UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The retrospective study of inhibitory effect on optic disc hemorrhage of anti glaucoma drugs
Title of the study (Brief title)	Inhibitory effect of anti glaucoma drugs on optic disc hemorrhage
Region	Japan

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

Objectives
Narrative objectives1	This retrospective study aims to evaluate the effect of anti glaucoma drugs excluded 0.1% brimonidine on optic disc hemorrhage(DH) in the glaucoma patients with a history of DH.
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 anti glaucoma ophthalmic solution
Key secondary outcomes	1) Ratio of frequency of DH occurence 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 anti glaucoma ophthalmic solution for more than one year. 3)Patients with optic disc hemorrhage before administration of additional anti glaucoma ophthalmic solution 4)Patients who had no addition or change with glaucoma therapeutic drugs in the peroid between the day of anti glaucoma ophthalmic solution 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 who are undergoing glaucoma surgery within the observation period since the addition of anti glaucoma ophthalmic solution 5) Patients who were inability to take visual field test in accuracy 6)Patients with MD value -25dB or below.
Target sample size	40

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

Public contact
Name of contact person	Koji Nitta
Organization	Fukui-ken Saiseikai Hospital
Division name	Ophthalmology
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)

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　Fukui-ken Saiseikai Hospital　Shimamoto Ophthalmology Clinic (Fukui)

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 18 Day
Anticipated trial start date	2016 Year 12 Month 14 Day
Last follow-up date	2017 Year 04 Month 24 Day
Date of closure to data entry	2017 Year 07 Month 03 Day
Date trial data considered complete	2017 Year 07 Month 28 Day
Date analysis concluded	2017 Year 08 Month 21 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	nothing

Management information
Registered date	2017 Year 09 Month 07 Day
Last modified on	2017 Year 09 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033223