UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016976 |
|---|---|
| Receipt number | R000019703 |
| Scientific Title | Exploratory clinical research of tacrolimus 0.1% solution for the bleb maintaining effects after trabeculectomy |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2021/10/04 23:42:13 |
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Basic information
Public title
Exploratory clinical research of tacrolimus 0.1% solution for the bleb maintaining effects after trabeculectomy
Acronym
Bleb maintaining effects of tacrolimus 0.1% solution after trabeculectomy
Scientific Title
Exploratory clinical research of tacrolimus 0.1% solution for the bleb maintaining effects after trabeculectomy
Scientific Title:Acronym
Bleb maintaining effects of tacrolimus 0.1% solution after trabeculectomy
Region
| Japan |
Condition
Condition
Primary open angle glaucoma, Normal tension glaucoma, Pseudo-exfoliation glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effectiveness of tacrolimus 0.1% solution to maintain the filtering bleb after trabeculectomy with inactive placebo.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Intraocular pressure difference between each group
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Target drug: tacrolimus 0.1% solution
Interventions/Control_2
control: artificial tear (My Tear eye drop)
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
a) Patients with POAG, or NTG, or PE glaucoma
b) Patients who was performed trabeculectomy to control the IOP
Key exclusion criteria
a) patients with the active ophthalmic disease except glaucoma
b) patients with retinal disease which may progress during the study period
c) patients with allergic history against tacrolimus
d) patients with the history of cataract surgery within one year
e) patients with the history of corneal refractive surgery
f) patients with the conjunctival scarring at the lesion of filtering bleb
g) patients with the post-ope IOP less than 5 mmHg
h) patients who was considered unsuitable by doctor in charge
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Mori |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Ophthalmology
Zip code
602-0841
Address
Kawaramachi Hirokouji, Kamigyoku, Kyoto 602-0841, JAPAN
TEL
075-251-5578
kmori@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Mori |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Ophthalmology
Zip code
602-0841
Address
Kawaramachi Hirokouji, Kamigyoku, Kyoto 602-0841, JAPAN
TEL
075-251-5575
Homepage URL
kmori@koto.kpu-m.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Senju Pharmaceutical Co.
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
KPUM IRB
Address
Kawaramachi Hirokouji, Kamigyoku, Kyoto
Tel
075-251-5578
n-aya@koto.kpu-m.ac.jp
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
| 2015 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
n/a
Publication of results
Unpublished
Result
URL related to results and publications
n/a
Number of participants that the trial has enrolled
60
Results
No statistically significant difference.
Results date posted
| 2021 | Year | 10 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Equally grouped
Participant flow
After dividing to the two group, IOP and bleb morphology were compared.
Adverse events
No significant differences.
Outcome measures
No significant IOP difference at 24 weeks.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 08 | Month | 21 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 30 | Day |
Last modified on
| 2021 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019703
| 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 |
