UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026472 |
|---|---|
| Receipt number | 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 12:20:00 |
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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
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
t-sekiya@senju.co.jp
Sponsor or person
Institute
Senju Pharmaceutical co.,ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030406
