UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013173
Receipt No. R000014636
Scientific Title Evaluation of efficacy of anti-allergic ophthalmic solution for allergic conjunctival diseases using the allergic conjunctival disease medical treatment assessment system.
Date of disclosure of the study information 2014/02/16
Last modified on 2017/02/21

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Evaluation of efficacy of anti-allergic ophthalmic solution for allergic conjunctival diseases using the allergic conjunctival disease medical treatment assessment system.
Acronym Evaluation of efficacy of anti-allergic ophthalmic solution for allergic conjunctival diseases.
Scientific Title Evaluation of efficacy of anti-allergic ophthalmic solution for allergic conjunctival diseases using the allergic conjunctival disease medical treatment assessment system.
Scientific Title:Acronym 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
1st name
Middle name
Last name Jun Shoji
Organization Nihon University School of Medicine
Division name Division of Ophthalmology, Department of Visual Sciences
Zip code
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
1st name
Middle name
Last name Jun Shoji
Organization Nihon University School of Medicine
Division name Division of Ophthalmology, Department of Visual Sciences
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 11 Month 15 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000014636

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.