UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026406 |
|---|---|
| Receipt number | 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 17:32:25 |
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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
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
nitta.koji7001@fukui.saiseikai.or.jp
Sponsor or person
Institute
Fukui-ken Saiseikai Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030337
