Clinical therapeutics · 2026
Pharmacological Management of Dry Eye Disease: A Contemporary Landscape Analysis.
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Liu Chenxuan, Lou Junyi, Ma Lin, Luo Zining, Wang Runze, Chen Zongwei, Niu Jiahao, Liao Xuan
Аннотация
IMPORTANCE: Dry eye disease (DED) is a multifactorial ocular surface disorder affecting a substantial proportion of the global population. However, comprehensive landscape analyses of its pharmacological management remain limited.
OBJECTIVE: To characterize the clinical trial landscape within major public trial registries for DED pharmacotherapies and analyze trends in drug development, trial design, and geographic distribution.
DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional landscape analysis systematically examined 1003 interventional clinical trials registered on ClinicalTrials.gov and the Chinese Clinical Trial Registry from 1984 through October 23, 2025. Trials were categorized via a consensus-based framework that classified pharmacotherapies into seven therapeutic classes.
MAIN OUTCOMES AND MEASURES: The primary outcomes included trial characteristics (geographic distribution, phase, status, and design), drug classification frequency, and participant demographics.
RESULTS: Among the 1003 trials analyzed, artificial tears were the most studied intervention (386 trials, 38.5%), followed by ocular anti-inflammatory agents (280 trials, 27.9%). Novel and emerging therapies constituted the third largest category (95 trials, 9.5%). Trial registrations increased substantially after 2018, with a mean of 70.3 trials per year compared with previous years. The United States and China accounted for the majority of trial registrations. Most trials focused on adult populations, with parallel assignment being the predominant study design (91.2%).
CONCLUSIONS AND RELEVANCE: This landscape analysis describes the distribution and temporal patterns of registered clinical trials investigating pharmacological therapies for DED. By summarizing trial characteristics across therapeutic classes, study phases, and geographic regions, this review provides contextual information on the current structure of clinical trial activity, which may support future trial planning and research prioritization in this field.
OBJECTIVE: To characterize the clinical trial landscape within major public trial registries for DED pharmacotherapies and analyze trends in drug development, trial design, and geographic distribution.
DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional landscape analysis systematically examined 1003 interventional clinical trials registered on ClinicalTrials.gov and the Chinese Clinical Trial Registry from 1984 through October 23, 2025. Trials were categorized via a consensus-based framework that classified pharmacotherapies into seven therapeutic classes.
MAIN OUTCOMES AND MEASURES: The primary outcomes included trial characteristics (geographic distribution, phase, status, and design), drug classification frequency, and participant demographics.
RESULTS: Among the 1003 trials analyzed, artificial tears were the most studied intervention (386 trials, 38.5%), followed by ocular anti-inflammatory agents (280 trials, 27.9%). Novel and emerging therapies constituted the third largest category (95 trials, 9.5%). Trial registrations increased substantially after 2018, with a mean of 70.3 trials per year compared with previous years. The United States and China accounted for the majority of trial registrations. Most trials focused on adult populations, with parallel assignment being the predominant study design (91.2%).
CONCLUSIONS AND RELEVANCE: This landscape analysis describes the distribution and temporal patterns of registered clinical trials investigating pharmacological therapies for DED. By summarizing trial characteristics across therapeutic classes, study phases, and geographic regions, this review provides contextual information on the current structure of clinical trial activity, which may support future trial planning and research prioritization in this field.