The goal of the study is to evaluate the effectiveness and side effects of a potential new treatment option, AZR-MD-001 (an ointment applied to the lower eyelid), applied twice weekly for 12 months, compared to a *placebo, in volunteers with abnormal meibomian gland function and associated symptoms of Dry Eye Disease (DED).
Approximately 500 volunteers with Dry Eye Disease (DED) symptoms and evident Meibomian Gland Dysfunction (MGD) will be recruited across the United States. You may not realize you have MGD and the study team and physician will evaluate your eyes through a variety of assessments to determine if you do. If so, you may be eligible to participate!
The study will last about 13 months and includes up to nine in-clinic visits. Eligible participants may receive up to $2,000 in compensation for completing nine study visits. Reimbursement for transportation by car service (i.e., Uber, Lyft, Taxi) may be available.
To determine your eligibility, please complete the form below. Our patient recruitment team will contact you to ask more questions and provide more information about the study.
(A *placebo is a substance or treatment without real medical effects and is often used in studies to compare against the real treatment.)
You may qualify to participate if you:
Are 18 years or older
Are experiencing symptoms of Dry Eye Disease (DED) in both eyes for at least 3 months
Have evidence of Meibomian Gland Dysfunction (MGD) confirmed by the study team
Are willing to discontinue the use of:
If you qualify for this study, here is what you can expect:
During these visits, you will go through a series of assessments, including:
In addition, there are other assessments that the study team will discuss with you in detail during your screening visit.
We are currently conducting this study nationwide, with new locations coming soon. Take a look at our current locations below to find out if we have a study location near you.
The study will last approximately 13 months and involves up to 9 in-person visits.
Taking part in any clinical study is entirely voluntary. Your decision whether or not to participate will not affect the medical care you currently receive or may receive in the future. If you qualify and opt to join the study, you have the freedom to withdraw at any time and for any reason.
Study medication and all study-related testing will be provided to you by the sponsor (Azura) at no
charge; however, taking part in this study may lead to added costs to you and/or your insurance company.
Tests and procedures that are routine care for your eye condition (not part of this research study) will be billed
to your insurance.
Your personal and medical information is completely protected before, during and after the clinical trial process through the HIPAA (Health Insurance Portability and Accountability Act) Privacy Rule. You will also be informed of who has access to your personal information.
Azura Ophthalmics is responsible for conducting this clinical study.
Key Inclusion Criteria
Key Exclusion Criteria
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