Outcome Measures and Clinical Results of Trials for United States Regulatory Approval of Dry Eye Therapeutics.

Authors

Kyle C Munar, Priyanka K Ramulu, David Cui, Esen K Akpek

Published in

Cornea. Jul 28, 2026. Epub Jul 28, 2026.

Abstract

To describe the outcome measures, metrics used, and clinical results reported in regulatory trials of the US Food and Drug Administration-approved therapeutics for the treatment of dry eye disease.
For each trial, data were extracted regarding study design, interventions, and physician-measured clinical outcomes related to ocular surface (corneal and conjunctival vital dye staining score) and tear film (tear production and tear stability) parameters. Main outcome measures details of clinical assessment methods and characteristics of trial patients.
Results from 19 trials were included. Reported efficacy end points varied considerably and included Schirmer test, performed with or without topical anesthesia, and analyzed using 2 distinct metrics: mean change from baseline at the final study visit, or responder analyses defined as the proportion of participants achieving a ≥10-mm increase from baseline. Measures of tear film stability were assessed using fluorescein tear film break-up time, with outcomes reported as mean change from baseline in seconds. Ocular surface damage was evaluated through corneal and conjunctival vital dye staining, using 4 different corneal and 3 different conjunctival grading scales, with results expressed as mean change from baseline in total staining scores. Some studies reported corneal staining responder analyses, defined as the proportion of participants achieving a ≥3-grade improvement from baseline.
Heterogeneity among the included studies hindered direct cross-study comparisons, resulting in few meaningful cross-medication comparisons. This review underscores the need for validated, clinically meaningful dry eye disease outcome measures and standardized trial methodologies to advance therapeutic development and facilitate robust cross-study comparisons.

PMID:
42561040
Bibliographic data and abstract were imported from PubMed on 07 Aug 2026.

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