid duct transposition. In order to maintain vision and comfort, dogs with dry eye are often managed with one or more of these topical medications twice daily lifelong.
While it may seem that there are many options for dry eye treatment, the majority of these topical medications are aimed at the immune-mediated component of dry eye and can be ineffective for dry eye caused by other etiologies. In addition, currently there is only one FDA approved product (0.2 % cyclosporine) on the market for dry eye in dogs, which often requires treatment for up to 12 weeks before clinical improvement is seen. Furthermore, some dogs do not respond or become refractory to this treatment and practitioners often resort to compounded and off-label medications. For these reasons, an alternative topical treatment which is effective for all causes of dry eye is expected to have a desirable impact on the treatment of dry eye in dogs.
Objective of the trial:
The objective of this study is to evaluate the relative effectiveness of D929 when applied topically to the eye at various dose levels under field conditions in dogs with dry eye. This will be accomplished by comparing the Schirmer Tear Tests (STT), Tear Breakup Time (TBUT), and Clinical Observation scores following daily administration of D929 over a 45 day period. A STT involves placing a paper strip into the lower eyelid pocket and measuring the distance tears wick onto the strip in one minute. A normal value is greater than or equal to 15 mm/minute. A TBUT involves applying a drop of a green fluorescein dye to the eye and measuring how long it takes for the tear film to start to break up on the surface of the cornea. A normal TBUT is greater than or equal to 20 seconds. These tests are routinely performed in canine patients to evaluate for dry eye conditions and do not cause any significant discomfort to the patient. Clinical Observation scores are recorded from a routine ophthalmic examination.
What qualifies my dog for enrollment in this in this trial?
To participate in this clinical trial your dog must:
- Have a diagnosis of dry eye (STT > 5 mm/min and <15 mm/min)
- Not been treated for dry eye with cyclosporine, tacrolimus or parotid duct transposition at any time prior to the study
- Not been treated with topical ocular medication other than artificial tear supplements 2 weeks before enrollment.
- Be generally health with no other concomitant diseases, including ocular disease.
What does enrolling my dog in this clinical trial involve?
If your dog enrolls into the clinical trial, your veterinarian will ask you to come back to the veterinary medical center 4 more times: at Days 7, 14, 30, and 45 after the first visit. An examination of your dog will be performed during each visit. These exams aim to verify the effectiveness and safety of the drug.
Your dog will receive D929 or placebo. The active ingredient in this product is being developed for use in dry eye in both humans and animals. The drug D929 is in a topical eye drop form. The D929 eye drop should be kept refrigerated at all times when not in use.
You will administer 1 drop in the affected eye(s) once or twice daily according to your Treatment Dispenser’s instructions. If the drops are given twice daily, there should be at least 8 hours and at most 12 hours between doses. Drops should be applied around the same time of day every day.
There will be no cost to you for having your pet participate in the study. All medications, examinations, and medical care related to this study (related to the ocular disease) will be provided to your pet at no cost during the study period.
Pet owners will receive $100 gift card or credit after the dog completes or is removed from the study for completion of all appropriate scheduled visits and follow-up phone calls.
If you believe your pet may be eligible to enter this study, please click here to fill out a questionnaire, or please contact the Blue Buffalo Veterinary Clinical Trials Office at CVM-ClinicalTrials@osu.edu