UMIN-CTR Clinical Trial

Public title

Clinical research of Alesion ophthalmic solution in patients with seasonal allergic conjunctivitis

Acronym

Clinical research of Alesion ophthalmic solution in patients with seasonal allergic conjunctivitis

Scientific Title

Clinical research of Alesion ophthalmic solution in patients with seasonal allergic conjunctivitis

Scientific Title:Acronym

Clinical research of Alesion ophthalmic solution in patients with seasonal allergic conjunctivitis

Region

Japan

Condition

Seasonal allergic conjunctivitis

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To compare clinical efficacy of Alesion ophthalmic solution between patients with seasonal allergic conjunctivitis due to cedar pollen, who started treatment before pollen dispersal (prior treatment group) and who started treatment after pollen dispersal (standard treatment group)

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

1. Change in scores of subjective symptoms (itch sensation, foreign body sensation, congestion, lacrimation, eye mucus)
2. Change in scores of objective symptoms (JACQLQ)
3. Change in patient-reported outcomes (JACQLQ)

Key secondary outcomes

1. Frequency in use of steroid eyedrops
2. Patient diary of allergic symptoms

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Alesion ophthalmic solution is administered prior to pollen dispersal

Interventions/Control_2

Alesion ophthalmic solution is administered posterior to pollen dispersal

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

12

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients diagnosed as seasonal allergic conjunctivitis due to cedar pollen in the both eyes
2. Allergy test-positive patients (type I allergy) in the one of the following tests (test result obtained within the past 5 years can be used) :
(1) Serum antigen-specific IgE antibody assey
(2) Skin test such as intradermal test and scratch test
(3) Rapid antigen test with ImmunoCAP Rapid
3. Patients aged 12 years or older (Parental Consent is required for patients under 20 years old)
4. Sex: male and female

Key exclusion criteria

1. Patients using contact lenses with difficulty in use of ophthalmic solution
2. Patients given immunotherapy (hyposensitization therapy, modulated therapy)
3. Patients with surgical history in the internal eye (including laser therapy) within 3 months prior to enrollment
4. Patients with allergy to drugs (including fluorescein) to be used during the research
5. Patients taking medicines (including steroid and immunosuppressive drugs) which affects the efficacy of study drug within 14 days prior to enrollment (patients can use drugs except for steroid and immunosuppressive drugs unless amount of drug is changed during the research)
6. Pregnant women, women of child-bearing potential or lactating women

Target sample size

260

Name of lead principal investigator

1st name
Middle name
Last name	Kazumi Fukagawa

Organization

Medical company "Keisyo Kai"

Division name

Chairperson of the BOD

Zip code

Address

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

TEL

03-5600-6886

Email

Kafun_Chiryo@quintiles.com

Name of contact person

1st name
Middle name
Last name	Study support center

Organization

Quintiles Transnational Japan K.K.

Division name

Medical & regulatory affairs division

Zip code

Address

3-4-30 Miyahara, Yodogawa-ku, Osaka

TEL

06-4807-9800

Homepage URL

Email

Kafun_Chiryo@quintiles.com

Institute

Medical company "Keisyo Kai"

Institute

Department

Personal name

Organization

Santen Pharmaceutical Co.,Ltd

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2014

Year

01

Month

01

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

At the time of pollen dispersal peak, epinastine hydrochloride ophthalmic solution significantly controlled itch sensation, patient-reported outcomes, objective symptoms, total score of QOL (JACQLQ), and aggravation/severity of symptoms scored in QOL in the prior treatment group, compared with the standard treatment group. Based on the above result, it was considered that use of epinastine hydrochloride ophthalmic solution at early timing kept symptoms mild and is effective.

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

Recruitment status

Completed

Date of protocol fixation

2013

Year

10

Month

08

Day

Date of IRB

Anticipated trial start date

2014

Year

01

Month

01

Day

Last follow-up date

2014

Year

06

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

12

Month

27

Day

Last modified on

2015

Year

09

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014846