UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002666 |
|---|---|
| Receipt number | R000003246 |
| Scientific Title | Efficacy of topical unoprostone treatment for nonarteritic anterior ischemic optic neuropathy |
| Date of disclosure of the study information | 2009/12/01 |
| Last modified on | 2019/05/08 12:04:44 |
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Basic information
Public title
Efficacy of topical unoprostone treatment for nonarteritic anterior ischemic optic neuropathy
Acronym
Topical unoprostone treatment for nonarteritic anterior ischemic optic neuropathy
Scientific Title
Efficacy of topical unoprostone treatment for nonarteritic anterior ischemic optic neuropathy
Scientific Title:Acronym
Topical unoprostone treatment for nonarteritic anterior ischemic optic neuropathy
Region
| Japan |
Condition
Condition
Nonarteritic anterior ischemic optic neuropathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of unoprostone treatment for nonarteritic anterior ischemic optic neuropathy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Mean deviation of Humphrey field analyzer at 12 months
Key secondary outcomes
Mean deviation of Humphrey field analyzer at 6 months
Visual acuity at 6, 12 months
Goldmann perimetry at 12 months
Ocular fundus at 6, 12 months
Retinal nerve fiber layer thickness using optical coherence tomography at 6, 12 months
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Unoprostone
3 drops twice a day for the first month
2 drops twice a day after the first month until 1 year
Interventions/Control_2
Control (Vitamine B12)
3 drops twice a day for the first month
2 drops twice a day after the first month until 1 year
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Aged 50 years or older
2) Duration of symptoms < 2 weeks
3) Visual loss or visual field defects consistent with optic neuropathy
4) Painless
5) Relative afferent pupillary defect
6) Optic disc edema
Key exclusion criteria
Arteritic ischemic optic neuropathy
Glaucoma
Optic neuritis
Compressive optic neuropathy
Leber hereditary optic neuropathy
Toxic and nutritional optic neuropathy
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Keigo |
| Middle name | |
| Last name | Shikishima |
Organization
The Jikei University School of Medicine
Division name
Department of Ophthalmology
Zip code
105-8461
Address
3-25-8, Nishi-shinbashi, Minato-ku
TEL
03-3433-1111
shiki@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Keigo |
| Middle name | |
| Last name | Shikishima |
Organization
The Jikei University School of Medicine
Division name
Department of Ophthalmology
Zip code
105-8461
Address
3-25-8, Nishi-shinbashi, Minato-ku
TEL
03-3433-1111
Homepage URL
shiki@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Jikei University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Jikei University School of Medicine
Address
3-25-8, Nishi-shinbashi, Minato-ku Tokyo, 105-8461, Japan
Tel
03-3433-1111
rinri@jikei.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
東京慈恵会医科大学附属病院（東京都），井上眼科病院（東京都），杏林大学医学部附属病院（東京都），鴨下眼科クリニック（東京都），清澤眼科医院（東京都），日本大学医学部附属板橋病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 12 | Month | 01 | 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 | 10 | Month | 16 | Day |
Date of IRB
| 2009 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 10 | Month | 25 | Day |
Last modified on
| 2019 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003246
