UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022741 |
|---|---|
| Receipt number | R000026201 |
| Scientific Title | Association between Genetic Polymorphisms of Core Clock Genes and 24-hour IOP-related profile in Japanese Normal-Tension Glaucoma |
| Date of disclosure of the study information | 2016/06/24 |
| Last modified on | 2023/12/21 16:40:09 |
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Basic information
Public title
Association between Genetic Polymorphisms of Core Clock Genes and 24-hour IOP-related profile in Japanese Normal-Tension Glaucoma
Acronym
Association between core clock genes and 24hr IOP related profile in Japanese NTG
Scientific Title
Association between Genetic Polymorphisms of Core Clock Genes and 24-hour IOP-related profile in Japanese Normal-Tension Glaucoma
Scientific Title:Acronym
Association between core clock genes and 24hr IOP related profile in Japanese NTG
Region
| Japan |
Condition
Condition
Normal tension glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate relationships between genetic polymorphisms of clock genes and 24-hour IOP-related profile.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Genetic polymorphisms of core clock genes and 24-hour IOP related profile
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Gene | Device,equipment |
Interventions/Control_1
The IOP-related profile will be measured using a contact lens sensor (CLS, SENSIMED Triggerfish; Sensimed AG, Lausanne, Switzerland) in the eye with the greater visual field defect based on mean deviation value.
Genotyping of polymorphisms of core clock genes (BMAL1, CLOCK, PER1, PER2, PER3, CRY1 and CRY2) will be performed.
Genomic DNA will be extracted from peripheral leukocytes by standard methods in each patient.
Interventions/Control_2
Interventions/Control_3
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
Subjects will be Japanese patients diagnosed with normal tension glaucoma (NTG) in the Department of Ophthalmology, Kanazawa University Hospital, Kanazawa, Japan. All the subjects included in this study will be off antiglaucoma medication treatment for at least 4 weeks before the diurnal intraocular pressure (IOP) measurements in this study.
Key exclusion criteria
Patients with systemic administration of alpha or beta-adrenergic antagonists or history of ocular surgery except for cataract extraction will be excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tomomi |
| Middle name | |
| Last name | Higashide |
Organization
Kanazawa University Graduate School of Medical Sciences
Division name
Department of Ophthalmology
Zip code
9208641
Address
13-1 Takaramachi Kanazawa 9208641 Japan
TEL
0762652403
eyetomo@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomomi |
| Middle name | |
| Last name | Higashide |
Organization
Kanazawa University Graduate School of Medical Sciences
Division name
Department of Ophthalmology
Zip code
9208641
Address
13-1 Takaramachi Kanazawa 9208641 Japan
TEL
0762652403
Homepage URL
eyetomo@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
SENSIMED
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Kanazawa University Hospital
Address
13-1 Takaramachi Kanazawa 9208641 Japan
Tel
0762652110
rinri@adm.kanazawa-u.ac.jp
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
金沢大学附属病院（石川県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 24 | 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
100
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
There has been a delay in publishing the results in a scientific paper.
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 15 | Day |
Last modified on
| 2023 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026201
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
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