UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of eye wash trial with Wellwasheye
Title of the study (Brief title)	Eye wash efficacy by Wellwasheye
Region	Japan

Condition
Condition	Allergic conjunctivitis disease
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effectiveness and safety of allergic conjunctiva disease by Wellwosseye
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1.Change in subjective symptom score (JACQLQ) 2.Changes in objective symptom score (JACQLQ) 3.Changes in conjunctival injection score
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Wellwasheye
Interventions/Control_2	saline solution
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	13 years-old <
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with allergic conjunctivitis disease
Key exclusion criteria	1 Patients with a past history of ocular surgery. 2. Patient who can not use eye drops.
Target sample size	30

Research contact person
Name of lead principal investigator	Tatsuya Mimura
Organization	Teikyo University
Division name	School of Medicine, Department of Ophthalmology
Address	2-11-1 Kaga, Itabashi-ku, Tokyo, 173-8605 Japan
TEL	03-3964-1211
Email	mimurat@med.teikyo-u.ac.jp

Public contact
Name of contact person	Tatsuya Mimura
Organization	Teikyo University
Division name	School of Medicine, Department of Ophthalmology
Address	2-11-1 Kaga, Itabashi-ku, Tokyo, 173-8605 Japan
TEL	03-3964-1211
Homepage URL
Email	mimurat@med.teikyo-u.ac.jp

Sponsor
Institute	Teikyo University School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Ophthalmology Tsurumi University Dental Hospital, Ryogoku Eye Clinic, Fujishima Eye Clinic
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	2019 Year 01 Month 22 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2019 Year 01 Month 22 Day
Anticipated trial start date	2019 Year 01 Month 22 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	2019 Year 01 Month 22 Day
Last modified on	2019 Year 01 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040586