A comprehensive analysis of dry eye disease clinical trials (2000–2024): research trends and gaps

These commonly used endpoints vary in psychometric validity and standardization, which can undermine data quality, complicate analysis and interpretation of individual trial results, and limit cross-trial comparability. Overall, the ecosystem appears mature but conservative, emphasizing later-phase, single-agent studies, traditional endpoints, and limited severity stratification and geographic diversity. Future trials should prespecify severity and subtype strata, use validated mechanism-aligned endpoints with standardized assessment windows and longer follow-up, and broaden geographic representation to improve generalizability and cross-trial comparability.