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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026472
Receipt No. R000030406
Scientific 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
Date of disclosure of the study information 2017/03/10
Last modified on 2019/03/11

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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 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
Scientific Title: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
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
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
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
Outcome 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/ctr_e/ctr_view.cgi?recptno=R000030406

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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