UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019017
Receipt number R000021996
Scientific Title Efficacy of Rho-kinase inhibitor ophthalmic solution on bleb formation after trabeculectomy, a randomized parallel study
Date of disclosure of the study information 2015/09/24
Last modified on 2023/02/01 19:06:17

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Basic information

Public title

Efficacy of Rho-kinase inhibitor ophthalmic solution on bleb formation after trabeculectomy, a randomized parallel study

Acronym

Efficacy of Rho-kinase inhibitor ophthalmic solution after trabeculectomy

Scientific Title

Efficacy of Rho-kinase inhibitor ophthalmic solution on bleb formation after trabeculectomy, a randomized parallel study

Scientific Title:Acronym

Efficacy of Rho-kinase inhibitor ophthalmic solution after trabeculectomy

Region

Japan


Condition

Condition

Open angle glaucoma

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of Rho-kinase inhibitor ophthalmic solution after trabeculectomy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Transition of intraocular pressure for twelve months after surgery
Bleb scoring at six months after surgery

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

0.4% ripasudil ophthalmic solution
Twice daily
For three months

Interventions/Control_2

No use of 0.4% ripasudil ophthalmic solution

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 who have trabeculectomy as the therapy of open angle glaucoma which is not sufficiently controlled.

Key exclusion criteria

1) Patients who had intraocular surgeries within six months.
2) Patients whose intraocular pressure are not able to be measured by Goldmann applanation tonometer.
3) Patients who had conjunctival surgeries (including glaucoma surgeries).
4) Patients who have an allergy to the ingredients of Rho-kinase inhibitor ophthalmic solution.
5) Patients who used Rho-kinase inhibitor ophthalmic solution before surgery.
6) Patients under the pregnancy or nursing.
7) Patients who are determined as an unsuitable person for this study by the doctor.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Yoshiaki
Middle name
Last name Kiuchi

Organization

Hiroshima University Hospital

Division name

Department of Ophthalmology

Zip code

7348551

Address

1-2-3, Kasumi, Minamiku, Hiroshima

TEL

082-257-5247

Email

ykiuchi@hiroshima-u.ac.jp


Public contact

Name of contact person

1st name Hideaki
Middle name
Last name Okumichi

Organization

Hiroshima University Hospital

Division name

Department of Ophthalmology

Zip code

7348551

Address

1-2-3, Kasumi, Minamiku, Hiroshima

TEL

082-257-5247

Homepage URL


Email

okumic@hiroshima-u.ac.jp


Sponsor or person

Institute

Department of Ophthalmology, Hiroshima University Hospital

Institute

Department

Personal name



Funding Source

Organization

Department of Ophthalmology, Hiroshima University Graduate School of Biomedical & Health Sciences

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethical Committee for Clinical Research of Hiroshima University

Address

1-2-3, Kasumi, Minamiku, Hiroshima

Tel

082-257-5907

Email

gaku-hiroshimajimu@office.hiroshima-u.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

広島大学病院(広島県),香川大学病院(香川県),白井病院(香川県),松江赤十字病院(島根県),ツカザキ病院(兵庫県),島根大学医学部附属病院(島根県)


Other administrative information

Date of disclosure of the study information

2015 Year 09 Month 24 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

122

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

2015 Year 09 Month 09 Day

Date of IRB

2015 Year 09 Month 14 Day

Anticipated trial start date

2015 Year 11 Month 01 Day

Last follow-up date

2022 Year 09 Month 30 Day

Date of closure to data entry

2022 Year 12 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 09 Month 14 Day

Last modified on

2023 Year 02 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021996


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name