Evaluating the clinical characteristics and disease progression of MGD

• Research type

  Research Study

• Full title

  A prospective study to evaluate the clinical characteristics and disease progression of participants with meibomian gland dysfunction (MGD)

• IRAS ID

  290283

• Contact name

  James Wolffsohn

• Contact email

  j.s.w.wolffsohn@aston.ac.uk

• Sponsor organisation

  Novartis Pharma AG

• Duration of Study in the UK

  5 years, 8 months, 1 days

• Research summary

  Summary of Research:
  This natural history study will better characterise the progression of participants with MGD(Meibomian gland dysfunction) through a longitudinal study of morphologic ocular imaging (meibography), evaluation of clinical disease severity, and ocular surface disease endpoints across a diverse ethnic population. This study will help in the selection of the appropriate population for future studies, appropriate endpoints, and insights to potential future therapeutic interventions.

  Approximately 400 evaluable adults will be enrolled globally, including 300 adult patients with a confirmed diagnosis of MGD and 100 healthy volunteers in a comparison group. There will be 4 sites in the UK, with a target of 120 patients in total.

  The study will consist of an observational period of up to 5 years and include patients with MGD and a control population of “normal” healthy volunteers (participants with healthy ocular surface without signs and symptoms of MGD/Dry Eye). Participants will be stratified based on race
  and investigator determined disease severity.

  No specific treatments will be administered as part of this study. Investigators will treat participants as needed per their standard clinical practice and participants will be followed over time with no study specific action/requirement except for collection of all protocol assessments.

  Summary of Findings:
  A lay summary will not be published. Per Novartis SOPs, we commit to providing a plain language summary for studies with approved final protocol synopsis from 01 Sep 2018.

• REC name

  Wales REC 6

• REC reference

  21/WA/0053

• Date of REC Opinion

  29 Mar 2021

• REC opinion

  Further Information Favourable Opinion