Impact of the 2011 International Workshop on Meibomian Gland Dysfunction on clinical trial attributes for meibomian gland dysfunction

Abstract

Purpose: The 2011 International Workshop on Meibomian Gland Dysfunction was organized to build consensus on various disease aspects of MGD. The purpose of this review was to examine the influence of the MGD Workshop on clinical trials by examining their attributes prior to and after the Workshop.

Methods: A search for clinical trials using the terms "Meibomian Gland Dysfunction" was conducted using the "Interventional Studies" filter on ClinicalTrials.gov, and selecting studies with posting and start dates prior to (2004-2010) and after the Workshop (2012-2018). The inclusion criteria, outcome measures, and study designs and rigor were examined.

Results: A total of 32 post-Workshop and 5 pre-Workshop clinical trials were identified with the search. The proportion of pre-Workshop trials using generic diagnosis and systematic assessments to define MGD was similar to that of post-Workshop trials. In both pre- and post-Workshop trials, symptoms, altered gland secretions, and alteration in tear film were the most frequent clinical attributes used to define MGD. The most frequent outcome measures used for pre-Workshop and post-Workshop trials were also similar: symptoms, meibum quality/expressibility, and tear stability.

Conclusions: The nature of the inclusion criteria, and the clinical attributes used to define MGD during the pre-Workshop period were similar to those of the post-Workshop period, suggesting that the MGD Workshop has had a minimal impact on the design of interventional trials for MGD.

Keywords: Clinical trials; Criteria; Definition classification; Meibomian gland dysfunction.