Allergan, an AbbVie company, Irvine, California, USA.
School of Optometry, University of Alabama at Birmingham, Birmingham, Alabama, USA.
J Ocul Pharmacol Ther. 2023 Nov;39(9):611-621. doi: 10.1089/jop.2023.0064. Epub 2023 Aug 29.
Dry eye disease is attributed to impaired tear production and/or evaporative dry eye. Evaporative dry eye is frequently associated with meibomian gland dysfunction (MGD). The objective of this study was to identify clinical study endpoints related to MGD. This 22-day, noninterventional, case-control clinical study involved three cohorts with increasing MGD severity: no MGD, mild/moderate MGD, and severe MGD. Symptoms were assessed with an ocular symptom questionnaire grading blurred vision, eye burning, eye dryness, eye pain, light sensitivity, eye itching, eye foreign body sensation, and overall ocular discomfort. Sign assessments included the maximum meibum quality score (MMQS), tear breakup time, Schirmer tear tests, biomicroscopy, and corneal staining. Signs and symptoms were compared between cohorts and study visits. Seventy-five study participants were assigned to the cohorts (25 per cohort). MMQS scores increased with increasing MGD severity, reflecting the selection criteria for the cohorts. Between-visit scores showed a weighted kappa statistic of 0.72 indicating substantial agreement. Mean scores of all assessed symptoms increased with increasing MGD severity. Scores for symptoms showed moderate (κ = 0.41-0.60) to substantial (κ = 0.61-0.80) agreement between visits. Overall ocular discomfort demonstrated the strongest correlation with the MMQS. The MMQS was a reproducible sign of MGD showing good agreement with ocular symptoms. Overall ocular discomfort was well correlated with typical dry eye symptoms and could potentially be used as a single measure of MGD symptoms. The findings from this observational study may inform endpoints for future clinical trials. ClinicalTrials.gov NCT01979887.
干眼症归因于泪液产生受损和/或蒸发性干眼症。蒸发性干眼症常与睑板腺功能障碍（MGD）有关。本研究的目的是确定与 MGD 相关的临床研究终点。这是一项为期 22 天的非干预性、病例对照临床研究，涉及三个队列，MGD 严重程度递增：无 MGD、轻度/中度 MGD 和重度 MGD。使用眼部症状问卷评估症状，对视力模糊、眼睛灼热、眼睛干燥、眼睛疼痛、畏光、眼睛瘙痒、眼睛异物感和整体眼部不适进行分级。体征评估包括最大睑脂质量评分（MMQS）、泪膜破裂时间、泪液分泌试验、生物显微镜检查和角膜染色。在队列和研究访问之间比较体征和症状。75 名研究参与者被分配到队列（每个队列 25 名）。MMQS 评分随 MGD 严重程度的增加而增加，反映了队列的选择标准。随访间评分的加权 Kappa 统计量为 0.72，表明存在实质性一致性。随着 MGD 严重程度的增加，所有评估症状的平均评分均增加。症状评分在随访之间显示出中度（κ=0.41-0.60）到高度（κ=0.61-0.80）一致性。整体眼部不适与 MMQS 相关性最强。MMQS 是 MGD 的一种可重复的体征，与眼部症状具有良好的一致性。整体眼部不适与典型的干眼症状相关性良好，可能可作为 MGD 症状的单一测量指标。这项观察性研究的结果可能为未来的临床试验终点提供信息。ClinicalTrials.gov NCT01979887。
