UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013173
Receipt number 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 01:46:50

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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