Data capture in traditional ophthalmic clinical trials can be inflexible and infrequent, making it difficult for researchers to monitor patients’ disease activity and capture real-world patient experiences. FocalView aims to help patients complete various assessments, gaining feedback on their visual function, including any changes over time. At the same time, the app could provide researchers with a greater volume of real-world, patient-reported data, creating more flexible and accessible clinical trial designs.
“Because patients with eye diseases are often not as mobile, FocalView has the potential to offer tremendous benefit for the ophthalmic community and for researchers looking to develop better treatments for these patients,” said Dr. Mark Bullimore, medical adviser for the creation of FocalView and dean of the Southern California College of Optometry at Marshall B. Ketchum University. “Collating validated patient-reported outcomes in clinical trial research is no longer a nice-to-have. This kind of data is fast becoming a critical element of research and development, because it offers a better reflection of real-world patient experiences, fosters better patient compliance and provides researchers with richer and more accurate data points.”
FocalView will be tested in a prospective, noninterventional study to evaluate the app’s efficacy and usability in assessing visual function. These measurements include visual acuity and contrast sensitivity. Researchers will in turn assess ease of use, level of enrollment and the ability to obtain important documentation for future clinical trial research, such as informed consent. In the next phase, the app will be validated against traditional visual testing that takes place within conventional clinical settings.
“Optimizing digital technology in research and development, particularly in ophthalmic disease, could have a marked impact on the quality of the data we capture,” said Novartis chief digital officer Bertrand Bodson. “We believe apps like FocalView, which we’ve made freely available to the research community on an open-source platform, can help accelerate the development of treatments and bring them to the patients who need them most.”
FocalView is now available for download from the App Store in the U.S. Consent to contribute to research data will be required before a user can interact with the tool. Novartis is planning to launch it in additional markets in the future.