Information For Patients
What is Clinical Research?
Clinical research, also sometimes referred to as clinical studies or trials, is a branch of healthcare that is designed to determine safety and effectiveness of medications, devices, or diagnostic tools intended for human use. This is how healthcare develops and learns information about new and approved medications or devices.
Clinical Trials have four phases to test new treatments, find appropriate dosage, and learn about potential side effects.
- Phase I – testing in healthy participants to find appropriate dose range
- Phase II – testing completed in patients to assess safety (side effects) and efficacy in a small population of patients; 100-300
- Phase III – testing for efficacy, effectiveness, and safety (side effects) in a larger population of patients; 300-3,000
- Phase IV – testing in post marketing/approval use for additional medication information on safety, efficacy, and effectiveness
Why do people participate in trials?
- New treatment therapies: Some patients state that they will participate so that they have access to a new treatment that is not yet on the market or approved for their condition.
- Benefits for future patients: Many of our patients tell us that they participate to help provide future patients with new medications or treatments for their condition.
- Financial benefits: Many trials offer patients the ability to manage conditions and see the study doctors free of charge. The new study medications are often also provided without any cost to the participants, which saves money from the standard medications they would have to purchase. Some trials also provide a monetary compensation for time spent at the clinic for study visits.
Are there any risks in the study?
All medications, including approved over-the-counter or prescription, have potential risks or side effects. All of the potential medication side effects or medical risks are detailed in an informed consent document. The informed consent document is reviewed with you prior to your decision to participate in the study. You are encouraged to ask any questions and have all of your concerns addressed prior to making any decisions to participate in the study. If you have additional questions or concerns during your study, you are always encouraged to discuss these with the study manager or any of the study doctors.
How long will the clinical trial be?
Each study will vary in length for the trial, number of visits, and duration of each visit. This information is detailed in the study informed consent document and will be discussed prior to your decision to participate.
Will my study have placebo?
Placebo is an inactive formulation of the medication being studied. Placebo is often used in clinical studies to compare the effectiveness to the new investigational medication. Patients will sometimes be randomized to receive a placebo medication and will be detailed in the informed consent for each study.
Should I still see my regular eye doctor or medical doctor?
Yes. We encourage you to continue to see your primary optometrist/ophthalmologist and medical health care providers and to notify them of your decision to participate in the trial. It is also important that they are aware of your participation so that we can all ensure that any changes to your medications remain within the trial guidelines.
What treatment will I have after the study is complete?
The study medication used in your trial will not be available after the study is complete, unless it is already approved by the FDA.
If you have another primary care physician, you should discuss treatment options with them after the study is complete. If you do not have a primary care physician and would like to continue to see our providers, we are happy to help make arrangements.
Can I leave the study after I’ve started?
Yes. You may change your mind about the study after you have started; however, please inform our staff of your desire to end participation. Please also know that some studies still require follow-up activity(ies) to be completed.
Can I do another clinical study trial?
Once you complete your current trial and if we have an additional study for your condition, you can request to see if you would be eligible for a new study. Please note that there is usually a 30-day waiting period between studies and you cannot be in more than one study at a time.
How do I sign up for a study?
In order to determine if you are eligible for a study, you will need to complete a screening appointment. Once the screening appointment is complete, we will be able to tell you if you qualify for the study or if there is another study in which you would qualify. If you do not qualify for any of our current trials, we can add you to our research database and contact you when additional trials for your condition are available.