Publication Rates of Registered Corneal Trials on ClinicalTrials.gov

Abstract

Purpose:This study aimed to characterize cornea-centered clinical trials, completed before 2020, registered on ClinicalTrials.gov and identify discrepancies in publication.Methods:ClinicalTrials.gov, a database from the National Institutes of Health, was queried to identify registered cornea-related clinical trials. Trials were included if they were interventional and completed before January 1, 2020. ClinicalTrials.gov, PubMed.gov, and Google Scholar were then searched to evaluate publications from the trial. Data collected for each trial included sponsor, intervention type, phase, dry eye focus, and location of the principal investigator.Results:A total of 520 trials were included in the final analysis. Of all studies, 270 (51.9%) were found to have published results. Industry-sponsored studies were associated with drug intervention trials, dry eye focus, and the principal investigator's location within the United States (P< 0.05 for all). Nonindustry sponsors were associated with device and procedure intervention trials (P< 0.05 for both). Overall, trials that were categorized as procedure interventions were published at a significantly higher rate than other interventional categories (64.2% vs. 50.1%;P= 0.03). Subgroup analysis revealed that among nonindustry studies, late-phase trials and procedural-based trials were published at a significantly higher rate compared with other studies (67.2% vs. 51.6%;P= 0.04 and 67.8% vs. 51.6%;P= 0.03).Conclusions:Only 51.9% of registered interventional cornea-based clinical trials result in publications in the peer-reviewed literature, highlighting potential publishing discrepancies.