UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046034 |
|---|---|
| Receipt number | R000041276 |
| Scientific Title | Superiority of tear flow dynamics in DAILIES TOTAL1 with three layered structure |
| Date of disclosure of the study information | 2021/11/11 |
| Last modified on | 2021/11/11 06:59:56 |
* 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
Superiority of tear flow dynamics in DAILIES TOTAL1 with three layered structure
Acronym
Superiority of tear flow dynamics in DAILIES TOTAL1 with three layered structure
Scientific Title
Superiority of tear flow dynamics in DAILIES TOTAL1 with three layered structure
Scientific Title:Acronym
Superiority of tear flow dynamics in DAILIES TOTAL1 with three layered structure
Region
| Japan |
Condition
Condition
SCL user
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We verify the superiority of tear flow dynamics with the subjects who were prescribed with DAILIES TOTAL1 by using the methods reported by the applicant.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
NIBUT
Tear Break up pattern
Tear film thickness
SCL thickness
Tear meniscus height
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
| 20 | years-old | <= |
Age-upper limit
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Without active ocular surface disease
Key exclusion criteria
With active ocular surface disease
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hisataka |
| Middle name | |
| Last name | Fujimoto |
Organization
Kawasaki Medical School
Division name
Department of Ophthalmology
Zip code
701-0192
Address
Matsushima 577, Kurashiki
TEL
0864621111
fujimoto-h@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Hisataka |
| Middle name | |
| Last name | Fujimoto |
Organization
Kawasaki Medical School
Division name
Department of Ophthalmology
Zip code
701-0192
Address
Matsushima 577, Kurashiki
TEL
0864621111
Homepage URL
fujimohis@yahoo.co.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Alcon
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Medical School
Address
Matsushima 577, Kurashiki
Tel
0864621111
fujimohis@yahoo.co.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
| 2021 | Year | 11 | Month | 11 | Day |
Related information
URL releasing protocol
https://tvst.arvojournals.org/article.aspx?articleid=2777865
Publication of results
Partially published
Result
URL related to results and publications
https://tvst.arvojournals.org/article.aspx?articleid=2777865
Number of participants that the trial has enrolled
50
Results
Results: TALB was significantly reduced in the delefilcon A group compared to the narafilcon A group (33.3% vs. 85.5% at v1; P < 0.0001 and 31.7% vs. 80.4% at v2; P < 0.0001).
Results date posted
| 2021 | Year | 11 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This retrospective observational study included 50 regular SH-SCL asymptomatic users. The study was approved by the institutional review board of Kawasaki Medical School Hospital (approval number 3403). Informed consent was obtained from all the study participants, and the study adhered to the tenets of the Declaration of Helsinki and was performed according to Good Clinical Practice (GCP). The study end points were evaluated by the researchers in a masked manner. The identity of the sponsor of the study (Alcon) was masked to the assessors until the completion of the study. This study did not involve patients or the public in its design, participant recruitment, or conduct.
Participant flow
The study observation period was defined as the date from which the patient started receiving care at the study site until the last data point was measured and was between May 1, 2019, and February 29, 2020. To ensure uniform data collection, assessment, and compliance with GCP, onsite training was conducted. The patient data records were selected based on the study inclusion and exclusion criteria and the patients receiving care between May 1, 2019, and February 29, 2020, were included in the study. To minimize bias, the eligible patients were enrolled in one of the two study groups (delefilcon A and narafilcon A) allotted in a consecutive series.
Adverse events
The study observation period was defined as the date from which the patient started receiving care at the study site until the last data point was measured and was between May 1, 2019, and February 29, 2020. To ensure uniform data collection, assessment, and compliance with GCP, onsite training was conducted. The patient data records were selected based on the study inclusion and exclusion criteria and the patients receiving care between May 1, 2019, and February 29, 2020, were included in the study. To minimize bias, the eligible patients were enrolled in one of the two study groups (delefilcon A and narafilcon A) allotted in a consecutive series.
Outcome measures
The background data included age, gender, power (diopter), Schirmer's test (mm), central corneal thickness (CCT; um), ophthalmic solution use, and the following data elements measured on the bare eye, namely TALB (%), NIBUT (seconds) by the tear interferometer DR-1 (Kowa, Tokyo, Japan), and video-corneal topographer Keratograph 5M (Oculus, Wetzlar, Germany), TMH (mm), subjective dryness estimated by the visual analog scale (VAS; minimum 0 and maximum 100), and ocular HOA. The post-baseline data were categorized as visit-1 (v1) and visit-2 (v2) for each patient based on the chronology of availability. For data based on the qualification tests, bare eye measurements, the time that SCLs were worn to the hospital, removed, and washed-out was set as 30 minutes. Data were collected for clinical v1 after tests and observation parameters were measured post-SCL wearing for 15 minutes.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Kawasaki Medical School
Management information
Registered date
| 2021 | Year | 11 | Month | 11 | Day |
Last modified on
| 2021 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041276
