UMIN-CTR Clinical Trial

Public title

Efficacy and safety of ripasudil hydrochloride in glaucoma patients being treated by prostaglandin analogues, but their intraocular pressures are 15mmHg or under.

Acronym

Efficacy and safety of ripasudil hydrochloride in glaucoma patients being treated by prostaglandin analogues, but their intraocular pressures are 15mmHg or under.

Scientific Title

Efficacy and safety of ripasudil hydrochloride in glaucoma patients being treated by prostaglandin analogues, but their intraocular pressures are 15mmHg or under.

Scientific Title:Acronym

Efficacy and safety of ripasudil hydrochloride in glaucoma patients being treated by prostaglandin analogues, but their intraocular pressures are 15mmHg or under.

Region

Japan

Condition

glaucoma

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the efficacy and safety of ripasudil hydrochloride in glaucoma patients in case of insufficiently IOP control by prostaglandin-related drug monotherapy although their IOPs are 15mmHg or under.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Comparison of intraocular pressure between at baseline (week 0) and at follow-up period (week 12)

Key secondary outcomes

1. Change of intraocular pressure in the study eye at the same time of week 4 from baseline (week 0)
2. Achievement rate of -20% or -30% intraocular pressure reduction in the study eye at the same time of week 12 from baseline (week 0)
3. Difference of intraocular pressure reduction between the study eye and non-treated eye at the same time of week 12 from baseline (week 0)
4. Difference of intraocular pressure reduction between the study eye and non-treated eye at the same time of week 4 from baseline (week 0)
5. Change of indexes listed below at the study eye at the same time of week 12 from baseline (week 0)
6. Change of indexes listed below at the study eye at the same time of week 4 from baseline (week 0)
7. Differences of indexes listed below between the study eye and non-treated eye at the same time of week 12 from baseline (week 0)
8. Differences of indexes listed below between the study eye and non-treated eye at the same time of week 4 from baseline (week 0)
9. Change of difference between the study eye and non-treated eye from baseline to week 12
10. Frequency of adverse events and adverse reactions

<indexes>
intraocular pressure measured by Goldmann applanation tonometer
visual acuity
gonioscopy test
slit lamp microscope test
fundus test
history of prostaglandin-related drug treatment

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

75

years-old

>

Gender

Male and Female

Key inclusion criteria

Patients who meet all of the following criteria are included in this study.
1. One prostaglandin-related drug did not provide sufficient reduction in intraocular pressure, and after December 2017, at the discretion of the attending physician, additional glaucoma treatment with ripasudil hydrochloride was required or will be performed Glaucoma patients in the future.
2. Intraocular pressure of both eyes are 15mmHg or lower at their consent and week 0, and difference of intraocular pressure at their consent and at the latest consultation before the consent is 2mmHg or lower.
3. Male and female patients aged 20 years or older and younger than 75 years when giving their consent.
4. Patients who can give their consent in a written form

Key exclusion criteria

Patients who fall into any of the following criteria are excluded from participating in the study.
1. Patients with a contraindicated condition to use the study drug
2. Patients who are breastfeeding, pregnant, or parturient
3. Patients whose best-corrected visual acuity is less than 0.5
4. Patients whose spherical equivalent is less than -0.9D or +0.9 or higher
5. Patients in whom the difference of spherical equivalent between both eyes is 3D or higher
6. Patients whose intraocular pressure can not be correctly measured by Goldmann applanation tonometer
7. Patients whose mydriasis is insufficient and in whom the observation of the optic nerve head is impossible
8. Patients with history of invasive eye surgery or laser treatment, except cataract surgery within 6 months
9. Patients with eye trauma
10. Patients with complication of retina disease which affect visual field
11. Patients with optic nerve disease or intracranial disease which affect visual field
12. Patients with other conditions that the investigator/researcher thinks inappropriate for the study

Target sample size

30

Name of lead principal investigator

1st name	Shiroaki
Middle name
Last name	Shirato

Organization

Yotsuya Shirato Ophthalmology Clinic

Division name

Ophthalmology

Zip code

160-0004

Address

Yotsuya Mitsuke building 3F, 1-1, Yotsuya, Shinjyuku, Tokyo, Japan

TEL

03-3355-4281

Email

shirato-eye-clinic@vanilla.ocn.ne.jp

Name of contact person

1st name	Hiroki
Middle name
Last name	Takayama

Organization

Soiken Inc.

Division name

Clinical Study Support Division

Zip code

101-0052

Address

NBF Ogawamachi Building 4F, 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo

TEL

03-3295-1350

Homepage URL

Email

takayama@soiken.com

Institute

Yotsuya Shirato Ophthalmology Clinic

Institute

Department

Personal name

Organization

Kowa Company, Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Fukuda Internal Clinic IRB

Address

Shin-Osaka brick building 2F, 1-6- 1 Miyahara, Yodogawa-ku, Osaka-shi, Osaka

Tel

06-6398-0203

Email

fukudaclinicIRB@gmail.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

01

Month

18

Day

URL releasing protocol

unpublished

Publication of results

Published

URL related to results and publications

https://link.springer.com/article/10.1007/s12325-021-01775-x

Number of participants that the trial has enrolled

30

Results

The treated eyes showed significant reduction in IOP at 1 and 3 months. In contrast, contralateral untreated eyes did not show IOP reduction. IOP reduction of - 20% and - 30% was achieved in 30% and 10% treated eyes, respectively. There were significant differences in IOP between the treated and contralateral untreated eyes at 1 and 3 months. Two patients experienced local adverse events but soon recovered by discontinuing ripasudil. Ripasudil could be used to enhance the outcome of FP monotherapy.

Results date posted

2023

Year

07

Month

20

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Age (year): 59.4+/-12.5
Sex: male 10 (33.3%) / female 20 (66.7%)
Duration of glaucoma: 3.7+/-1.8

Participant flow

2019/1/21 First subject in
2020/1/21 Last subject in
2020/6/22 Last subject last visit

Adverse events

Death: 0 (0.0%)
Adverse Event: 2 (6.7%)
Serious Adverse Event: 0 (0.0%)

Outcome measures

Primary endpoint
Change in IOP in ripasudil-treated eyes from baseline to week 12

Secondary endpoints
1. Change in IOP in ripasudil-treated eyes from baseline to week 4
2. Proportion of ripasudil-treated eyes showing a 20% and 30% reduction in IOP at week 12
3. Difference in change in IOP between ripasudil-treated and non-ripasudil-treated eyes at week 12
4. Difference in change in IOP between ripasudil-treated and non-ripasudil-treated eyes at week 4
5. Change in other observation items in ripasudil-treated eyes from baseline to week 12
6. Change in other observation items in ripasudil-treated eyes from baseline to week 4
7. Difference in change in other observation items between ripasudil-treated and non-ripasudil-treated eyes at week 12
8. Difference in change in other observation items between ripasudil-treated and non-ripasudil-treated eyes at week 4
9. Change in difference of observation items between ripasudil-treated and non-ripasudil-treated eyes from baseline to week 12
10. Frequency of adverse event and side effect

Plan to share IPD

none

IPD sharing Plan description

none

Recruitment status

Completed

Date of protocol fixation

2017

Year

12

Month

21

Day

Date of IRB

2018

Year

10

Month

20

Day

Anticipated trial start date

2019

Year

01

Month

18

Day

Last follow-up date

2020

Year

04

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

none

Registered date

2018

Year

01

Month

10

Day

Last modified on

2023

Year

07

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035103