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

Not Applicable

• Conditions: meibomian gland dysfunction

• Registration Number: JPRN-jRCT1030210166
• Lead Sponsor: Yamada Hiroyuki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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.

Exclusion Criteria

- 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)

Study & Design

• Study Type: Observational
• Study Design: Not specified