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

Yamada Hiroyuki0 sites50 target enrollmentJune 28, 2021

Overview

No summary available.

Registry

who.int

Start Date

June 28, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Observational

Sex

All

Sponsor

Yamada Hiroyuki

•Written informed consent must be obtained before any assessment is performed.
•\- Male or female participants 18 years of age or older:
•a. For healthy volunteers no history, signs or symptoms of dry eye disease or any ocular surface disease, no current or recent (within 6 months) chronic or recurrent eye drop use and a Meibomian Gland Secretion Score of \>\=40 at screening visit in both eyes.
•b. For MGD patients must have a present diagnosis of mild, moderate, or severe MGD at screeningvisit of at least one eye.
•\- Able to communicate well with the investigator, to understand and comply with the requirements of the study.

•\- Use of investigational drugs within 30 days (e.g. small molecule) or 5 half lives of screening or until the expected pharmacodynamic effect has returned to baseline (e.g. biologics), whichever is longer; or longer if required by local regulations or anticipated participation in clinical trials involving treatment during the course of the study.
•\- Any active or recurrent infection or ocular disease involving ocular surface or ocular adnexa including infectious conjunctivitis, keratitis, scleritis, herpetic eye disease, as well as idiopathic or auto\-immune\-associated uveitis in either eye.
•\- Treatment with MGD devices (e.g., LipiFlow or other similar devices delivering heat/massage to the lids, Intense Pulse Light Therapy, Meibomian gland duct probing) within 6 months prior to Screening.
•\- Treatment with antimicrobials (e.g., doxycycline or other tetracycline derivatives, azithromycin), or steroids within 30 days prior to Screening.
•\- Presence of ocular or non\-ocular conditions or circumstances that could interfere with the participant ability to participate in the full duration of the trial or complete study visits as indicated in the protocol.
•\- Monocular participants (i.e., participants who have had enucleation of one eye)