UMIN-CTR 臨床試験登録情報の閲覧

一般向け試験名/Public title

日本語
ウォーターグラディエント構造を持つデイリーズトータルワンの、涙液動態における優位性

英語
Superiority of tear flow dynamics in DAILIES TOTAL1 with three layered structure

一般向け試験名略称/Acronym

日本語
ウォーターグラディエント構造を持つデイリーズトータルワンの、涙液動態における優位性

英語
Superiority of tear flow dynamics in DAILIES TOTAL1 with three layered structure

科学的試験名/Scientific Title

日本語
ウォーターグラディエント構造を持つデイリーズトータルワンの、涙液動態における優位性

英語
Superiority of tear flow dynamics in DAILIES TOTAL1 with three layered structure

科学的試験名略称/Scientific Title:Acronym

日本語
ウォーターグラディエント構造を持つデイリーズトータルワンの、涙液動態における優位性

英語
Superiority of tear flow dynamics in DAILIES TOTAL1 with three layered structure

試験実施地域/Region

日本/Japan

対象疾患名/Condition

日本語
コンタクトレンズユーザー

英語
SCL user

疾患区分1/Classification by specialty

眼科学/Ophthalmology

疾患区分2/Classification by malignancy

悪性腫瘍以外/Others

ゲノム情報の取扱い/Genomic information

いいえ/NO

目的1/Narrative objectives1

日本語
デイリーズトータルワンを処方された被験者において、涙液動態の優位性を検討する

英語
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.

目的2/Basic objectives2

有効性/Efficacy

目的2 -その他詳細/Basic objectives -Others

日本語

英語

試験の性質1/Trial characteristics_1

試験の性質2/Trial characteristics_2

試験のフェーズ/Developmental phase

主要アウトカム評価項目/Primary outcomes

日本語
NIBUT（裸眼およびCL装用15分以上経過後の）
　涙液層動態（ブレイクアップパターン）
　眼表面涙液厚
　ソフトコンタクトレンズ厚
　涙液メニスカス高

英語
NIBUT
Tear Break up pattern
Tear film thickness
SCL thickness
Tear meniscus height

副次アウトカム評価項目/Key secondary outcomes

日本語

英語

試験の種類/Study type

観察/Observational

基本デザイン/Basic design

ランダム化/Randomization

ランダム化の単位/Randomization unit

ブラインド化/Blinding

コントロール/Control

層別化/Stratification

動的割付/Dynamic allocation

試験実施施設の考慮/Institution consideration

ブロック化/Blocking

割付コードを知る方法/Concealment

群数/No. of arms

介入の目的/Purpose of intervention

介入の種類/Type of intervention

介入1/Interventions/Control_1

日本語

英語

介入2/Interventions/Control_2

日本語

英語

介入3/Interventions/Control_3

日本語

英語

介入4/Interventions/Control_4

日本語

英語

介入5/Interventions/Control_5

日本語

英語

介入6/Interventions/Control_6

日本語

英語

介入7/Interventions/Control_7

日本語

英語

介入8/Interventions/Control_8

日本語

英語

介入9/Interventions/Control_9

日本語

英語

介入10/Interventions/Control_10

日本語

英語

年齢（下限）/Age-lower limit

20

歳/years-old

以上/<=

年齢（上限）/Age-upper limit

110

歳/years-old

以下/>=

性別/Gender

男女両方/Male and Female

選択基準/Key inclusion criteria

日本語
活動性の眼表面疾患を有さない

英語
Without active ocular surface disease

除外基準/Key exclusion criteria

日本語
活動性の眼表面疾患を伴う

英語
With active ocular surface disease

目標参加者数/Target sample size

50

責任研究者/Name of lead principal investigator

日本語

名	久貴
ミドルネーム
姓	藤本

英語

名	Hisataka
ミドルネーム
姓	Fujimoto

所属組織/Organization

日本語
川崎医科大学

英語
Kawasaki Medical School

所属部署/Division name

日本語
眼科学

英語
Department of Ophthalmology

郵便番号/Zip code

701-0192

住所/Address

日本語
倉敷市　松島　５７７

英語
Matsushima 577, Kurashiki

電話/TEL

0864621111

Email/Email

fujimoto-h@med.kawasaki-m.ac.jp

試験問い合わせ窓口担当者/Name of contact person

日本語

名	久貴
ミドルネーム
姓	藤本

英語

名	Hisataka
ミドルネーム
姓	Fujimoto

組織名/Organization

日本語
川崎医科大学

英語
Kawasaki Medical School

部署名/Division name

日本語
眼科学

英語
Department of Ophthalmology

郵便番号/Zip code

701-0192

住所/Address

日本語
倉敷市　松島　５７７

英語
Matsushima 577, Kurashiki

電話/TEL

0864621111

試験のホームページURL/Homepage URL

Email/Email

fujimohis@yahoo.co.jp

機関名/Institute

日本語
川崎医科大学

英語
Kawasaki Medical School

機関名/Institute
（機関選択不可の場合）

日本語
Kawasaki Medical School

部署名/Department

日本語

個人名/Personal name

日本語

英語

機関名/Organization

日本語
その他

英語
Alcon

機関名/Organization
（機関選択不可の場合）

日本語
日本アルコン

組織名/Division

日本語

組織の区分/Category of Funding Organization

営利企業/Profit organization

研究費拠出国/Nationality of Funding Organization

日本語
日本

英語

共同実施組織/Co-sponsor

日本語

英語

その他の研究費提供組織/Name of secondary funder(s)

日本語
川崎医科大学

英語

組織名/Organization

日本語
川崎医科大学

英語
Kawasaki Medical School

住所/Address

日本語
倉敷市　松島　５７７

英語
Matsushima 577, Kurashiki

電話/Tel

0864621111

Email/Email

fujimohis@yahoo.co.jp

他機関から発行された試験ID/Secondary IDs

いいえ/NO

試験ID1/Study ID_1

ID発行機関1/Org. issuing International ID_1

日本語

英語

試験ID2/Study ID_2

ID発行機関2/Org. issuing International ID_2

日本語

英語

治験届/IND to MHLW

試験実施施設名称/Institutions

一般公開日（本登録希望日）/Date of disclosure of the study information

2021

年

11

月

11

日

プロトコル掲載URL/URL releasing protocol

https://tvst.arvojournals.org/article.aspx?articleid=2777865

試験結果の公開状況/Publication of results

中間解析等の途中公開/Partially published

結果掲載URL/URL related to results and publications

https://tvst.arvojournals.org/article.aspx?articleid=2777865

組み入れ参加者数/Number of participants that the trial has enrolled

50

主な結果/Results

日本語
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).

英語
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).

主な結果入力日/Results date posted

2021

年

11

月

11

日

結果掲載遅延/Results Delayed

結果遅延理由/Results Delay Reason

日本語

英語

最初の試験結果の出版日/Date of the first journal publication of results

参加者背景/Baseline Characteristics

日本語
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.

英語
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.

参加者の流れ/Participant flow

日本語
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.

英語
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.

有害事象/Adverse events

日本語
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.

英語
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.

評価項目/Outcome measures

日本語
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-1α (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. For clinical v2, data from tests and observation parameters measured after wearing SCLs for 5 hours, after 30 ± 5 days of wearing SCLs following v1, were collected. Between v1 and v2, SCLs were used 5 to 12 hours per day, and 5 to 7 days per week. Room temperature and humidity was maintained at 23 to 25°C and 30 to 40%.

英語
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.

個別症例データ共有計画/Plan to share IPD

日本語

英語

個別症例データ共有計画の詳細/IPD sharing Plan description

日本語

英語

試験進捗状況/Recruitment status

主たる結果の公表済み/Main results already published

プロトコル確定日/Date of protocol fixation

2019

年

02

月

16

日

倫理委員会による承認日/Date of IRB

2019

年

02

月

16

日

登録・組入れ開始（予定）日/Anticipated trial start date

2019

年

05

月

01

日

フォロー終了(予定)日/Last follow-up date

2020

年

02

月

29

日

入力終了(予定)日/Date of closure to data entry

データ固定（予定）日/Date trial data considered complete

解析終了(予定)日/Date analysis concluded

その他関連情報/Other related information

日本語
Kawasaki Medical School

英語
Kawasaki Medical School

登録日時/Registered date

2021

年

11

月

11

日

最終更新日/Last modified on

2021

年

11

月

11

日

閲覧ページへのリンク/Link to view the page

日本語
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000041276

英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041276