UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019050 |
|---|---|
| Receipt number | R000020166 |
| Scientific Title | Study of the lens adjustment force recovery of early presbyopic eyes by pirenoxine eye drops |
| Date of disclosure of the study information | 2015/09/17 |
| Last modified on | 2017/08/01 11:23:10 |
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Basic information
Public title
Study of the lens adjustment force recovery of early presbyopic eyes by pirenoxine eye drops
Acronym
The adjustment force recovery of presbyopia
by pirenoxine eye drops
Scientific Title
Study of the lens adjustment force recovery of early presbyopic eyes by pirenoxine eye drops
Scientific Title:Acronym
The adjustment force recovery of presbyopia
by pirenoxine eye drops
Region
| Japan |
Condition
Condition
presbyopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the possibility that pirenoxine eye drops can recover the lens adjustment force.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of accommodation amplitude (subjective&objective) after 6 month administration of eye drops.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Use Kary Uni eyedrops four times a day for 6 months
Interventions/Control_2
Use Soft Santear eyedrops four times a day for 6 months
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
| 40 | years-old | <= |
Age-upper limit
| 55 | years-old | > |
Gender
Male
Key inclusion criteria
The inclusion criteria are male, patient age of 20 years and older, and no ophthalmic or systematic diseases other than refractive errors.
Key exclusion criteria
Ophthalmic or systematic diseases other than refractive errors, past ophthalmic operations, myopia of -6D or more, hyperopia.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuno Negishi |
Organization
Keio University school of medicine
Division name
Ophthalmology
Zip code
Address
35, Shinanomachi, Shinjuku-ku Tokyo
TEL
+81-3-3353-1211
fwic7788@mb.infoweb.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuno Negishi |
Organization
Keio University school of medicine
Division name
Ophthalmology
Zip code
Address
35, Shinanomachi, Shinjuku-ku Tokyo
TEL
+81-3-3353-1211
Homepage URL
fwic7788@mb.infoweb.ne.jp
Sponsor or person
Institute
Keio University School of medicine
Institute
Department
Personal name
Funding Source
Organization
Kazuno Negishi
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
Address
Tel
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
| 2015 | Year | 09 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.nature.com/articles/%20s41598-017-07208-6
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
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 17 | Day |
Last modified on
| 2017 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020166
