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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043696
Receipt No. R000049848
Scientific Title Efficacy of the combination treatment of epinastine hydrochloride 0.1% and bromfenac sodium ophthalmic solution for allergic conjunctivitis.
Date of disclosure of the study information 2021/03/29
Last modified on 2021/03/18

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Basic information
Public title Efficacy of the combination treatment of epinastine hydrochloride 0.1% and bromfenac sodium ophthalmic solution for allergic conjunctivitis.
Acronym Efficacy of the combination treatment of epinastine hydrochloride 0.1% and bromfenac sodium ophthalmic solution for allergic conjunctivitis.
Scientific Title Efficacy of the combination treatment of epinastine hydrochloride 0.1% and bromfenac sodium ophthalmic solution for allergic conjunctivitis.
Scientific Title:Acronym Efficacy of the combination treatment of epinastine hydrochloride 0.1% and bromfenac sodium ophthalmic solution for allergic conjunctivitis.
Region
Japan

Condition
Condition conjunctivitis
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the efficacy of the combination treatment of epinastine hydrochloride 0.1% and bromfenac sodium ophthalmic solution for allergic conjunctivitis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The improvement rate in conjunctivitis findings when two types of eye drops are uesd together
Key secondary outcomes The improvement rate in subjective symptoms when two types of eye drops are uesd together

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The patients are treated with epinastine hydrochloride 0.1% twice a day, and bromfenac sodium ophthalmic solution is concomitantly administered twice a day in one eye and artificial tears is administered twice a day in the contralateral eye for two weeks.
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria allergic conjunctivitis
Key exclusion criteria conjunctivitis with Stevens-Johnson syndrome
and/or proliferative atopic keratoconjunctivitis
contact lens wearers
eyes with pretreatment
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Fujishima
Organization Tsurumi University Dental Hospital
Division name Department of ophthalmology
Zip code 2308501
Address 2-1-3 Tsurumi, Tsurumi-ku, Yokohama-shi, Kanagawa 230-8501 Japan
TEL 81455808500
Email fujishima117@gmail.com

Public contact
Name of contact person
1st name Asako
Middle name
Last name Kodama
Organization Eiju General Hospital
Division name Department of ophthalmology
Zip code 1108645
Address 2-23-16 Higashiueno, Taito-ku, Tokyo 110-8645 Japan
TEL 81338338381
Homepage URL
Email asa-chanyy_4747@kmh.biglobe.ne.jp

Sponsor
Institute Tsurumi University Dental Hospital
Institute
Department

Funding Source
Organization We have no funding and conflicts of interest.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tsurumi University
Address 2-1-3 Tsurumi, Tsurumi-ku, Yokohama-shi, Kanagawa 230-8501 Japan
Tel 81455808500
Email asa-chanyy_4747@kmh.biglobe.ne.jp

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
2021 Year 03 Month 29 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
2020 Year 04 Month 01 Day
Date of IRB
2020 Year 06 Month 10 Day
Anticipated trial start date
2021 Year 02 Month 01 Day
Last follow-up date
2021 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
2021 Year 03 Month 22 Day
Last modified on
2021 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049848

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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