UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042265 |
|---|---|
| Receipt number | R000048253 |
| Scientific Title | Evaluation of subjective comfort and lens fit characteristics of daily disposable silicone hydrogel contact lenses (Precision 1) in first time contact lens wearing. |
| Date of disclosure of the study information | 2020/10/28 |
| Last modified on | 2020/10/28 11:20:32 |
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Basic information
Public title
Evaluation of subjective comfort and lens fit characteristics of daily disposable silicone hydrogel contact lenses (Precision 1) in first time contact lens wearing.
Acronym
Subjective comfort of daily disposable silicone hydrogel contact lenses in first time contact lens wearing.
Scientific Title
Evaluation of subjective comfort and lens fit characteristics of daily disposable silicone hydrogel contact lenses (Precision 1) in first time contact lens wearing.
Scientific Title:Acronym
Subjective comfort of daily disposable silicone hydrogel contact lenses in first time contact lens wearing.
Region
| Japan |
Condition
Condition
Myopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate subjective comfort and lens fit characteristics of Precision 1 in first-time CL users.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)Corrective visual acuity
2)Lens centration/ fit
3)Subjective comfort
4)Subjective vision (QOV)
5)Convenience in wearing and removal of study lenses
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
| 13 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Aged 13 to 40 years old must sign the informed consent.
2. Habitual eyeglasses wearers for vision correction and have never worn any contact lenses prior to enroll this clinical study.
3. Required lenses within the power range of study lenses to be fitted (-0.50D to -6.00D).
4. Vision correctable 0.8 (20/25) or better in each eye at distance with pre-study contact lenses at Baseline.
5. Have interest in wearing contact lenses as "very interested" or "fairly interested" and are willing to wear contact lenses for at least 8 hours per day and 5 days per week.
Key exclusion criteria
1. Subjects with systemic diseases or ocular diseases, including dry eyes.
2. Subjects with a history of eye surgery/trauma local or systemic antibiotic or corticosteroid, immunomodulatory current medication, pregnancy or breastfeeding within 6 months of the enrollment visit.
3. Monocular subjects (only one eye with functional vision) or subjects fit with only one lens.
4. Participation in any clinical trial within 30 days of the enrollment visit.
5. Patient who in judged ineligible as patients in this clinical study by the investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Mimura |
Organization
Teikyo University
Division name
School of Medicine, Department of Ophthalmology
Zip code
173-8605
Address
2-11-1 Kaga, Itabashi-ku, Tokyo, 173-8605 Japan
TEL
03-3964-1211
mimurat@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Mimura |
Organization
Teikyo University
Division name
School of Medicine, Department of Ophthalmology
Zip code
173-8605
Address
2-11-1 Kaga, Itabashi-ku, Tokyo, 173-8605 Japan
TEL
03-3964-1211
Homepage URL
mimurat@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
Funding Source
Organization
Teikyo University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nerima West Eye Clinic
Name of secondary funder(s)
Alcon Japan Ltd.
IRB Contact (For public release)
Organization
Teikyo University
Address
2-11-1 Kaga, Itabashi-ku, Tokyo, 173-8605 Japan
Tel
03-3964-1211
mimurat@med.teikyo-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 | 10 | Month | 28 | 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
| 2020 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 28 | Day |
Last modified on
| 2020 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048253
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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