Novartis app could revolutionise ophthalmic clinical trials

Patients will be able to participate in clinical ophthalmology trials from home thanks to a groundbreaking digital app developed by Novartis.

The FocalView app, which will enable patients with mobility issues to take part in clinical trials, means researchers can study and collect data about eye diseases regardless of a person’s location.

Patients will be able to record their own measurements, which will hopefully mean new treatments are developed and subsequently brought to market more rapidly.

Traditional ophthalmic trials face challenges due to the practical issues faced by patients, making data capture inflexible and intermittent. The unpredictability caused by the latter has historically meant that researchers are unable to capture real-world information relating to the diseases.

Once users have consented to contribute to the research, the app will prompt patients to complete assessments on their visual function and ask them to detail any changes over time. In the first instance, FocalView will be tested in a prospective, non-interventional study.

Its effectiveness in assessing visual function – including visual acuity and contrast sensitivity – will be assessed.

Dr Mark Bullimore, medical advisor for the creation of FocalView and dean of the Southern California College of Optometry, Marshall B. Ketchum University, said: "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."

"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."

Ease of use, level of uptake and the capacity to obtain documentation for future clinical trial research, such as informed consent, will be monitored. The results of the app will also be compared to traditional visual testing that takes place in conventional clinical settings.

FocalView is available from the US App Store with additional markets to be added in future. The findings made via FocalView will be freely accessible via the Apple ResearchKit platform.

Last month, Novartis announced plans to begin up to 10 clinical trials over the next three years with Science 37, which develops decentralised clinical trial technology so certain aspects of the trial can be carried out in a patient’s home or by their GP.