Abstract
Purpose :
Dry Eye Disease (DED) is characterized by two main types: aqueous deficiency and evaporative tear loss. Evaporative tear loss is frequently associated with Meibomian Gland Dysfunction (MGD). Given the importance of evaluating symptoms for regulatory approval, a clinical trial was performed to characterize MGD severity and identify clinical endpoints that can be potentially used for drug registrational purposes to treat MGD.
Methods :
This prospective, multicenter, non-interventional study enrolled three cohorts based on standardized criteria: subjects without MGD, mild-to-moderate MGD, and severe MGD. The Subject Ocular Symptom Questionnaire (SOSQ) assessed blurred vision, burning, dryness, pain, light sensitivity, itching, and foreign body sensation as well as overall ocular discomfort over the last 7 days. Patient responses were assessed on a 5-point severity scale from 0 (none) to 4 (very severe). Inter-item correlation analysis (arithmetic means) was calculated to provide a global estimate of symptom correlation of Overall Ocular Discomfort with the other 7 ocular symptoms representative of MGD. The repeatability of the Overall Ocular Discomfort item was examined using test-retest reliability methods and weighted Kappa (Κw) statistics with 95% confidence intervals (CI).
Results :
70 subjects were enrolled across 3 cohorts with a Tear Break Up Time (TBUT) <10 seconds. The correlation of Overall Ocular Discomfort with other ocular symptoms ranged from moderately strong to strong (0.684 to 0.844). Additionally, the average of the inter-item correlations suggests that Overall Ocular Discomfort demonstrated moderately strong global correlations with all 7 symptoms (r2=0.777). Overall Ocular Discomfort demonstrated acceptable reproducibility, with calculated Kw coefficients of 0.66.
Conclusions :
MGD and DED has a significant impact on ocular symptoms and vision related activities. The correlation of Overall Ocular Discomfort with other ocular symptoms was strong throughout the study. The findings from this observational study can help inform endpoints and PRO development for future clinical trials in patients with MGD and DED.
This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.