UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054820 |
|---|---|
| Receipt number | R000062640 |
| Scientific Title | Mydriatic Effects of Low Concentration Parasympatholytic Eye Drops in Normal Subjects |
| Date of disclosure of the study information | 2024/06/29 |
| Last modified on | 2024/06/29 06:35:02 |
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Basic information
Public title
Mydriatic Effects of Low Concentration Parasympatholytic Eye Drops in Normal Subjects
Acronym
Mydriatic Effects of Low Concentration Parasympatholytic Eye Drops in Normal Subjects
Scientific Title
Mydriatic Effects of Low Concentration Parasympatholytic Eye Drops in Normal Subjects
Scientific Title:Acronym
Mydriatic Effects of Low Concentration Parasympatholytic Eye Drops in Normal Subjects
Region
| Japan |
Condition
Condition
Normal subjects
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of repeated ophthalmic administration of low concentrations of parasympatholytic agents on pupil diameter in adults.
Basic objectives2
Others
Basic objectives -Others
Pharmacology study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pupil diameter changes before and after using eye drops
Key secondary outcomes
NRS
AE
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Low concentration parasympatholytic eye drop once daily for 2 days
Interventions/Control_2
Control drug administered 4 times daily for 2 weeks
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Informed consent
Pupil diameter difference within 1mm
Rocognize light reflex
Key exclusion criteria
History of serious disease
History of eye surjery or eye trauma
Use of drugs that affect the autonomic nervous system
History of drug allergy
Active eye disease
Insufficient visual acuity
Pregnant
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Shigeru |
| Middle name | |
| Last name | Kinoshita |
Organization
ShijoKarasuma-Ganka Komuro Clinic
Division name
ophthalmology
Zip code
604-8152
Address
652 Tearaimizu-cho Nakagyo-ku Kyoto
TEL
075-708-8004
shigeruk@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Kojiro |
| Middle name | |
| Last name | Imai |
Organization
Kyoto Prefectural University of Medicine
Division name
Department for Medical Innovation and Translational Medical Science
Zip code
602-8566
Address
465 Kajii-cho, kamigyo-ku, Kyoto-shi, Kyoto
TEL
075-251-5308
Homepage URL
kimai@koto.kpu-m.ac.jp
Sponsor or person
Institute
ShijoKarasuma-Ganka Komuro Clinic
Institute
Department
Personal name
Funding Source
Organization
ShijoKarasuma-Ganka Komuro Clinic
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
Kyoto Expert Ethics Committee
Address
465 Kajiicho, Hirokoji, Kawaramachi, Kamigyoku, Kyoto
Tel
075-221-2621
miki.kyotorinrishinsa@gmail.com
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
| 2024 | Year | 06 | 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
| 2024 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 28 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 29 | Day |
Last modified on
| 2024 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062640
