Frequently Asked Questions

1. What is a clinical trial/study?

As with new medications for people, new animal drugs must be tested in studies for safety and effectiveness.  These studies are then evaluated by the FDA (Food and Drug Administration) to determine if the new animal drug will be approved.

2. What is the purpose of this study?

This specific study is being conducted to test a new topical medication for dogs with certain types of early ear problems with the goal of achieving FDA approval.

3. What are the benefits of participating in this study to me and my dog?

There are several benefits, such as:

  • Everything required by the study is free, including:
    • Veterinary exams
    • Diagnosis of the ear condition via microscopic evaluation
    •  Treatment with test medication or placebo
  • Appropriate ear care to help your dog
  • Your dog may help other dogs in the future by advancing veterinary science

4. If I participate with my dog, what will I need to do?

The study requires just one week of your time. If you agree to participate, you’ll need to:

  • Bring your dog to the clinic for the two scheduled visits (at the beginning and end of the study)
  • Administer the topical treatment in your dog’s ears once daily for 7 days, and follow the study veterinarian’s instructions
  • Monitor your dog at home and report how your dog is doing to the study veterinarian

5. What are the eligibility requirements for my dog?

Dogs must:

  • Be at least 4 months of age
  • Be manageable and cooperative in a clinic setting
  • Not be pregnant, lactating, or actively breeding
  • Pass the veterinarian’s general health evaluation
  • Not be currently receiving treatment for the ear problem
  • Meet other criteria that will be reviewed with you at the veterinary clinic

6. What are the signs of ear problems in dogs?

Ear problems are very common in dogs, and the early signs necessary to qualify for this study may include:

  • Head shaking
  • Showing signs of itching, such as rolling on back on the floor or ground
  • Rubbing against things (such as on furniture or rugs)
  • Redness in or on the ears

7. Can ear problems be dangerous?

Ear problems should never be ignored. In addition to being uncomfortable and even painful for your dog, left untreated, ear conditions can lead to serious consequences, including deafness, loss of balance, incoordination, and uncontrollable shifting eye movements known as nystagmus.

8. How do I get started?

Once you’ve reviewed the preliminary study qualifications for screening and think your dog may be eligible, complete this brief form to learn if your dog may qualify for screening.

Upon completion of the form, if it appears your dog may qualify, you will be given the phone number for the participating study veterinarian near you. You’ll be asked additional questions to help determine if you should bring your dog in for a screening appointment.

9. Are there any risks involved to my dog?

As with all medications, there are risks and benefits.  The study veterinarian will review these with you prior to you giving consent to enroll your dog.

10. What if my dog is screened but doesn’t qualify for the study?

The study veterinarian will recommend appropriate care to help your dog.

11. Are there any costs involved?

Everything required by the study, including all diagnostics, exams, and topical medications, are paid by the study sponsor.

12. What if my dog receives the placebo?

There is a 50% chance that a participating dog will receive a placebo (topical ear solution with no medication in it).  The study is masked and even veterinary clinic team members do not know which dogs receive the test medication or the placebo.  This double-blind, placebo-controlled approach is considered the gold standard for clinical studies, helping to ensure that improvements in patient outcomes are valid and conclusive, and not influenced by anyone involved.

If your dog does not respond to study treatment during the study, the veterinarian will discuss alternative care to help your dog.

13. Who is paying for the study?

A major animal health pharmaceutical company is sponsoring the study. 

14. What if I enroll my dog and then decide I no longer wish to participate?

We hope owners will keep their dogs enrolled for the one-week duration of the study, but you may opt out at any time for any reason.

Frequently Asked Questions

1. What is a clinical trial/study?

As with new medications for people, new animal drugs must be tested in studies for safety and effectiveness.  These studies are then evaluated by the FDA (Food and Drug Administration) to determine if the new animal drug will be approved.

2. What is the purpose of this study?

This specific study is being conducted to test a new topical medication for dogs with certain types of early ear problems with the goal being FDA approval.

3. What are the benefits of participating in this study to me and my dog?

There are several benefits, such as:

  • Everything required by the study is free, including:
    • Veterinary exams
    • Diagnosis of the ear condition via microscopic evaluation
    •  Treatment with test medication or placebo
  • Appropriate ear care to help your dog
  • Your dog may help other dogs in the future by advancing veterinary science

4. If I participate with my dog, what will I need to do?

The study requires just one week of your time. If you agree to participate, you’ll need to:

  • Bring your dog to the clinic for the two scheduled visits (at the beginning and end of the study)
  • Administer the topical treatment in your dog’s ear(s) once daily for 7 days, and follow the study veterinarian’s instructions
  • Monitor your dog at home and report how your dog is doing to the study veterinarian

5. What are the eligibility requirements for my dog?

Dogs must:

  • Be at least 4 months of age
  • Be manageable and cooperative in a clinic setting
  • Not be pregnant, lactating, or actively breeding
  • Pass the veterinarian’s general health evaluation
  • Not be currently receiving treatment for the ear problem
  • Meet other criteria that will be reviewed with you at the veterinary clinic

6. What are the signs of ear problems in dogs?

Ear problems are very common in dogs, and the early signs necessary to qualify for this study signs may include:

  • Showing signs of itching, such as rolling on back on the floor or ground
  • Rubbing against things (such as on furniture or rugs)
  • Head shaking
  • Redness in or on the ears

7. Can ear problems be dangerous?

Ear problems should never be ignored. In addition to being uncomfortable and even painful for your dog, left untreated, ear conditions can lead to serious consequences, including deafness, loss of balance, incoordination, and uncontrollable shifting eye movements known as nystagmus.

8. How do I get started?

Once you’ve reviewed the preliminary study qualifications for screening and think your dog may be eligible, complete this brief form to learn if your dog may qualify for screening.

Upon completion of the form, if it appears your dog may qualify, you will be given the phone number for the participating study veterinarian near you. You’ll be asked additional questions to help determine if you should bring your dog in for a screening appointment.

9. Are there any risks involved to my dog?

As with all medications, there are risks and benefits.  The study veterinarian will review these with you prior to you giving consent to enroll your dog.

10. What if my dog is screened but doesn’t qualify for the study?

The study veterinarian will recommend appropriate care to help your dog.

11. Are there any costs involved?

Everything required by the study, including all diagnostics, exams, and topical medications, are paid by the study sponsor.

12. What if my dog receives the placebo?

There is a 50% chance that a participating dog will receive a placebo (topical ear solution with no medication in it).  The study is masked and even veterinary clinic team members do not know which dogs receive the test medication or the placebo.  This double-blind, placebo-controlled approach is considered the gold standard for clinical studies, helping to ensure that improvements in patient outcomes are valid and conclusive, and not influenced by anyone involved.

If your dog does not respond to study treatment during the study, the veterinarian will discuss alternative care to help your dog.

13. Who is paying for the study?

A major animal health pharmaceutical company is sponsoring the study. 

14. What if I enroll my dog and then decide I no longer wish to participate?

We hope owners will keep their dogs enrolled for the one-week duration of the study, but you may opt out at any time for any reason.