UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047171 |
|---|---|
| Receipt number | R000053803 |
| Scientific Title | Daily disposable silicone hydrogel contact lens survey. |
| Date of disclosure of the study information | 2022/03/14 |
| Last modified on | 2022/06/06 16:05:36 |
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Basic information
Public title
Daily disposable silicone hydrogel contact lens survey.
Acronym
Daily disposable silicone hydrogel contact lens comfort.
Scientific Title
Daily disposable silicone hydrogel contact lens survey.
Scientific Title:Acronym
Daily disposable silicone hydrogel contact lens comfort.
Region
| Japan |
Condition
Condition
Myopia and Myopic astigmatism
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Daily disposable silicone hydrogel contact lens comfort assessment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual acuity and questionnaire about comfort.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Wearing contact lenses.
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
| 15 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Aged 15 to 40 years old.
2.Subjects who are able to understand an informed consent form, in the case of minors younger than twenty, consent is obtained from their parents.
3.Subjects to whom the study lens can be prescribed within the power range.
4.Subjects with a CL corrected visual acuity of 0.7 or higher to whom the lens is a good fit.
5.Subjects who wear CL on both eyes for at least 8 hours per day and 7 days per week.
6.Subjects who have no health conditions that would be a problem for the usage of CL.
Key exclusion criteria
1.Subjects who wear a contact lens in only one eye.
2.Subjects with aphakia or eyes implanted with artificial intraocular lenses.
3.Subjects with systemic diseases that may affect the eyes.
4.Subjects using drugs that may affect visual function and CL performance.
5.Subjects with keratoconus, corneal infiltration, or corneal ulcer.
6.Subjects who have undergone corneal surgery refractive surgery, etc.
7.Subjects who are participating in other clinical studies or clinical trials, or who have participated in studies or trials in the past 30 days.
8.Subjects who the researcher in charge of the clinical trial deems unsuitable.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Tojima |
Organization
Nitten Pharmaceutical Co.,Ltd
Division name
Surgical Business Promotion Division
Zip code
105-9912
Address
2-8-13 daimon,minato-ku,Tokyto,105-0012 Japan
TEL
03-5408-5305
h-tojima@nitten-eye.co.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Tojima |
Organization
Nitten Pharmaceutical Co.,Ltd
Division name
Surgical Business Promotion Division
Zip code
105-9912
Address
2-8-13 daimon,minato-ku,Tokyto,105-0012 Japan
TEL
03-5408-5305
Homepage URL
h-tojima@nitten-eye.co.jp
Sponsor or person
Institute
Nitten Pharmaceutical Co.,Ltd
Institute
Department
Personal name
Funding Source
Organization
Nitten Pharmaceutical Co.,Ltd
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
ROHTO NITTEN Co., Ltd
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation Heishinkai OPHAC Hospital
Address
4-1-29 miyahara , yodogawa-ku , Osaka , 532-0002 Japan
Tel
06-6395-9000
sumiko.kawamoto@heishinkai.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
| 2022 | Year | 03 | Month | 14 | 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
20
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
| 2022 | Year | 02 | Month | 04 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 14 | Day |
Last modified on
| 2022 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053803
