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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name