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UMIN ID:

試験進捗状況 主たる結果の公表済み/Main results already published
UMIN試験ID UMIN000046034
受付番号 R000041276
科学的試験名 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
一般公開日(本登録希望日) 2021/11/11
最終更新日 2021/11/11

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title 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 Superiority of tear flow dynamics in DAILIES TOTAL1 with three layered structure
一般向け試験名略称/Acronym 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 Superiority of tear flow dynamics in DAILIES TOTAL1 with three layered structure
科学的試験名/Scientific Title 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 Superiority of tear flow dynamics in DAILIES TOTAL1 with three layered structure
科学的試験名略称/Scientific Title:Acronym 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 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/Condition
対象疾患名/Condition コンタクトレンズユーザー 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/Objectives
目的1/Narrative objectives1 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 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

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

評価/Assessment
主要アウトカム評価項目/Primary outcomes 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
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


基本事項/Base
試験の種類/Study type 観察/Observational

試験デザイン/Study design
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

介入/Intervention
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

介入2/Interventions/Control_2

介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
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 活動性の眼表面疾患を有さない Without active ocular surface disease
除外基準/Key exclusion criteria 活動性の眼表面疾患を伴う With active ocular surface disease
目標参加者数/Target sample size 50

責任研究者/Research contact person
責任研究者/Name of lead principal investigator
久貴
ミドルネーム
藤本
Hisataka
ミドルネーム
Fujimoto
所属組織/Organization 川崎医科大学 Kawasaki Medical School
所属部署/Division name 眼科学 Department of Ophthalmology
郵便番号/Zip code 701-0192
住所/Address 倉敷市 松島 577 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/Public contact
試験問い合わせ窓口担当者/Name of contact person
久貴
ミドルネーム
藤本
Hisataka
ミドルネーム
Fujimoto
組織名/Organization 川崎医科大学 Kawasaki Medical School
部署名/Division name 眼科学 Department of Ophthalmology
郵便番号/Zip code 701-0192
住所/Address 倉敷市 松島 577 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

実施責任組織/Sponsor
機関名/Institute 川崎医科大学 Kawasaki Medical School
機関名/Institute
(機関選択不可の場合)
Kawasaki Medical School
部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 Alcon
機関名/Organization
(機関選択不可の場合)
日本アルコン
組織名/Division
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

その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s) 川崎医科大学

IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization 川崎医科大学 Kawasaki Medical School
住所/Address 倉敷市 松島 577 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
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

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2021 11 11

関連情報/Related information
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/Result
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 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: 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 11 11
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

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 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. 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 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. 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 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. 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 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%. 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

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


試験進捗状況/Progress
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 02 16
倫理委員会による承認日/Date of IRB
2019 02 16
登録・組入れ開始(予定)日/Anticipated trial start date
2019 05 01
フォロー終了(予定)日/Last follow-up date
2020 02 29
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/Other
その他関連情報/Other related information Kawasaki Medical School Kawasaki Medical School

管理情報/Management information
登録日時/Registered date
2021 11 11
最終更新日/Last modified on
2021 11 11


閲覧ページへのリンク/Link to view the page
URL(日本語) https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000041276
URL(英語) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041276

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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