UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013073
Receipt number R000015244
Scientific Title Evaluation of the efficacy and safety of anti-allergic ophthalmic solution for the treatment of allergic conjunctivitis.
Date of disclosure of the study information 2014/02/05
Last modified on 2015/04/27 18:29:07

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Basic information

Public title

Evaluation of the efficacy and safety of anti-allergic ophthalmic solution for the treatment of allergic conjunctivitis.

Acronym

Evaluation of the efficacy and safety of anti-allergic ophthalmic solution for the treatment of allergic conjunctivitis.

Scientific Title

Evaluation of the efficacy and safety of anti-allergic ophthalmic solution for the treatment of allergic conjunctivitis.

Scientific Title:Acronym

Evaluation of the efficacy and safety of anti-allergic ophthalmic solution for the treatment of allergic conjunctivitis.

Region

Japan


Condition

Condition

Allergic conjunctivitis

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To make a comparative investigation of the efficacy and safety of anti-allergic ophthalmic solution for the treatment of allergic conjunctivitis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

1: Change in scores of subjective symptoms (JACQLQ)
2: Changes in scores of objective symptoms (JACQLQ)

Key secondary outcomes

1: Frequency in use of steroid eyedrops.
2: Patient diary of allergic symptoms.
3: Evaluation of the corneal safety.


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

Olopatadine hydrochloride 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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1: Patients whose both eyes are diagnosed as allergic conjunctivitis.
2: Patients who provided written informed consent for participating in this study.

Key exclusion criteria

1: Patients given immunotherapy.
2: Patients with surgical history in the internal eye (including laser therapy) within 3 months prior to enrollment.
3: Patients with allergy to drugs (including fluorescein) to be used during the research.
4: Patients taking medicines which affects the efficacy of study drug (including steroid, anti-allergic drugs and immunosuppressive drugs) during the research (patients can use drugs except for steroid and immunosuppressive drugs unless amount of drug is changed during the research).
5: Pregnant women, women of child-bearing potential or lactating women.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takanori Mizoguchi

Organization

Mizoguchi Eye Clinic

Division name

Ophthalmology

Zip code


Address

6-13 Tawara-machi Sasebo Nagasaki Japan

TEL

0956-22-5681

Email

t-mizo@siren.ocn.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takanori Mizoguchi

Organization

Mizoguchi Eye Clinic

Division name

Ophthalmology

Zip code


Address

6-13 Tawara-machi Sasebo Nagasaki Japan

TEL

0956-22-5681

Homepage URL


Email

t-mizo@siren.ocn.ne.jp


Sponsor or person

Institute

Mizoguchi Eye Clinic

Institute

Department

Personal name



Funding Source

Organization

Santen Pharmacceut

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Ozaki 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

溝口眼科(長崎県)、尾崎眼科(宮崎県)


Other administrative information

Date of disclosure of the study information

2014 Year 02 Month 05 Day


Related information

URL releasing protocol


Publication of results

Unpublished


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

Open public recruiting

Date of protocol fixation

2014 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 02 Month 10 Day

Last follow-up date

2014 Year 08 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 02 Month 05 Day

Last modified on

2015 Year 04 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015244


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name