UMIN-CTR Clinical Trial

Basic information
Public title	Open study of SGP2 for myopia and myopic astigmatism
Acronym	Open study of SGP2 for myopia and myopic astigmatism
Scientific Title	Open study of SGP2 for myopia and myopic astigmatism
Scientific Title:Acronym	Open study of SGP2 for myopia and myopic astigmatism
Region	Japan

Condition
Condition	Myopia and myopic astigmatism
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the safety and efficacy of SGP2 when is used for those with myopia or myopic astigmatic eyes that require vision correction.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety(13 weeks after first day the subect used)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Over 13weeks
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) =>20 years of age on the day of signing the informed consent. (2) Patient who understands the gist of the clinical trial and who has signed the Informed Consent Form with his / her free will (3) Patient with myopic or myopic astigmatic eyes that require vision correction in both eyes
Key exclusion criteria	(1) Patient who have the following eye symptoms in one or both eyes. - Acute or subacute inflammation of the anterior segment - Eye infection - Uveitis - Eyelid abnormalities
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Hideki Middle name Last name Tojima
Organization	ROHTO pharmaceutical CO.,LTD
Division name	Clinical Development Division
Zip code	619-0216
Address	6-5-4Kunimidai, Kizugawa, Kyoto, Japan
TEL	0774-71-8820
Email	tojima@rohto.co.jp

Public contact
Name of contact person	1st name Hideki Middle name Last name Tojima
Organization	ROHTO pharmaceutical CO.,LTD
Division name	Clinical Development Division
Zip code	619-0216
Address	6-5-4Kunimidai, Kizugawa, Kyoto, Japan
TEL	0774-71-8820
Homepage URL
Email	tojima@rohto.co.jp

Sponsor
Institute	ROHTO pharmaceutical CO.,LTD
Institute
Department

Funding Source
Organization	ROHTO pharmaceutical CO.,LTD
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Goshodukashinryosyo IRB
Address	1-21-4Goshoduka, Miyamaeku, Kawasaki-shi, Kanazawa, Japan
Tel	-
Email	-

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 10 Month 03 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 09 Month 26 Day
Date of IRB	2019 Year 10 Month 18 Day
Anticipated trial start date	2019 Year 11 Month 01 Day
Last follow-up date	2020 Year 05 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 10 Month 02 Day
Last modified on	2020 Year 09 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043524