Multi-center Clinical Evaluation of PC 1-Day vs 1-Day Acuvue Moist
2020年7月19日 更新者：CooperVision, Inc.
The objective of this study is to compare the clinical performance of ProClear 1-Day versus 1-Day Acuvue Moist each for one week of daily disposable wear.
調査の概要
詳細な説明
The purpose of this cross-over study is to evaluate the clinical performance of the ProClear-1 Day in comparison with 1-Day Acuvue® Moist®.
In particular, the study will focus on lens wearing comfort.
研究の種類
介入
入学 (実際)
43
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
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Arizona
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Phoenix、Arizona、アメリカ、85032
- Phoenix Eye Care, PLLC
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Illinois
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Lake Zurich、Illinois、アメリカ、60047
- Lake Zurich Eye Care
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Ohio
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Athens、Ohio、アメリカ、45701
- Drs. Quinn, Foster & Assoc.
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New Albany、Ohio、アメリカ、43054
- Vision Professionals
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～40年 (大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
A person is eligible for inclusion in the study if he/she:
- Is between 18 and 40 years of age (inclusive)
- Have the use of a mobile phone to send and receive text messages throughout the day for the duration of the study.
- Has had a self-reported visual exam in the last two years
- Is an adapted soft CL (Contact Lens) wearer
- Must be able to wear their lenses at least 6 full days over the 7 days; 14 hours per day, assuming there are no contraindications for doing so
- Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)
- Has less than 0.75D (Diopters) spectacle cylinder in each eye.
- Is correctable to a visual acuity of 20/25 or better in both eyes
- Has clear corneas and no active ocular disease
- Has read, understood and signed the information consent letter.
- Is willing to comply with the wear schedule (at least 40 hrs per week)
- Is willing to comply with the visit schedule
Exclusion Criteria:
A person will be excluded from the study if he/she:
- Has never worn contact lenses before.
- Currently wears rigid gas permeable contact lenses.
- Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
- Has a CL prescription outside the range of - 1.00 to -6.00D
- Has a spectacle cylinder greater than -0.50D of cylinder in either eye.
- Has best corrected spectacle distance vision worse then 20/25 in either eye.
- Has any systemic disease affecting ocular health.
- Is using any systemic or topical medications that will affect ocular health.
- Has any ocular pathology or severe insufficiency of lacrimal secretion
- Has persistent, clinically significant corneal or conjunctival staining
- Has active neovascularization or any central corneal scars.
- Is aphakic.
- Is presbyopic.
- Has undergone corneal refractive surgery.
- Is participating in any other type of eye related clinical or research study.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：omafilcon A
Study participants are randomized to wear omafilcon A lenses.
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コンタクトレンズ
他の名前：
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アクティブコンパレータ：etafilcon A
Study participants are randomized to wear etafilcon A lenses.
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コンタクトレンズ
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Comfort (Subjective Assessment)
時間枠：Baseline
|
Subjective Assessment of comfort on insertion at baseline for each pair using questionnaire and rated on subjective response scale.
(0-10; 0= very uncomfortable, 10=cannot feel)
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Baseline
|
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Comfort (Subjective Assessment)
時間枠：1 Week
|
Subjective Assessment: Insertion Comfort, Comfort During Day, Comfort Prior to Removal, Comfort Overall for each pair using questionnaire and rated on subjective response scale.
(0-10; 0= very uncomfortable, 10=cannot feel)
|
1 Week
|
|
Hydration (Subjective Assessment)
時間枠：Baseline
|
Subjective Assessment of hydration on insertion at baseline for each pair using questionnaire and rated on subjective response scale.
(0-10; 0= very dehydrated, not hydrophilic, very dry, 10=very hydrated, ultra hydrophilic)
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Baseline
|
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Hydration (Subjective Assessment)
時間枠：1 Week
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Subjective Assessment: Initial Hydration, Hydration During Day, Hydration Prior to Removal for each pair using questionnaire and rated on subjective response scale.
(0-10; 0= very dehydrated, not hydrophilic, very dry, 10=very hydrated, ultra hydrophilic)
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1 Week
|
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Vision Quality (Subjective Assessment)
時間枠：Baseline
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Subjective Assessment: Visual quality on insertion at baseline for each pair using questionnaire and rated on subjective response scale (0-10; 0= clear vision, 10=perfectly sharp)
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Baseline
|
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Vision Satisfaction (Subjective Assessment)
時間枠：1 Week
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Subjective Assessment: Vision Satisfaction for each pair using questionnaire and rated on subjective response scale.
(0-10; 0= very unsatisfied, 10=very satisfied)
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1 Week
|
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Dryness (Subjective Assessment)
時間枠：1 Week
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Subjective Assessment: Dryness During Day, Dryness Prior to Removal, Overall Dryness for each pair using questionnaire and rated on subjective response scale.
(0-10; 0= very dry, 10=no dryness)
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1 Week
|
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Handling (Subjective Assessment)
時間枠：1 Week
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Subjective Assessment: Handling on Insertion and Removal, Overall Handling for each pair using questionnaire and rated on subjective response scale.
(0-10; 0= very difficult, 10=very easy)
|
1 Week
|
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Eye Whiteness/Redness (Subjective Assessment)
時間枠：1 Week
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Subjective Assessment: Eye Whiteness/Redness for each pair using questionnaire and rated on subjective response scale.
(0-10; 0= significant redness, 10=totally white)
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1 Week
|
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Overall Sensation of Smoothness (Subjective Assessment)
時間枠：1 Week
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Subjective Assessment: Overall sensation of smoothness at 1 week wear for each pair when asked "How would you rate the overall sensation of smoothness (deposit resistance) of the first study lenses, over the last week of wear?" (Likert 1-5; 1=excellent, 2=good, 3=average, 4=below average, 5=poor)
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1 Week
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Overall Satisfaction for Lens
時間枠：1 Week
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Subjective Assessment: Satisfaction overall at 1 Week wear for each pair when asked "Overall, how satisfied was the subject with the study lenses, during the last week, with regards to: Overall?" (Likert 1-4; 1=completely satisfied, 2=somewhat satisfied, 3=somewhat dissatisfied, 4=completely dissatisfied)
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1 Week
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Donald Siegel, OD、Sun City West Eye Care
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2014年1月1日
一次修了 (実際)
2014年1月1日
研究の完了 (実際)
2014年3月1日
試験登録日
最初に提出
2013年12月27日
QC基準を満たした最初の提出物
2013年12月27日
最初の投稿 (見積もり)
2013年12月31日
学習記録の更新
投稿された最後の更新 (実際)
2020年7月30日
QC基準を満たした最後の更新が送信されました
2020年7月19日
最終確認日
2020年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。