UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of enophthalmos due to ophthalmic solution for glaucoma
Title of the study (Brief title)	Enophthalmos due to ophthalmic solution for glaucoma
Region	Japan

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

Objectives
Narrative objectives1	Evaluation of enophthalmos due to ophthalmic solution for glaucoma
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Variation on a value of proptosis
Key secondary outcomes	Variation on a volume of orbital fatty tissue

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Outpatients of Shiga University of Medical Science Hospital that start the treatment with bimatoprost ophthalmic solution for glaucoma
Key exclusion criteria	Patients who have the history of the treatment with prostaglandin ophthalmic solution Patients who can not undergo MRI examination
Target sample size	15

Research contact person
Name of lead principal investigator	Tomoaki Higashiyama
Organization	Shiga University of Medical Science
Division name	Department of Ophthalmology
Address	Seta, Tsukinowa-cho, Otsu, Shiga, Japan
TEL	0775482276
Email	higashi@belle.shiga-med.ac.jp

Public contact
Name of contact person	Tomoaki Higashiyama
Organization	Shiga University of Medical Science
Division name	Department of Ophthalmology
Address	Seta, Tsukinowa-cho, Otsu, Shiga, Japan
TEL	0775482276
Homepage URL
Email	higashi@belle.shiga-med.ac.jp

Sponsor
Institute	Department of Ophthalmology, Shiga University of Medical Science
Institute
Department

Funding Source
Organization	Scholarship donations
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 07 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 05 Month 21 Day
Anticipated trial start date	2015 Year 08 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Prospective study Cohort study Consecutive cases

Management information
Registered date	2015 Year 08 Month 07 Day
Last modified on	2017 Year 01 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021523