UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018866 |
|---|---|
| Receipt number | R000021819 |
| Scientific Title | Phase IIb study of SNJ-1656; A dose-response study in patients with primary open angle glaucoma or ocular hypertension |
| Date of disclosure of the study information | 2015/08/31 |
| Last modified on | 2015/09/02 12:14:58 |
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Basic information
Public title
Phase IIb study of SNJ-1656; A dose-response study in patients with primary open angle glaucoma or ocular hypertension
Acronym
A dose-response study of SNJ-1656 in patients with primary open angle glaucoma or ocular hypertension
Scientific Title
Phase IIb study of SNJ-1656; A dose-response study in patients with primary open angle glaucoma or ocular hypertension
Scientific Title:Acronym
A dose-response study of SNJ-1656 in patients with primary open angle glaucoma or ocular hypertension
Region
| Japan |
Condition
Condition
Primary open-angle glaucoma (POAG) or Ocular hypertension (OH)
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the dose-response relationship of ocular hypotensive efficacy and safety of SNJ-1656 0.003%, 0.01%, 0.03% or SNJ-1656 vehicle given b.i.d. for 4 weeks in patients with POAG or OH.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mean change from baseline intraocular pressure (IOP) at week 4 (Hour 0 and 2)
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
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
0.003% SNJ-1656 instilled in both eyes, b.i.d. for 4 weeks.
Interventions/Control_2
0.01% SNJ-1656 instilled in both eyes, b.i.d. for 4 weeks.
Interventions/Control_3
0.03% SNJ-1656 instilled in both eyes, b.i.d. for 4 weeks.
Interventions/Control_4
Vehicle instilled in both eyes, b.i.d. for 4 weeks.
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)Patients had POAG or OH
2)IOP (hour 0)
POAG:IOP of >=18.0 mmHg and <= 31.0 mmHg
OH:IOP of >= 22.0 mmHg and <= 31.0 mmHg
3)Best corrected visual acuity of 0.5 or better
4)Patients who are completed designated washout at confirmation date of IOP
5)Change from baseline IOP (hour 0) at confirmation date of IOP <= 3.0 mmHg
Key exclusion criteria
1)Active retinal disease
2)History of keratorefractive surgery or filtering surgery
3)History of trabeculotomy or laser trabeculoplasty in the study eye
4)Highly visual field loss
5)Corneal abnormalities that would preclude accurate readings with an applanation tonometer
6)Ocular surgery within 90 days
7)Use of contact lenses
8)Any active ocular disease other than glaucoma or OH
9)Uncontrolled systemic disease (eg, hepatic, renal, cardiovascular or endocrine system disease)
10)Women who were pregnant, nursing or who were of childbearing potential, or planning a pregnancy
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidenobu Tanihara |
Organization
Kumamoto university
Division name
Department of Ophthalmology, Faculty of Life Sciences
Zip code
Address
1-1-1, Honjo, Chuo-ku, Kumamoto city 860-8556, Japan
TEL
096-373-5247
ganka@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoko Minagawa |
Organization
Senju Pharmaceutical co.,ltd.
Division name
Clinical Development
Zip code
Address
2-5-8,Hirano-machi, Chuo-ku, Osaka 541-0046, Japan
TEL
06-6201-9605
Homepage URL
yoko_minagawa@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
| 2015 | Year | 08 | Month | 31 | 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
| 2009 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | 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
| 2015 | Year | 08 | Month | 31 | Day |
Last modified on
| 2015 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021819
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