UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Correlation between the change of the ocular surface and the corneal sensory nerve disorder in patients receiving glaucoma therapy drugs.
Title of the study (Brief title)	Corneal sensory neuropathy in patients receiving glaucoma therapy drugs.
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study is to observe correlation between the change of the ocular surface and the corneal sensory nerve disorder in patients receiving glaucoma therapy drugs.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	To evaluate differences in long nerve fiber density (LNFD) of corneal parameters between glaucoma patients and controls using in vivo confocal microscopy. Glaucoma patients are sub-grouped according to the period of usage of eye drops.
Key secondary outcomes	corneal sensitivity, epithelial staining, tear volume, etc.

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	1)Primary open angle glaucoma or ocular hypertension. 2)Patients have been treated with prostaglandine analogs monotherapy.
Key exclusion criteria	1) Any active ocular disease. 2) Subjects unable to tolerate HRTII-RCM. 3) Previous ocular surgery orlaser treatment 4)Patients whom doctor judged to be ineligible for this study.
Target sample size	100

Research contact person
Name of lead principal investigator	Atsushi Shiraishi
Organization	Ehime University
Division name	Ophthalmology
Address	Shizukawa, Toon, Ehime, Japan
TEL	089-960-5361
Email	shiraia@m.ehime-u.ac.jp

Public contact
Name of contact person	Xiaodong Zheng
Organization	Ehime University
Division name	Ophthalmology
Address	Shizukawa, Toon, Ehime, Japan
TEL	089-960-5361
Homepage URL
Email	zheng.xiaodong401@gmail.com

Sponsor
Institute	Department of Ophthalmology, Ehime University
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
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	愛媛大学医学部附属病院（愛媛県）、南松山病院（愛媛県）

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 01 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 05 Month 10 Day
Anticipated trial start date	2016 Year 09 Month 01 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	Observed research. This study is evaluated changes of corneal parameters using confocal microscopy and ocular surface in treated glaucoma patients.

Management information
Registered date	2016 Year 08 Month 23 Day
Last modified on	2016 Year 11 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027326