How will you protect my health while I am in the study? The outline of the Clinical Trial is based on protecting your safety and privacy. There will be many monitoring visits, which are designed to monitor your ocular health and ensure that the study drug is not negatively affecting you in any way. If this were the case, the PI may withdraw you from the study to protect your ocular health. Other health measures such as blood pressure, SpO2, temperature, and heart rate, amongst others, may also be collected. In addition to this, you can contact one of our staff for assistance or alerts 24/7 throughout the study.
What happens if my health problem gets worse during the study? You have the right to withdraw from the study at any stage. If you do not withdraw yourself, the Investigator may discontinue you from the study if he/she believe that you or your ocular or systemic health is in any way compromised by continuation of the study.
Can I take my regular medicines while in the trial? Some clinical trials do allow you to continue to take your own eye drops through the duration of the clinical trial. However, most trials will not allow for this. All Clinical Trials will allow for you to continue to take any medications you need for anything else you may have, given that you are willing to disclose this information to the study team. These medications will be written in your source as part of your medical history/concomitant medications. This is both for your safety and for data efficacy.
Who will be in charge of my care while I am in the study? Will I be able to see my own doctor? The Principal Investigator will be in charge of your care. You will of course, be able to see your own doctor and talk to them about the trial. Your doctor will not be able to perform study-related assessments or be unmasked (see if you are on the experimental treatment or placebo). Your doctor will be unmasked if there is an ocular Adverse Event warranting his/her unmasking.
How will you keep my doctor informed about my participation in the trial?If you would like/consent to, we will send your doctor any relevant trial information. This option is given to you at the time of signing the patient informed consent form.
If I withdraw, will this affect my normal care? Not at all, you are free to withdraw at any stage with or without a reason. Your normal care will not be affected.
