A clinical trial is only done when there is some reason to believe that the treatment being studied may be of value to the patient. Treatments used in clinical trials are often found to have real benefits. The purpose of a Phase I study is to find the best way to give a new treatment and how much of it can be given safely.
Physicians watch patients carefully for any harmful side effects.
The research treatment has been well tested in laboratory and animal studies, but the side effects in patients are not completely predictable. Phase II trials determine the effectiveness of a research treatment after safety has been evaluated in a Phase I trial. Patients are closely observed for an anti-keratoconus effect by careful measurement of KC sites present at the beginning of the trial. In addition to monitoring patients for response, any side effects are carefully recorded and assessed. Phase III trials require entry of large numbers of patients.