meibomian gland dysfunction
Conditions
Interventions
None listed
Sponsors
Yamada Hiroyuki
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical characteristics and disease progression | — |
Countries
Japan, Thai, UK, US
Contacts
Public ContactHiroyuki Yamada
Novartis Pharma. K.K.
Outcome results
None listed