UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027512 |
|---|---|
| Receipt number | R000031534 |
| Scientific Title | The prospective research of the effect of topical ripasudil for pterigyum |
| Date of disclosure of the study information | 2017/05/29 |
| Last modified on | 2019/02/20 11:40:43 |
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Basic information
Public title
The prospective research of the effect of topical ripasudil for pterigyum
Acronym
The effect of topical ripasudil for pterygium
Scientific Title
The prospective research of the effect of topical ripasudil for pterigyum
Scientific Title:Acronym
The effect of topical ripasudil for pterygium
Region
| Japan |
Condition
Condition
Pterygium
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of topical ripasudil for pterygium prospectively.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We capture the image of anterior segment of eyes and evaluate the time-dependent change of the area of pterygium.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
0.4% ripasudil is instilled for treatment group twice a day (morning and evening). Instillation is continued for six months.
Interventions/Control_2
No treatment.
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) Pterygium does not regress spontaneously during observation period for two months.
2) The edge of pterygium is smaller than two thirds of corneal radius.
3) A person is more than 20 years old.
4) The consent of the document is obtained.
Key exclusion criteria
1) Persons who are contraindicated for the test drugs.
2) Persons who are allergic to ripasudil.
3) Persons who had severe corneal, conjunctival and intraocular disease.
4) Persons who are thought as inappropriate by principal or subprincipal doctors.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Miyata Kazunori |
Organization
Miyata Eye Hospital
Division name
Ophthalmology
Zip code
Address
6-3 Kurahara, Miyakonojyo, Miyazaki, 885-0051, Japan
TEL
0986-22-1441
miyata@miyata-med.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ono Takashi |
Organization
Miyata Eye Hospital
Division name
Ophthalmology
Zip code
Address
6-3 Kurahara, Miyakonojyo, Miyazaki, 885-0051, Japan
TEL
0986-22-1441
Homepage URL
ono@miyata-med.ne.jp
Sponsor or person
Institute
Miyata Eye Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
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
| 2017 | Year | 05 | Month | 29 | 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
| 2016 | Year | 10 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 28 | Day |
Last modified on
| 2019 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031534
