195263-007 Meibomian Gland Dysfunction
Research type
Research Study
Full title
Exploratory Sign and Symptom Characterization of Subjects With and Without Meibomian Gland Dysfunction
IRAS ID
139767
Contact name
Michel Guillon
Contact email
Sponsor organisation
Allergan
ISRCTN Number
ISRCTN
Research summary
The purpose of this study is to characterise subject populations with and without Meibomian Gland Dysfucntion (MGD) by systematically evaluating a number of standard and non standard eye procedures.
This will help identify which is the best single, or combination of endpoints to identify MGD in patients. This study does not involve any drug, and will be conducted in the US and EU.
Male or female patients, of 40 years of age or older and who meet the eligibility criteria, will be invited to participate. Subjects will be enrolled in three cohorts, consisting of approximately 25 patients. Patients will be assigned to each of the three cohorts depending on the severity of MGD (no MGD, mild to moderate MGD, and severe MGD).
Approximately 160 patients will be screened to populate each cohort for a total of approximately 75 patients. The study duration is approximately 8 weeks per patient and comprises of up to 3 scheduled visits.REC name
London - Stanmore Research Ethics Committee
REC reference
13/LO/1634
Date of REC Opinion
10 Dec 2013
REC opinion
Further Information Favourable Opinion