UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038182 |
|---|---|
| Receipt number | R000043524 |
| Scientific Title | Open study of SGP2 for myopia and myopic astigmatism |
| Date of disclosure of the study information | 2019/10/03 |
| Last modified on | 2020/09/25 15:31:24 |
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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
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
tojima@rohto.co.jp
Sponsor or person
Institute
ROHTO pharmaceutical CO.,LTD
Institute
Department
Personal name
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
-
-
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043524
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
