OBJECTIVES: A prospective, exploratory, non-treatment study was conducted to characterize the severity of signs and symptoms of Meibomian Gland Dysfunction (MGD). We report the results of the MGD Impact Questionnaire (MGD IQ), developed using FDA guidance and utilized to characterize the severity of disease impact on vision related activities.

METHODS: 75 patients were enrolled in three cohorts (NCT01979887): (i) non-MGD, (ii) mild to moderate MGD, and (iii) severe MGD. Assessments were performed at two visits (Day 1 and Day 22) to measure the degree of concordance in outcomes. The MGD IQ included 10 items on a Likert scale measuring the impact on activities including: work, outdoor activities, and time spent on eye care. Questions 1 – 7 were on a scale of 0 (“Not applicable/Did not work”) to 5 (“A lot of difficulty”). Questions 8 – 10 were on a scale of 0 (“Not at all bothered”) to 4 (“Very bothered”). Pairwise comparisons between levels of MGD severity were performed using the Cochran Mantel-Haenszel method, and the weighted Kappa statistics was used for agreement.

RESULTS: Incremental increases in scores were observed with increasing MGD severity at both visits with 8/10 questions in the MGD IQ. Comparisons of responses showed significantly higher scores (p = <0.001 to 0.044) at Days 1 and 22 for 4 questions between the severe and non-MGD cohorts. Additionally, responses showed significantly higher scores (p = 0.005 to 0.045) at Day 1 for the severe MGD cohort compared to the mild/moderate MGD cohort for 5 questions. Agreement between visits for MGD IQ responses ranged from 0.33 to 0.58, indicating fair to moderate agreement.

CONCLUSIONS: The MGD IQ demonstrated that patients are impacted by vision related activities, which increased with severity. This novel MGD IQ instrument can help characterize severity and amplify the patient’s voice on burden of disease.