UMIN-CTR Clinical Trial

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
Institute	Tokyo Dental Collage Ichikawa General Hospital
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033904