UMIN-CTR Clinical Trial

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
Last 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
1st 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