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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028494
Receipt No. R000032576
Scientific Title 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
Date of disclosure of the study information 2017/09/16
Last modified on 2019/02/04

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Basic information
Public title 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
Acronym A comparative study to evaluate the efficacy and safety of SJP-0125 versus brinzolamide in patients with primary open-angle glaucoma or ocular hypertension
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Makoto Aihara
Organization The University of Tokyo
Division name Department of Ophthalmology, Graduate School of Medicine and Faculty of Medicine
Zip code
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
1st name
Middle name
Last name Takuro Sekiya
Organization Senju Pharmaceutical Co.,Ltd.
Division name Clinical Development
Zip code
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)

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 09 Month 16 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
2017 Year 06 Month 29 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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