Differential Sex-Based Enrolment into US-Registered Glaucoma Clinical Trials: A Cross-Sectional Study

We conducted a cross-sectional study of sex, racial, and ethnic patient enrolment to glaucoma-related randomized controlled trials (RCTs) registered on ClinicalTrials.gov (to January 2023).

Trials were included if they were at least double-masked, completed, and had published results through the registry or a scholarly journal. Sex-based glaucoma disease burden was identified using the Global Burden of Disease database. Pooled population-to-prevalence ratios (PPRs) with 95% confidence intervals (CI) were calculated for female sex, with values between 0.8 and 1.2 constituting sufficient study enrolment.

From 1061 records, we identified 177 trials (N = 38.475; 56.2% females) for inclusion in the study. The pooled female PPR was 1.05 [95% CI 1.02, 1.08]. Sub-group analysis revealed equitable female enrolment across study characteristics, although studies published prior to 1997 were indeterminate on whether they under-enrolled female participants.

Overall, US-registered, glaucoma-related trials enrolled acceptable proportions of females based on real-world disease burden. Future trial enrolment should strive for equitable demographic representation.