臨床研究等提出・公開システム

Japanese

Date of registration	June. 28, 2021
Last modified on	Oct. 20, 2022
Trial ID	jRCT1030210166

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

Contact for Scientific Queries	Name	Yamada Hiroyuki
	Affiliation	Novartis Pharma. K.K.
	Address	Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan
	Telephone	+81-120-003-293
	E-mail	rinshoshiken.toroku@novartis.com
Contact for Public Queries	Name	Yamada Hiroyuki
	Affiliation	Novartis Pharma. K.K.
	Address	Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan
	Telephone	+81-120-003-293
	E-mail	rinshoshiken.toroku@novartis.com

Recruitment status	Not Recruiting

Anticipated date of first enrollment		June. 17, 2021
Actual date of first enrollment		July. 06, 2021
Target sample size		50
Study Type		Observational
Study Design	allocation
	masking
	control
	assignment
	purpose
Key inclusion & exclusion 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	- 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)
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		meibomian gland dysfunction
Intervention(s)		-
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		clinical characteristics and disease progression
Secondary Outcome(s)

Primary Sponsor	Novartis Pharma. K.K.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Adachikyousai Hospital Institutional Review Board
Address	1-36-8, Yanagihara, Adachi-ku, 120-0022, Japan, Tokyo
Telephone	+81-3-3881-6116
E-Mail	c-irb_ug@neues.co.jp
Approval Status	Approval
Date of approval	Jan. 21, 2021

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	US/UK/Thai

History of Changes

No	Publication date
3	Oct. 20, 2022	(this page)	Changes
2	July. 09, 2021	Detail	Changes
1	June. 28, 2021	Detail

List of change history