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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026406
Receipt No. R000030337
Scientific Title The retrospective clinical study on inhibitory effect of 0.1% brimonidine ophthalmic solution against the optic disc hemorrhage
Date of disclosure of the study information 2017/03/15
Last modified on 2017/03/05

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Basic information
Public title The retrospective clinical study on inhibitory effect of 0.1% brimonidine ophthalmic solution against the optic disc hemorrhage
Acronym Inhibitory effect of 0.1% brimonidine ophthalmic solution against the optic disc hemorrhage
Scientific Title The retrospective clinical study on inhibitory effect of 0.1% brimonidine ophthalmic solution against the optic disc hemorrhage
Scientific Title:Acronym Inhibitory effect of 0.1% brimonidine ophthalmic solution against the optic disc hemorrhage
Region
Japan

Condition
Condition Glaucoma
Classification by specialty
Ophthalmology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Inhibitory effect of 0.1% brimonidine ophthalmic solution against a patient with medical history of the optic disc hemorrhage (DH) is examined by the retrospective clinical study.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Comparison with the frequency of DH before and after addition of 0.1% brimonidine.
Key secondary outcomes 1) Ratio of frequency of DH occurrence
2) Intraocular pressure with Goldmann applanation tonometer

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients being treated for more than two years.
2)Patients administered with additional brimonidine for more than one year.
3)Patients with optic disc hemorrhage before administration of additional brimonidine.
4)Patients who had no addition or change with glaucoma therapeutic drugs except for addition of brimonidine addition and the end date of observation period. (If both eyes constitute indication, worse eye is chosen.)
Key exclusion criteria 1)Patients with retinal disease.
2)Patients with corneal opacity.
3)Patients who underwent LASIK surgery.
4)Patients that cannot be enforced with accurate visual field tests.
5)Patients with MD value -25dB or below.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Nitta
Organization Fukui-ken Saiseikai Hospital
Division name Ophthalmology
Zip code
Address Funabashi7-1, Wadanakamachi, Fukui city, Fukui
TEL 0776-23-1111
Email nitta.koji7001@fukui.saiseikai.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Nitta
Organization Fukui-ken Saiseikai Hospital
Division name Ophthalmology
Zip code
Address Funabashi7-1, Wadanakamachi, Fukui city, Fukui
TEL 0776-23-1111
Homepage URL
Email nitta.koji7001@fukui.saiseikai.or.jp

Sponsor
Institute Fukui-ken Saiseikai Hospital
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 Shimamoto Ophthalmology Clinic (Fukui)
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 福井県済生会病院 島本眼科医院

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

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
2015 Year 11 Month 25 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 25 Day
Last follow-up date
2016 Year 05 Month 11 Day
Date of closure to data entry
2016 Year 05 Month 11 Day
Date trial data considered complete
2016 Year 09 Month 27 Day
Date analysis concluded
2016 Year 10 Month 05 Day

Other
Other related information Retrospective study
Comparison with the frequency of DH before and after addtion of brimonidine ophthalmic solution.

Management information
Registered date
2017 Year 03 Month 05 Day
Last modified on
2017 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030337

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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