UMIN-CTR Clinical Trial

Basic information
Public title	Effect of anti-histamine eye drops on pupil diameter
Acronym	Effect of anti-histamine eye drops on pupil diameter
Scientific Title	Effect of anti-histamine eye drops on pupil diameter
Scientific Title:Acronym	Effect of anti-histamine eye drops on pupil diameter
Region	Japan

Condition
Condition	Patients who are prescribed epinastine hydrochloride eye-drops and have a funds examination.
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of epinastine hydrochloride eye-drops on pupil diameter
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison among the pupil diameter of original pupil, after instillation of Tropicamide Phenylephrine hydrochloride (TPH), and after instillation of TPH and Epinastine hydrochloride eye-drops.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	The patient who does not meet exclusion criteria.
Key exclusion criteria	1.Iris atrophy, macular disease, corneal opacity, shallow anterior chamber or cataract with Emery-Little classification 3 or higher. 2. Existing diagnosis of cardiovascular disease. 3. A history of allergy to mydriatic drugs 4. Those who are being treated with eye drops due to glaucoma
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Hitoshi Middle name Last name Ishikawa
Organization	Kitasato University
Division name	Department of Orthoptics and Visual Science, School of Allied Health Sciences
Zip code	252-0373
Address	1-15-1 Kitasato, Minami-ku, Sagamihara Kanagawa
TEL	0427789671
Email	hitoshi@kitasato-u.ac.jp

Public contact
Name of contact person	1st name Kazunori Middle name Hirasawa Last name Hirasawa
Organization	Kitasato University
Division name	Department of Ophthalmology, School of Medicine
Zip code	252-0373
Address	1-15-1 Kitasato, Minami-ku, Sagamihara Kanagawa
TEL	0427788464
Homepage URL
Email	hirasawa@kitasato-u.ac.jp

Sponsor
Institute	Kitasato University
Institute
Department

Funding Source
Organization	Kitasato University, research grant
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	Kitasato University Hospital Ethics Committee
Address	1-15-1 Kitasato, Minami-ku, Sagamihara Kanagawa
Tel	042-778-8273
Email	rinrib@med.kitasato-u.ac.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	2020 Year 05 Month 09 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	Enrolling by invitation
Date of protocol fixation	2020 Year 04 Month 10 Day
Date of IRB	2020 Year 07 Month 08 Day
Anticipated trial start date	2020 Year 07 Month 09 Day
Last follow-up date	2023 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2020 Year 05 Month 09 Day
Last modified on	2020 Year 11 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046039

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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