UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007989 |
|---|---|
| Receipt number | R000009401 |
| Scientific Title | Clinical trial to prevent myopia progression by progressive additional soft contact lens compared with monofocal soft contact lens in children |
| Date of disclosure of the study information | 2012/06/01 |
| Last modified on | 2017/05/23 12:27:58 |
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Basic information
Public title
Clinical trial to prevent myopia progression by progressive additional soft contact lens compared with monofocal soft contact lens in children
Acronym
Clinical trial to prevent myopia progression by progressive additional soft contact lens in children
Scientific Title
Clinical trial to prevent myopia progression by progressive additional soft contact lens compared with monofocal soft contact lens in children
Scientific Title:Acronym
Clinical trial to prevent myopia progression by progressive additional soft contact lens in children
Region
| Japan |
Condition
Condition
Myopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the preventive effect of myopia progression in test group compared with control group
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Ocular refraction
Key secondary outcomes
Axial length
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
wearing progressive additional soft contact lens
Interventions/Control_2
wearing monofocal soft contact lens
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
| 6 | years-old | <= |
Age-upper limit
| 16 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Refractive error: -0.75D to -3.5D
Corrected visual acuity by spherical Spectacle lens: better than (0.7)
Key exclusion criteria
Anisometropia greater than 1.0D
Amblyopia
Strabismus
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Fujikado |
Organization
Osaka University School of Medicine
Division name
Applied Visual Science
Zip code
Address
2-2 Yamadaoka, Suita
TEL
06-6879-3941
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Fujikado |
Organization
Osaka University School of Medicine
Division name
Applied Visual Science
Zip code
Address
2-2 Yamadaoka, Suita
TEL
06-6879-3941
Homepage URL
Sponsor or person
Institute
Osaka University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Menicon Corp.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Itami central ophthalmology clinic
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
大阪大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Elongation of axial length was significantly reduced in eyes worn by low-additional
progressive contactlenses compared with monofocal contactlenses 12 months after lens wear. The original point was set after 1month of wearing.
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
Main results already published
Date of protocol fixation
| 2010 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 19 | Day |
Last modified on
| 2017 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009401
