UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005931
Receipt number R000007011
Scientific Title Clinical evaluation of 0.1% olopatadine hydrochloride ophthalmic solution in pediatric patients
Date of disclosure of the study information 2011/07/05
Last modified on 2011/07/05 20:12:20

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Basic information

Public title

Clinical evaluation of 0.1% olopatadine hydrochloride ophthalmic solution in pediatric patients

Acronym

Clinical evaluation of 0.1% olopatadine hydrochloride ophthalmic solution in pediatric patients

Scientific Title

Clinical evaluation of 0.1% olopatadine hydrochloride ophthalmic solution in pediatric patients

Scientific Title:Acronym

Clinical evaluation of 0.1% olopatadine hydrochloride ophthalmic solution in pediatric patients

Region

Japan


Condition

Condition

allergic conjunctivits

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective of this study is to verify safety and examine subjective symptoms and objective findings in children with allergic conjunctival diseases receiving Patanol Ophthalmic Solution 0.1% in the test eye (1-2 drops/dose) four times a day (morning, noon, evening and bedtime) for a period of 4 weeks.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Safety:
Presence/absence of adverse reactions
Efficacy:
Alleviation in subjective symptoms and objective findings

Key secondary outcomes

Safety:
Compliance with dosing instructions (checked by interview of subjects during visit)
Efficacy:
Impressions after doses (checked by interview of subjects during visit)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Patanol Ophthalmic Solution 0.1%

Interventions/Control_2


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

7 years-old <=

Age-upper limit

16 years-old >=

Gender

Male and Female

Key inclusion criteria

1.Patients whose parents or other guardians can issue informed consent in writing prior to the study
2.Patients aged over 7 and less than 16 at the baseline
3.Patients confirmed to show type I allergy by skin reaction tests (intracutaneous test, scratch test, etc.), antigen-specific IgE antibody assay, neutrophhils in ocular discharge/conjunctival brushing specimen, and so on
4.Patients having inflammatory changes in the conjunctiva
5.Patients having subjective symptoms at the baseline (itching sensation, foreign body sensation, eye pain, etc.)

Key exclusion criteria

1.Patients having ocular itching sensation and injection (caused by disease other than allergic conjunctivitis) possibly affecting the evaluation of drug efficacy
2.Patients having retinal detachment, diabetic retinopathy or progressive retinal disease (excluding cases rated by the attending physician as causing no problem in enrollment to the study)
3.Patients with a history of ocular infection (bacterial, viral or fungal), corneal herpes or relapsing corneal erosion of sudden onset or secondary to corneal injury (excluding cases rated by the attending physician as causing no problem in enrollment to the study)
4.Patients having received continuous treatment with corticosteroid (subconjunctival injection) within 3 months (90 days) before acquisition of consent
5.Patients having received immunotherapy (desensitization, immunomodulating therapy, etc.)
6.Patients requiring continuous treatment of corticosteroid, immunosuppressors, non-steroidal anti-inflammatory agents, vasoconstrictors, anti-histamines, anti-allergy agents, herb preparations indicated for "conjunctivitis" or any ophthalmic solution other than the test product
7.Patients having undergone ocular laser therapy within 3 months (90 days) before acquisition of consent or non-laser ocular surgery within 6 months (180 days) after acquisition of consent or planned to receive surgery during the study period
8.Unilaterally blind patients (best corrected visual acuity: below 0.01)
9.Patients with a history of allergy or hypersensitivity to olopatadine hydrochloride
10.Patients necessitating the use of contact lens during the study period
11.Other patients judged by the attending physician as inappropriate for the study

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Miki Uchino

Organization

Ryogoku Eye Clinic

Division name

Ophthalmology director

Zip code


Address

4-33-12 Ryogoku Sumida-ku Tokyo, JAPAN

TEL

03-5600-6886

Email



Public contact

Name of contact person

1st name
Middle name
Last name Miki Uchino

Organization

Ryogoku Eye Clinic

Division name

Ophthalmology Director

Zip code


Address

4-33-12 Ryogoku Sumida-ku Tokyo, JAPAN

TEL


Homepage URL


Email



Sponsor or person

Institute

Alcon Japan Ltd.

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Fujishima 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



Other administrative information

Date of disclosure of the study information

2011 Year 07 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

Completed

Date of protocol fixation

2010 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

2010 Year 03 Month 01 Day

Last follow-up date

2010 Year 10 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 07 Month 05 Day

Last modified on

2011 Year 07 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007011


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name