UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase III comparative study to evaluate the efficacy and safety of SJP-0125 versus brinzolamide in patients with primary open-angle glaucoma or ocular hypertension
Title of the study (Brief title)	A comparative study to evaluate the efficacy and safety of SJP-0125 versus brinzolamide 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 evaluate the efficacy (intraocular pressure reduction) and safety of twice-daily dosed SJP-0125 for 4 weeks compared to 1% brinzolamide ophthalmic solution in patients with primary open-angle glaucoma (broad definition) or ocular hypertension and to confirm if SJP-0125 and concurrent administration of 0.1% brimonidine tartrate and 1% brinzolamide ophthalmic solution as a reference arm have the same efficacy and safety profile.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in IOP (hour 2) from the start day of the treatment period at Week 4
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	One drop of 1% brinzolamide ophthalmic solution is instilled into each eye twice-daily (in the morning and in the evening) for 4 weeks, and then one drop of SJP-0125 is instilled into each eye twice-daily (in the morning and in the evening) for 4 weeks.
Interventions/Control_2	One drop of 1% brinzolamide ophthalmic solution is instilled into each eye twice-daily (in the morning and in the evening) for 4 weeks, and then one drop of 0.1% brimonidine tartrate is instilled into each eye twice-daily (in the morning and in the evening) for 4 weeks.
Interventions/Control_3	One drop of 1% brinzolamide ophthalmic solution is instilled into each eye twice-daily (in the morning and in the evening) for 4 weeks, and then one drop of 0.1% brimonidine tartrate is instilled into each eye twice-daily (in the morning and in the evening) for 4 weeks.
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 4) Required ophthalmic solution for IOP-lowering treatment 5) IOP =< 31.0 mmHg 6) Best corrected visual acuity >= 0.3
Key exclusion criteria	1) Prior ocular instillation of SJP-0125 2) History of surgical intervention or laser treatment for glaucoma 3) History of intraocular surgery within past 90 days 4) Anticipated wearing of any contact lenses 5) Intraocular injection, sub-Tenon or subconjunctival injection of a corticosteroid agent within past 180 days 6) Patients who are pregnant, breastfeeding, or potentially pregnant. or who desire to be pregnant or who do not intend to prevent conception from consent to the end of the treatment period 7) Participated in any other clinical trial within past 90 days and received any other investigational drug or plans to participate in any other clinical trial during the study 8) Presence of any active retinal disease which may progress during the study 9) Presence of any active ocular disease other than primary open-angle glaucoma (broad definition) or ocular hypertension 10) Presence of a cancer or a serious systemic disease 11) Presence of any circulatory failure 12) Presence of corneal disorder 13) Presence of serious visual field defect 14) Presence of corneal abnormality which is considered to preclude accurate measurement of IOP by Goldmann applanation tonometer 15) History of corneal transplantation or keratorefractive surgery 16) History of allergy or significant adverse drug reaction to any ingredients of drugs used in this study
Target sample size	376

Research contact person
Name of lead principal investigator	Makoto Aihara
Organization	The University of Tokyo
Division name	Department of Ophthalmology, Graduate School of Medicine and Faculty of Medicine
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655 Japan
TEL	03-5800-6415
Email	aihara-tky@umin.net

Public contact
Name of contact person	Takuro Sekiya
Organization	Senju Pharmaceutical Co.,Ltd.
Division name	Clinical Development
Address	3-1-9, Kawara-machi, Chuo-ku, Osaka, Japan
TEL	06-6201-9605
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)

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 09 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 06 Month 29 Day
Anticipated trial start date	2017 Year 09 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 08 Month 02 Day
Last modified on	2019 Year 02 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032576