UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and efficacy study of wiping lid margins with Eye Shampoo containing menthol
Title of the study (Brief title)	Safety and efficacy study of Eye Shampoo containing menthol
Region	Japan

Condition
Condition	Subjects who would benefit from undergoing lid hygiene therapy or normal subjects
Classification by specialty	Ophthalmology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To perform a safety and efficacy study using Eye Shampoo (MediProduct) containing menthol to wipe lid margins
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	subjective symptom, tear breakup time, fluorescein staining score, meibum, lid margin findings, other related items. Evaluations are conducted at the starting point and at 2 and 3 months.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Safety and efficacy are verified at the Ophthalmology Department by performing estimations before and after wiping lid margins using tap-water alone.
Interventions/Control_2	Safety and efficacy are verified at the Ophthalmology Department by performing estimations before and after wiping lid margins using tap-water together with Eye Shampoo (MediProduct) containing menthol.
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	Subjects who agree to the ophthalmological examinations
Key exclusion criteria	Subjects who are judged to have poor understanding or who are unlikely to perform the required tasks of the study
Target sample size	50

Research contact person
Name of lead principal investigator	Hirotaka Tanabe
Organization	Ashikaga Red Cross Hospital
Division name	Ophthalmology
Address	284-1, Yobecho Ashikaga, Tochigi, 326-0843 Japan
TEL	+81-284210121
Email	tennsyoudragon@icloud.com

Public contact
Name of contact person	Hirotaka Tanabe
Organization	Ashikaga Red Cross Hospital
Division name	Ophthalmology
Address	284-1, Yobecho Ashikaga, Tochigi, 326-0843 Japan
TEL	+81-284210121
Homepage URL
Email	tennsyoudragon@icloud.com

Sponsor
Institute	Department of Ophthalmology, Ashikaga Red Cross Hospital
Institute
Department

Funding Source
Organization	Department of Ophthalmology, Keio University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Ophthalmology, Keio University School of Medicine (Tokyo), Ishida Eye Clinic (Shizuoka), Wada Eye Clinic (Chiba)
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	慶應義塾大学眼科（東京都）、いしだ眼科（静岡県）、和田眼科（千葉県） / Department of Ophthalmology, Keio University School of Medicine (Tokyo), Ishida Eye Clinic (Shizuoka), Wada Eye Clinic (Chiba)

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 13 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 05 Month 01 Day
Anticipated trial start date	2016 Year 05 Month 13 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

Management information
Registered date	2016 Year 05 Month 13 Day
Last modified on	2018 Year 11 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025615