Why is this study being conducted?
Local doctors are investigating the safety and effectiveness of two different doses of the study medication in patients with cornea disease.
Who can participate?
Doctors conducting this study are looking for men and women, 18 years of age and older, who have moderate to severe cornea disease.
What is known about the investigational drug?
The study medication is a topical drop that is applied to the eye. It has been tested in two earlier studies and has shown a tendency to be effective for some patients.
How will my privacy and safety be protected as a participant?
To protect your privacy, your name, address, phone number and other information that identifies you will not be shared with unauthorized individuals. For your safety, strict laws govern clinical studies, including this one. A process called informed consent ensures you receive all the facts about study participation prior to enrollment. To confirm that you understand study requirements and agree to participate, you will be asked to sign an informed consent document. This document is not a contract. You have the right not to participate in the study, even after signing the document. If you choose to participate, the clinical team will monitor your cornea disease throughout the study.
How long will I be in the study?
Up to eight weeks. There is a screening/washout period up to four weeks and a treatment period of four weeks.
Am I allowed to change my mind about participating?
Yes. Your participation in this study is voluntary, and you may withdraw for any reason at any time. You do not have to give a reason, and there is no penalty for leaving the study.
What will happen during the study?
Screening/washout: During this period, you will undergo a physical exam and other tests. If you are taking other medications, you might be required to stop taking one or more and not receive your first study treatment until one to four weeks later.
Treatment: You will visit the study clinic once every week for four weeks for treatment and evaluations. You will visit the clinic for an end-of-treatment visit.
Should I continue to see my primary health care provider while participating in this study?
Yes. The study team does not replace your primary health care team. Please let them know you are participating in this study, and continue to see them as needed.
May I continue to take other prescription medication?
In some cases, yes, but certain medications are not allowed during the study. Please tell the study team about all prescription and over the counter medications you take, including vitamins and herbal supplements. The study team will let you know which are allowed.