UMIN-CTR Clinical Trial

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	Completed
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	2022 Year 09 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049848