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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009648
Receipt No. R000011323
Scientific Title Phase IIa study of SNJ-1656; An exploration study in patients with primary open angle glaucoma or ocular hypertension
Date of disclosure of the study information 2012/12/27
Last modified on 2012/12/27

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Basic information
Public title Phase IIa study of SNJ-1656; An exploration study in patients with primary open angle glaucoma or ocular hypertension
Acronym An exploration study of SNJ-1656 in patients with primary open angle glaucoma or ocular hypertension
Scientific Title Phase IIa study of SNJ-1656; An exploration study in patients with primary open angle glaucoma or ocular hypertension
Scientific Title:Acronym An exploration 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 determine the ocular hypotensive efficacy and safety of SNJ-1656 0.03%, 0.05%, 0.1% or SNJ-1656 vehicle given b.i.d. for 7 days 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 changes from baseline Intraocular pressure (IOP) at day 7 (Hour 0 and 2)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 0.03% SNJ-1656 instilled in both eyes, b.i.d. for 7 days.
Interventions/Control_2 0.05% SNJ-1656 instilled in both eyes, b.i.d. for 7 days.
Interventions/Control_3 0.1% SNJ-1656 instilled in both eyes, b.i.d. for 7 days.
Interventions/Control_4 Vehicle instilled in both eyes, b.i.d. for 7 days.
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1)Patients had POAG or OH
2)Patents were likely to be controlled on glaucoma medication
3)IOP (hour 0) of >=22.0 mmHg and <=31.0 mmHg
4)Best corrected visual acuity of 0.5 or better
Key exclusion criteria 1)Any active ocular disease other than glaucoma or OH
2)Active retinal disease
3)Ocular surgery within 3 months
4)History of keratorefractive surgery or filtering surgery
5)History of trabeculotomy in the study eye
6)Anticipated wearing of contact lenses
7)Uncontrolled systemic disease (eg, hepatic, renal, cardiovascular or endocrine system disease)
8)Women who were pregnant, nursing or who were of childbearing potential, or planning a pregnancy
9)Highly visual field loss (eg, the mean deviation <=15dB)
10)Corneal abnormalities that would preclude accurate readings with an applanation tonometer
Target sample size 60

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
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Senju Pharmaceutical co.,ltd.
Division name Strategic Development Group, Regulatory Science Div.
Zip code
Address 2-5-8,Hirano-machi, Chuo-ku, Osaka 541-0046, Japan
TEL
Homepage URL
Email

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
2012 Year 12 Month 27 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
2006 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date
2008 Year 05 Month 08 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
2012 Year 12 Month 27 Day
Last modified on
2012 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011323

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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