UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057126 |
|---|---|
| Receipt number | R000065297 |
| Scientific Title | Assessment of subjective ratings and clinical findings in PRECISION1 sphere. |
| Date of disclosure of the study information | 2025/02/25 |
| Last modified on | 2025/09/01 17:55:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Assessment of subjective ratings and clinical findings in satisfied 1-Day daily disposable contact lens wearers switching to PRECISION1 sphere.
Acronym
Assessment of subjective ratings and clinical findings in PRECISION1 sphere.
Scientific Title
Assessment of subjective ratings and clinical findings in PRECISION1 sphere.
Scientific Title:Acronym
Assessment of subjective ratings and clinical findings in PRECISION1 sphere.
Region
| Japan |
Condition
Condition
mypopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the subjective ratings and objective endpoints with the current senofilcon A (Oasys 1 Day) sphere wearers after they have been prescribed into verofilcon A sphere in a Japanese population.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective rating of satisfaction (Likert) scores with verofilcon A sphere.
Non-invasive tear break up time (NIBUT).
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. 18-40 years old, read and signed an information consent letter.
2. Habitual Oasys 1 Day sphere wearers (for at least 5 days/week and at least 8hours/day during the study period)
3. Verified screening criteria: Subjective satisfaction.
4. The participant who achieves a best corrected visual acuity of at least 0.1 logMAR in both eyes with P1
5. Spherical refraction of -1.00 to -6.00 and astigmatism of 0.50D or less after vertex correction in both eyes
6. Digital devices use at least 4 hours or over any combination of digital devices such as PC, laptop, smartphone, or tablet/ day.
7. Able to participate study visit.
Key exclusion criteria
1. With eye disease and/or infection
2. Patients who fulfill both of the following two conditions to be diagnosed with dry eye*, (1) subjective symptoms such as ocular discomfort and visual disfunction and (2) FBUT less than 5 seconds. * Definition and Diagnosis of Dry Eye in Japan, 2016.
3. Those who have undergone surgery for refractive error.
4. With systemic diseases that may affect test results, or those using eye drops or oral medications.
5. Those who concurrently participating in clinical trials or research involving interventional or invasive eye examinations.
6. Pregnant or lactating at the time of study enrollment.
Target sample size
56
Research contact person
Name of lead principal investigator
| 1st name | Hisataka |
| Middle name | |
| Last name | Fujimoto |
Organization
Inoue eye clinic
Division name
Ophthalmology
Zip code
706-0011
Address
Tamano Uno 1-14-31, Okayama, Japan
TEL
0863-31-1030
fujimohis1000@gmail.com
Public contact
Name of contact person
| 1st name | Hisataka |
| Middle name | |
| Last name | Fujimoto |
Organization
Inoue eye clinic
Division name
Ophthalmology
Zip code
706-0011
Address
Tamano Uno 1-14-31, Okayama, Japan
TEL
0863-31-1030
Homepage URL
fujimohis1000@gmail.com
Sponsor or person
Institute
Inoue eye clinic
Institute
Department
Personal name
Funding Source
Organization
Inoue eye clinic
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Inoue eye clinic
Address
Tamano Uno 1-14-31, Okayama, Japan
Tel
0863-31-1030
fujimohis1000@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
| 2025 | Year | 02 | Month | 25 | 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
| 2025 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study.
Management information
Registered date
| 2025 | Year | 02 | Month | 25 | Day |
Last modified on
| 2025 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065297
