UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040344 |
|---|---|
| Receipt number | R000046039 |
| Scientific Title | Effect of anti-histamine eye drops on pupil diameter |
| Date of disclosure of the study information | 2020/05/09 |
| Last modified on | 2022/02/08 07:05:28 |
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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
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
hirasawa@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
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
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
Completed
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
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 05 | Month | 09 | Day |
Last modified on
| 2022 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046039
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
