UMIN-CTR Clinical Trial

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
Scientific Title:Acronym
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
Last 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
1st 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
Institute	Senju Pharmaceutical co.,ltd.
Institute
Department

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
Oucome 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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029746