臨床研究等提出・公開システム

Date of registration	Oct. 24, 2022
Last modified on	Aug. 30, 2024
Trial ID	jRCT2031220407

Scientific Title	KRP-KC121E Phase 2 -A Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Study in Patients with Meibomian Gland Dysfunction
Public Title	Placebo-Controlled, Parallel-Group Study of KRP-KC121E in Patients with Meibomian Gland Dysfunction

Completion date	June. 26, 2023
Result actual enrolment	65
Baseline Characteristics	[sex] Male: 19 participants (29.2%), Female: 46 participants (70.8%) [a mean of age] 48.4 years
Participant flow	[Informed Consent] 86 participants [Randomized] 65 participants [Completed] 63 participants
Adverse events	There were no deaths or serious adverse events.
Outcome measures	Efficacy: There was no statistical significant difference in improvement in inflammatory findings between KRP-KC121E and placebo group. Safety: Described in "Adverse events" section.
Brief summary	There was no statistical significant difference in the primary endpoint between KRP-KC121E and placebo group.
Date of posting of results summaries	Aug. 30, 2024

Plan to share IPD	No
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCT2031220407

Contact for Scientific Queries	Name	Omatsu Kazunori
	Affiliation	Senju Pharmaceutical Co., Ltd.
	Address	6-4-3, Minatojima-Minamimachi, Chuo-ku, Kobe, Hyogo
	Telephone	+81-78-777-1018
	E-mail	senju-clinicaltrials@senju.co.jp
Contact for Public Queries	Name	Clinical development division
	Affiliation	Senju Pharmaceutical Co., Ltd.
	Address	6-4-3, Minatojima-Minamimachi, Chuo-ku, Kobe, Hyogo
	Telephone	+81-78-777-1018
	E-mail	senju-clinicaltrials@senju.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Oct. 25, 2022
Actual date of first enrollment		Nov. 10, 2022
Target sample size		60
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	-Aged over 18 years at the time of Informed Consent(any gender) -Live in Japan -Have Meibomian Gland Dysfunction in both eyes -Meet the other protocol-specified inclusion criteria
	Exclusion Criteria	-Unable to discontinue wearring contact lens during the study -Have history of, or scheduled ocular surgery during the study -Have active ocular disease -Have severe systemic illness -Known history of hypersensitivity to any of the drugs used in the study -Patient who is pregnant, lactating, potentially pregnant -Have judged that it is inappropriate to participate in this study by investigator -Meet the other protocol-specified exclusion criteria
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Meibomian Gland Dysfunction
Intervention(s)		Eye instillation of KRP-KC121E or placebo to patients with Meibomian Gland Dysfunction
Primary Outcome(s)		Improvement in inflammation, adverse events etc.
Secondary Outcome(s)		Improvement in inflammation

Primary Sponsor	Senju Pharmaceutical Co., Ltd.

Secondary Sponsor

Name of Certified Review Board	Medical Corporation Cattleyakai Dr.Mano Medical Clinic IRB
Address	1-8-1 Ebisu, Shibuya-ku, Tokyo, Tokyo
Telephone	+81-3-6779-8166
E-Mail	chi-pr-cirb-mano@cmicgroup.com
Approval Status	Approval
Date of approval	Oct. 13, 2022

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
6	Aug. 30, 2024	(this page)	Changes
5	Sept. 09, 2023	Detail	Changes
4	Mar. 25, 2023	Detail	Changes
3	Dec. 13, 2022	Detail	Changes
2	Nov. 25, 2022	Detail	Changes
1	Oct. 24, 2022	Detail

List of change history