Alcon conducts clinical trials to evaluate the safety and efficacy of our products. These clinical studies are fundamental to driving innovation and developing products to prevent blindness and treat conditions and diseases of the eye.
A clinical trial, also referred to as a clinical or research study, allows doctors and researchers to gain information on the benefits, side effects, and possible applications of new drugs and devices. In addition, it also helps determine appropriate combinations, doses and new indications of existing drugs. As a result, we are able to find new ways to detect, diagnose, avoid and control clinical factors responsible for eye diseases.
Four Phases of Clinical Trials
Clinical trials commonly occur in four phases. If a product successfully passes through the first three trial phases, it is submitted for approval to regulatory organizations for use in the general population.
Phase I – This is the first use of a drug, device or instrument in a small group of humans to test for safety and side effects, and to determine how the product should be used or delivered.
Phase II – This is initiated amongst a larger number of patients to investigate the ideal dosing range or usage parameters of the potential product. Testing is also conducted to determine other possible, less common side effects.
Phase III – For pharmaceuticals, this phase is used to compare treatments to a placebo in order to determine effectiveness in a large patient population. Phase III study results are the foundation for regulatory filings that are submitted for approval. For ophthalmic surgical devices, the surgical impact and results are measured and reported to regulatory bodies for evaluation.
Phase IV – This phase may be conducted for continued evaluation after regulatory approval to improve safety and effectiveness of therapies already available for general use.
To learn more about current clinical trials, as well as Investigator Initiator Studies, please visit myalcon.com.
Completed Alcon Clinical Trials
Alcon recognizes the importance of informing the public about clinical trial results, regardless of the outcome. In alignment with Novartis policies, Alcon has taken several important steps to ensure that information about clinical trial results reach the public in a timely and balanced manner.
The results of our clinical trials are publicly available through peer-reviewed publications and posting of results at ClinicalTrials.gov. Knowing the results of these trials enables both patients and eye care professionals to make well-informed decisions regarding treatment benefits and risks.