UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029669 |
|---|---|
| Receipt number | R000033904 |
| Scientific Title | The prospective exploratory study of safety and efficacy on the patients post-penetrating keratoplasty of topical tacrolimus 0.1%. |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2022/10/28 15:21:43 |
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Basic information
Public title
The prospective exploratory study of safety and efficacy on the patients post-penetrating keratoplasty of topical tacrolimus 0.1%.
Acronym
Inhibitory effect of topical tacrolimus 0.1% on the rejection of corneal graft.
Scientific Title
The prospective exploratory study of safety and efficacy on the patients post-penetrating keratoplasty of topical tacrolimus 0.1%.
Scientific Title:Acronym
Inhibitory effect of topical tacrolimus 0.1% on the rejection of corneal graft.
Region
| Japan |
Condition
Condition
Penetrating keratoplasty (PKP)
Classification by specialty
| Ophthalmology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This prospective study aims to evaluate the safety and efficacy of topical tacrolimus 0.1% on the patients post-PKP.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Rejection rates of the graft on week 52 post-operatively.
Key secondary outcomes
1) Survival rates of the graft on week 52 post-operatively
"2) Survival rates of the graft on week 26, 52 and last observation post-operatively
3) Adverse drug reactions on week 26, 52 and last observation post-operatively
4) Best corrected visual acuity
5) Corneal endthelial cell density
6) Influenced factors to survival rate of the graft on week 52 post-operatively
7) Survival rates of the graft when adjustment of influence factors
8) Recruitment of dendritic cell and reconstitution of trigerminal"
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Target drug: tacrolimus 0.1% ophthalmic susupension
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
"Patients with PKP who are relevant the following conditions
1) Patients with the history of PKP
2) Patients with the history of rejection
3) Patients with vascuralization in corneal stroma (more than half)
4) Atopic patients with karatoconus "
Key exclusion criteria
1) Patients with allergic history against tavrolimus ophthalmic susupension
2) Patients with infectious eye disease
3) Patients with allergic history against betamethasone or fluorometholone ey drop
4) Diabetic patients with poor glycemic control
5) Glaucoma patients with poor IOP control
6) Patients with severe infectious disease
7) Patients with limbal transplantation
8) Patients with cancer, severe liver dysfunction, severe renal dysfunction, severe cardiac disease, and other severe conditions
9) Pregnant women, lactating women, may possibly be pregnant women
10) Patients whom the prior treatment with topical or systemic use of steroid or immunosuppressant within 4 week before initiation
11) Patients whom are expected to need a contraindicated durg use or therapy in the study period
12) Patients whom are considered unsuitable by doctor in charge
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Shimazaki |
Organization
Tokyo Dental Collage Ichikawa General Hospital
Division name
Ophthalmology
Zip code
2728513
Address
5-11-13 Sugano, Ichikawa, Chiba
TEL
0473220151
jun@eyebank.or.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Shimazaki |
Organization
Tokyo Dental Collage Ichikawa General Hospital
Division name
Ophthalmology
Zip code
2728513
Address
5-11-13 Sugano, Ichikawa, Chiba
TEL
0473220151
Homepage URL
jun@eyebank.or.jp
Sponsor or person
Institute
Tokyo Dental Collage Ichikawa General Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Dental Collage Ichikawa General Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Senju Pharmaceutical Co., Ltd
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Certified Review Board of Keio
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-5363-3503
med-nintei-jimu@adst.keio.ac.j
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 | 11 | Month | 01 | 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
| 2017 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 23 | Day |
Last modified on
| 2022 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033904
