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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002666
Receipt No. 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

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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
Email 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
Email shiki@jikei.ac.jp

Sponsor
Institute The Jikei University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003246

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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