ENRICHED trial of preservative-free lubricants in dry eye disease

We evaluated the effectiveness, adherence, and safety of preservative-free (PF) lubricants in adults with dry eye disease (DED) under real-world clinical conditions. The ENRICHED-PF trial (NCT06162442) was a single-arm, prospective interventional study conducted in Cali, Colombia. A total of 120 adults with mild-to-moderate DED initiated PF propylene glycol 0.3% / polyethylene glycol 0.4% drops for six months. Longitudinal analyses were performed using linear mixed-effects models, with multiple imputation applied under a Missing at Random assumption to handle missing data. At baseline, the median Ocular Surface Disease Index (OSDI) score was 31.2 [19.2-47.4]. Longitudinal model-based estimates showed an OSDI estimated marginal mean (EMM) of 33.9 at baseline, 23.1 at 3 months, and 16.8 at 6 months in the mITT population, corresponding to an estimated change of - 17.1 points at month six (p < 0.001), with 65.4% of the modified intention-to-treat (mITT) population and 58% of the per-protocol (PP) population achieving a clinically meaningful response (≥ 10-point improvement). Tear break-up time increased and corneal staining scores decreased (both p < 0.001), while Schirmer I values remained stable. Additionally, NEI VFQ-25 composite scores improved by 8.9±3.1 points (p<0.001). These findings suggest clinically meaningful improvements in symptoms, tear film stability, and ocular surface integrity over time, which were associated with treatment using PF lubricants. However, given the single-arm design, the absence of a comparator group, and loss to follow-up during the study period, the magnitude of these effects should be interpreted with caution and confirmed in controlled comparative studies.Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT06162442.