UMIN-CTR Clinical Trial

Basic information
Public title	A phase III comparative study to evaluate the efficacy and safety of SJP-0135 versus timolol in patients with primary open-angle glaucoma or ocular hypertension
Acronym	A comparative study to evaluate the efficacy and safety of SJP-0135 versus timolol 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 evaluate the efficacy (intraocular pressure reduction) and safety of twice-daily dosed SJP-0135 for 4 weeks compared to 0.5% timolol ophthalmic solution in patients with primary open-angle glaucoma (broad definition) or ocular hypertension and to confirm if SJP-0135 and concurrent administration of 0.1% brimonidine tartrate and 0.5% timolol 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 baseline 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 0.5% timolol 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-0135 is instilled into each eye twice-daily (in the morning and in the evening) for 4 weeks.
Interventions/Control_2	One drop of 0.5% timolol ophthalmic solution is instilled into each eye twice-daily (in the morning and in the evening) for 4 weeks, and then one drop of 0.5% timolol is instilled into each eye twice-daily (in the morning and in the evening) for 4 weeks.
Interventions/Control_3	One drop of 0.5% timolol ophthalmic solution is instilled into each eye twice-daily (in the morning and in the evening) for 4 weeks, and then each one drop of 0.1% brimonidine tartrate and 0.5% timolol 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 in both eyes 4) Required ophthalmic solution for IOP-lowering treatment in both eyes 5) IOP =< 31.0 mmHg in each eye 6) Best corrected visual acuity >= 0.3 in each eye
Key exclusion criteria	1) Prior ocular instillation of SJP-0135 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) Presence of any active retinal disease which may progress during the study 7) Presence of any active ocular disease other than primary open-angle glaucoma (broad definition) or ocular hypertension 8) Presence of a cancer or a serious systemic disease 9) Presence of any circulatory failure such as cerebrovascular disease, orthostatic hypotension, cardiovascular disease 10) Presence or history of bronchial asthma, bronchospasm or serious chronic obstructive pulmonary disease 11) Presence or history of uncontrolled heart failure, sinus bradycardia, atrioventricular block (Grade II or III) or cardiogenic shock 12) Presence of right heart failure caused by pulmonary hypertension, congestive heart failure, diabetic ketoacidosis, metabolic acidosis or uncontrolled diabetes mellitus 13) 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 the study drug or other alpha-2 receptors agonist or other beta-adrenergic receptor antagonist
Target sample size	408

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 10 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	2017 Year 01 Month 13 Day
Date of IRB	2017 Year 03 Month 02 Day
Anticipated trial start date	2017 Year 03 Month 10 Day
Last follow-up date	2017 Year 12 Month 02 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=R000030406