臨床研究等提出・公開システム

Japanese

Date of registration	Dec. 07, 2020
Last modified on	Nov. 19, 2023
Trial ID	jRCT2021200029

Scientific Title	A0003 Eye Drops 0.55% Phase III Study in Cystinosis Patients
Public Title	A0003 Eye Drops 0.55% Japan Phase III Study

Contact for Scientific Queries	Name	Ito Shuichi
	Affiliation	Yokohama City University Graduate School of Medicine
	Address	3-9, Fukuura, Kanazawa-ku, Yokohama city, Kanagawa, Japan 236-0004
	Telephone	+81-45-787-2669
	E-mail	itoshu@yokohama-cu.ac.jp
Contact for Public Queries	Name	Sugihara Yoko
	Affiliation	Viatris Inc.
	Address	Holland Hills Mori Tower, 5-11-2, Toranomon, Minato-ku, Tokyo, Japan 105-0001
	Telephone	+81-3-5733-9862
	E-mail	yoko.sugihara@viatris.com

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Dec. 01, 2020
Actual date of first enrollment
Target sample size		14
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Considered by the investigator or the sub-investigator being eligible for study participation, based on the results of screening tests conducted within 8 weeks before administration of A0003 Eye Drops 0.55% Whose leukocyte cystine concentration measured before initiation of Cysteamine treatment was > 1 nmol/1/2 cystine/mg protein or who was diagnosed with cystinosis Cystine crystal deposits in whose cornea was detected by slit lamp examination conducted at screening tests Has ability to or intend to comply with the 4 times daily instillation regimen
	Exclusion Criteria	Patients who have used Cysteamine eye drops within 1 year before administration of A0003 Eye Drops 0.55% Patients with uncontrolled hepatic disorder, cardiovascular disease, neurologic disease, or a cancer complication Patients with a history of hypersensitivity to Cysteamine, benzalkonium chloride, disodium edetate, carmellose sodium, citric acid monohydrate, or penicillamine
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Cystinosis
Intervention(s)		Administration of A0003 Eye Drops 0.55% 4 times day
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		IVCM Total Score by in vivo confocal microscopy
Secondary Outcome(s)		Luminance waveform analysis (LWA) by AS-OCT Photophobia rated by investigators Photophobia rated by patients

Primary Sponsor	Mylan EPD G.K.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	All Tohoku Clinical Trial Review and Audit Organization
Address	1-1, Seiryomachi, Aoba-ku, Sendai city, Miyagi
Telephone	+81-22-346-0325
E-Mail	office@activato.org
Approval Status	Approval
Date of approval	Jan. 06, 2020

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Nov. 19, 2023	(this page)	Changes
1	Dec. 07, 2020	Detail

List of change history