UMIN-CTR Clinical Trial

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
Email	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
Email	kmori@koto.kpu-m.ac.jp

Sponsor
Institute	Department of Ophthalmology, Kyoto Prefectural University of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019703