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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012715
Receipt No. R000014846
Scientific Title Clinical research of Alesion ophthalmic solution in patients with seasonal allergic conjunctivitis
Date of disclosure of the study information 2014/01/01
Last modified on 2015/09/08

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Basic information
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
Condition Seasonal allergic conjunctivitis
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Medical company "Keisyo Kai"
Institute
Department

Funding Source
Organization Santen Pharmaceutical Co.,Ltd
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
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
2014 Year 01 Month 01 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
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

Progress
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
Other related information

Management information
Registered date
2013 Year 12 Month 27 Day
Last modified on
2015 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014846

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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