UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of efficacy of anti-allergic ophthalmic solution for allergic conjunctival diseases using the allergic conjunctival disease medical treatment assessment system.
Title of the study (Brief title)	Evaluation of efficacy of anti-allergic ophthalmic solution for allergic conjunctival diseases.
Region	Japan

Condition
Condition	Allergic conjunctival diseases
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigation of efficacy of anti-allergic ophthalmic solution in allergic conjunctival diseases using allergic conjunctival diseases medical treatment assessment system consisting of symptom score, objective score and ocular surface clinical examinations.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Comparative study on therapeutic efficacy of anti-allergic ophthalmic solution for allergic conjunctival diseases using allergic conjunctival diseases therapeutic assessment system.
Key secondary outcomes	Investigation of useful biomarker in tears or ocular surface for allergic conjunctival disease practice by the comparison between objective finding and ocular surface clinical examination.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Epinastine hydrochloride ophthalmic solution
Interventions/Control_2	Sodium cromoglicate ophthalmic 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	4 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with allergic conjunctival diseases 1) Male or female of age of 4 years or older. 2) Patients who provided written informed consent for participating in this study. 3) Patients who are diagnosed as allergic conjunctival diseases according to the guideline for allergic conjunctival diseases in Japan.
Key exclusion criteria	1) Patients with anterior segment disease (including blepharitis, lagophthalmos, blepharospasm, iritis and conjunctivochalasis) other than allergic conjunctival diseases at the study initiation. 2) Patients who cannot discontinue eye drops (include all eye drops such as prescribed drug and OTC medicine) except for the study drug or the control drug from the study initiation until the end of study treatment or who expect to use those drugs 3) Patients with a history of surgery of the ocular surface within 12 months or patients with a history of intraocular surgery within three months prior to the study drug initiation examination. 4) Patients who have difficulty in sampling. 5) Patients that a study supervisor or a study partaker judged participation in this study to be inappropriate
Target sample size	60

Research contact person
Name of lead principal investigator	Jun Shoji
Organization	Nihon University School of Medicine
Division name	Division of Ophthalmology, Department of Visual Sciences
Address	30-1 Oyaguchi-kacho, Itabashi-ku, Tokyo, Japan
TEL	03-3972-8111
Email	shojig3589eye@athena.ocn.ne.jp

Public contact
Name of contact person	Jun Shoji
Organization	Nihon University School of Medicine
Division name	Division of Ophthalmology, Department of Visual Sciences
Address	30-1 Oyaguchi-kacho, Itabashi-ku, Tokyo, Japan
TEL	03-3972-8111
Homepage URL
Email	shojig3589eye@athena.ocn.ne.jp

Sponsor
Institute	Division of Ophthalmology, Department of Visual Sciences, Nihon University School of Medicine.
Institute
Department

Funding Source
Organization	Santen Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Shoji 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	日本大学医学部付属板橋病院（東京都）

Other administrative information
Date of disclosure of the study information	2014 Year 02 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 11 Month 15 Day
Anticipated trial start date	2014 Year 02 Month 16 Day
Last follow-up date	2015 Year 03 Month 31 Day
Date of closure to data entry	2015 Year 04 Month 30 Day
Date trial data considered complete	2015 Year 05 Month 31 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 02 Month 16 Day
Last modified on	2017 Year 02 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014636