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Outcomes Measures and Metrics Used and Clinical Results of Trials for Sjogren's versus Non-Sjogren's Dry Eye
Kyle Munar, BA
Presenter:
Kyle Munar, BA, , Priyanka K. Ramulu, David Cui, MD, Esen Akpek, MD
Authors:
Affiliation:
1. Foster Ocular Immunology and Inflammation Center, Duke University School of Medicine, Durham, North Carolina, USA
2. Foster Ocular Immunology and Inflammation Center, Duke University School of Medicine, Durham, North Carolina, USA
Purpose: To compare the outcome measures and metrics used and the clinical results reported in regulatory trials of the United States (U.S.) Food and Drug Administration (FDA)-approved therapeutics for the treatment of dry eye disease (DED).
Clinical Relevance: The growing number of prescription DED medications necessitates interpreting the nuances of each medication and determine comparative effectiveness for optimal prescribing. To date, there are no head-to-head clinical trials evaluating these medications, nor is there a regulatory requirement for comparative studies as part of the approval process. Consequently, clinicians must rely on indirect comparisons and individual studies when selecting therapy. By summarizing clinical outcomes from regulatory trials, this study attempts to guide appropriate treatment selection.
Methods: We conducted a retrospective review in September 2025 of publicly available published sources, including the FDA database, application review files, ClinicalTrials.gov, and peer-reviewed articles. Eligible studies were phase IIb and III randomized, masked clinical trials of FDA-approved topical DED treatments that provided the foundation for regulatory approval. From each trial, we extracted details regarding study design, interventions, and physician-measured clinical outcomes related to ocular surface (corneal fluorescein and conjunctival lissamine green staining score) and tear film (tear production and tear stability) parameters.
Results: Nineteen clinical trials were included and the results were tabulated. Significant heterogeneity was noted among clinical trials with regards to study characteristics. Comparisons were made only when medications evaluated the same endpoint using the same test and metric.
Conclusion: Heterogeneity among the studies hindered the ability to perform direct cross-study comparisons. As a result, few meaningful cross-medication comparisons were feasible. This review underscores the need for validated clinically meaningful DED outcomes measures and standardized trial methodologies to advance the development of therapeutics in the field of DED, facilitating cross-study comparisons, and ultimately improving patient-centered care.