AAOpt 2024: Running the numbers on ophthalmic clinical trials

Optometrists are well-aware of the critical role clinical trials play in advancing eye care treatments and technologies. However, one of the most common challenges faced in these trials is meeting enrollment targets within the desired timelines. At the 2024 American Academy of Optometry meeting in Indianapolis, Indiana, Andrew Pucker, the Executive Director of Clinical and Medical Science at Lexitas Pharma Services, presented valuable data on enrollment rates and trends in the North America region, offering key insights for optometrists involved in clinical research.

Pucker's team conducted a comprehensive analysis of every clinical trial registered in the United States, breaking down the data by study phase and common ophthalmic indications, such as glaucoma, dry eye, and macular degeneration. This level of granularity is invaluable for researchers and sponsors planning new trials, as it provides realistic benchmarks for enrollment, site requirements, and study duration. For example, the data revealed that a typical phase 2 dry eye study requires approximately 100 subjects and 20 clinical sites, with an average completion time of 6 months. Armed with this information, researchers can more accurately forecast resource needs and budgets, ultimately improving the chances of successful enrollment and timely study completion.

Beyond the specific metrics, Pucker's analysis also highlighted the dominance of certain industry players in the ophthalmic clinical trial landscape. Alcon and Allergan emerged as the most prolific sponsors, underscoring their commitment to advancing eye care innovations. This knowledge can help optometrists identify potential collaborators and stay abreast of the latest developments in their respective fields.

Pucker's work serves as a valuable resource for the optometric community, bridging the gap between the theoretical and practical aspects of clinical research. By understanding the nuances of enrollment trends and sponsor activities, optometrists can better position themselves to participate in cutting-edge trials, contribute to the advancement of eye care, and ultimately, provide their patients with access to the most promising treatments. The full dataset and analysis are available in the Optometry and Vision Science journal, and Pucker has graciously offered to share his presentation poster with interested parties. As we continue to navigate the evolving landscape of ophthalmic clinical trials, this information can prove instrumental in optimizing enrollment, streamlining study design, and driving innovation in the field of eye care.