UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026471
Receipt number R000029746
Scientific Title Phase III long-term safety study of SJP-0135 in patients with primary open-angle glaucoma or ocular hypertension
Date of disclosure of the study information 2017/03/09
Last modified on 2019/03/11 12:06:37

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Basic information

Public title

Phase III long-term safety study of SJP-0135 in patients with primary open-angle glaucoma or ocular hypertension

Acronym

A long-term safety study of SJP-0135 in patients with primary open-angle glaucoma or ocular hypertension

Scientific Title

Phase III long-term safety study of SJP-0135 in patients with primary open-angle glaucoma or ocular hypertension

Scientific Title:Acronym

A long-term safety study of SJP-0135 in patients with primary open-angle glaucoma or ocular hypertension

Region

Japan


Condition

Condition

Primary open-angle glaucoma (broad definition) or ocular hypertension

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the safety and efficacy (IOP reduction) of twice-daily dosed SJP-0135 ophthalmic solution for 52 weeks in patients with primary open-angle glaucoma (broad definition) or ocular hypertension

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Safety: Adverse events, ophthalmologic examination, blood pressure, pulse rate, laboratory test
Efficacy: Changes from the baseline in intraocular pressure (IOP) at each visit (Hour 2)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

One drop of SJP-0135 ophthalmic solution is instilled into each eye twice-daily (in the morning and in the evening) for 52 weeks.

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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Written informed consent obtained after adequate explanation on participating the study
2) Japanese male or female outpatient, 20 years of age or older
3) Patients with primary open-angle glaucoma (broad definition) or ocular hypertension in both eyes

Key exclusion criteria

1) History of surgical intervention or laser treatment for glaucoma
2) History of intraocular surgery
3) Presence of any circulatory failure such as cerebrovascular disease, orthostatic hypotension, cardiovascular disease and not eligible in the opinion of the investigator or the sub-investigator
4) Presence or history of bronchial asthma, bronchospasm or serious chronic obstructive pulmonary disease
5) Presence or history of uncontrolled heart failure, sinus bradycardia, atrioventricular block (Grade II or III) or cardiogenic shock
6) Presence of right heart failure caused by pulmonary hypertension, congestive heart failure, diabetic ketoacidosis, metabolic acidosis or uncontrolled diabetes mellitus
7) Serious visual field defect
8) History of corneal transplantation or keratorefractive surgery

Target sample size

125


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Makoto Araie

Organization

Kanto Central Hospital

Division name

-

Zip code


Address

6-25-1, Kamiyoga, Setagaya-ku, Tokyo, 158-8531 Japan

TEL

03-3429-1171

Email

araie-tky@umin.net


Public contact

Name of contact person

1st name
Middle name
Last name Takuro Sekiya

Organization

Senju Pharmaceutical co.,ltd.

Division name

Clinical Development

Zip code


Address

2-5-8, Hirano-machi, Chuo-ku, Osaka, Japan

TEL

06-6201-9630

Homepage URL


Email

t-sekiya@senju.co.jp


Sponsor or person

Institute

Senju Pharmaceutical co.,ltd.

Institute

Department

Personal name



Funding Source

Organization

Senju Pharmaceutical co.,ltd.

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


Address


Tel


Email



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 03 Month 09 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

2016 Year 12 Month 16 Day

Date of IRB

2017 Year 01 Month 26 Day

Anticipated trial start date

2017 Year 01 Month 30 Day

Last follow-up date

2018 Year 06 Month 07 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 03 Month 09 Day

Last modified on

2019 Year 03 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029746


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name