Dispensing Study for the Phenacite Project
2020年10月30日 更新者：CooperVision, Inc.
Dispensing Study for the Phenacite Project.
The investigational test lens was not the final optical design and the study was not used for design validation.
調査の概要
詳細な説明
Evaluate the objective and patient-reported visual acceptability of the Phenacite contact lens.
研究の種類
介入
入学 (実際)
25
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
-
-
Indiana
-
Bloomington、Indiana、アメリカ、47405
- Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
-
-
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～35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:
- Oculo-visual examination in the last two years
- Between 18 and 35 years of age and has full legal capacity to volunteer
- Has read and understood the informed consent letter
- Is willing and able to follow instructions and maintain the appointment schedule
- Is correctable to a visual acuity of 20/25 or better (in each eye) with their habitual correction or 20/20 best corrected
- Currently wears, or has previously successfully worn, soft contact lenses between -1.00D and -4.00D
- Spherical Contact Lens Rx between -1.00 and -4.00 and spectacle cylinder ≤-0.75
- Has not worn lenses for at least 12 hours before the initial visit
- Has a subjective response at baseline, which indicates suitability for this study
- Currently spends a minimum of 4 hours a day; 5 days a week on digital devices and can replicate this time during the study period
- Is willing and able to wear the study contact lenses a minimum of 10 hours per day; 5 days a week.
Exclusion Criteria:
- Has never worn contact lenses before
- Any systemic disease affecting ocular health
- Is using any systemic or topical medications that will affect ocular health
- Has known sensitivity to the diagnostic pharmaceuticals or study products used in this study.
- Has any ocular pathology or anomaly that would affect the wearing of the lenses
- Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye
- Is aphakic
- Has anisometropia of >1.00
- Has undergone corneal refractive surgery
- Has strabismus
- Has any ocular amblyopia >= 1line of HC Visual Acuity
- Is participating in any other type of eye related clinical or research study
- Has participated in study CV-14-32.
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Phenacite
Subjects will be randomized to wear the Phenacite contact lenses binocularly.
|
Subjects will be randomized to wear the Phenacite contact lenses binocularly.
Subjects will be randomized to wear the comfilcon A contact lenses binocularly.
|
|
アクティブコンパレータ：comfilcon A
Subjects will be randomized to wear the comfilcon A contact lenses binocularly.
|
Subjects will be randomized to wear the Phenacite contact lenses binocularly.
Subjects will be randomized to wear the comfilcon A contact lenses binocularly.
|
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 |
|---|---|---|
|
Subjective Ratings of Lens Comfort
時間枠：Baseline (after 15 minutes of lens dispense)
|
Subjective ratings of lens comfort.
Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt)
|
Baseline (after 15 minutes of lens dispense)
|
|
Subjective Ratings of Lens Comfort
時間枠：2 Weeks
|
Subjective ratings of lens comfort.
Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt)
|
2 Weeks
|
|
Over Refraction for Optimized Distance Acuity
時間枠：2 weeks
|
Over Refraction for optimized distance acuity measured using logMAR
|
2 weeks
|
|
Binocular Distance Visual Acuity - High Illumination High Contrast
時間枠：Baseline (after 5 minutes of lens dispense)
|
Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR
|
Baseline (after 5 minutes of lens dispense)
|
|
Binocular Distance Visual Acuity - High Illumination High Contrast
時間枠：2 weeks
|
Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR
|
2 weeks
|
|
Binocular Distance Visual Acuity - Low Illumination High Contrast
時間枠：Baseline (after 5 minutes of lens dispense)
|
Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR
|
Baseline (after 5 minutes of lens dispense)
|
|
Binocular Distance Visual Acuity - Low Illumination High Contrast
時間枠：2 weeks
|
Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR
|
2 weeks
|
|
Binocular Near Visual Acuity - High Illumination High Contrast
時間枠：Baseline (after 5 minutes of lens dispense)
|
Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR
|
Baseline (after 5 minutes of lens dispense)
|
|
Binocular Near Visual Acuity - High Illumination High Contrast
時間枠：2 weeks
|
Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR
|
2 weeks
|
|
Binocular Near Visual Acuity - Low Illumination High Contrast
時間枠：Baseline (after 5 minutes of lens dispense)
|
Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR
|
Baseline (after 5 minutes of lens dispense)
|
|
Binocular Near Visual Acuity - Low Illumination High Contrast
時間枠：2 weeks
|
Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR
|
2 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Lens Fit - Post Blink Movement
時間枠：Baseline (after 15 minutes of lens dispense)
|
Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)
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Baseline (after 15 minutes of lens dispense)
|
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Lens Fit - Post Blink Movement
時間枠：2 weeks
|
Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)
|
2 weeks
|
|
Push - Up Test for Lens Tightness
時間枠：Baseline (after 15 minutes of lens dispense)
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Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement
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Baseline (after 15 minutes of lens dispense)
|
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Push - Up Test for Lens Tightness
時間枠：2 weeks
|
Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement
|
2 weeks
|
|
Lens Mobility Rating
時間枠：Baseline (after 15 minutes of lens dispense)
|
Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (>1mm) on versions in all directions in 0.25 steps
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Baseline (after 15 minutes of lens dispense)
|
|
Lens Mobility Rating
時間枠：2 weeks
|
Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (>1mm) on versions in all directions in 0.25 steps
|
2 weeks
|
|
Overall Lens Fit Acceptance
時間枠：Baseline (after 15 minutes of lens dispense)
|
Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps
|
Baseline (after 15 minutes of lens dispense)
|
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Overall Lens Fit Acceptance
時間枠：2 weeks
|
Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps
|
2 weeks
|
|
Subjective Ratings for Vision Quality - Distance Vision
時間枠：Baseline (after 15 minutes of lens dispense)
|
Patient subjective scoring using 0-100 continuous scale for Distance Quality of Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
|
Baseline (after 15 minutes of lens dispense)
|
|
Subjective Ratings for Vision Quality - Distance Vision
時間枠：2 weeks
|
Patient subjective scoring using 0-100 continuous scale for Distance Quality of Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
|
2 weeks
|
|
Subjective Ratings for Vision Quality - Near Vision
時間枠：Baseline (after 15 minutes of lens dispense)
|
Patient subjective scoring using 0-100 continuous scale for Near Quality of Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
|
Baseline (after 15 minutes of lens dispense)
|
|
Subjective Ratings for Vision Quality - Near Vision
時間枠：2 weeks
|
Patient subjective scoring using 0-100 continuous scale for Near Quality of Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
|
2 weeks
|
|
Subjective Ratings for Vision Quality - Computer Vision
時間枠：Baseline (after 15 minutes of lens dispense)
|
Patient subjective scoring using 0-100 continuous scale for Computer Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
|
Baseline (after 15 minutes of lens dispense)
|
|
Subjective Ratings for Vision Quality - Computer Vision
時間枠：2 weeks
|
Patient subjective scoring using 0-100 continuous scale for Computer Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
|
2 weeks
|
|
Subjective Ratings for Vision Quality - Overall Vision
時間枠：Baseline (after 15 minutes of lens dispense)
|
Patient subjective scoring using 0-100 continuous scale for Overall Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
|
Baseline (after 15 minutes of lens dispense)
|
|
Subjective Ratings for Vision Quality - Overall Vision
時間枠：2 weeks
|
Patient subjective scoring using 0-100 continuous scale for Overall Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
|
2 weeks
|
|
Corneal Staining Extent
時間枠：2 weeks
|
Corneal staining extent was assessed on a scale of 0-4 (0-No Staining, 1 - 1-15% of area, 2- 16-30% of area, 3- 31-45% of area, 4- >45% of area
|
2 weeks
|
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Conjunctival Staining
時間枠：2 weeks
|
Conjunctival staining was assessed on a scale of 0-4, 0.50 steps (0-None, 1 - Minimal diffuse punctuate, 2- Coalescent Punctuate, 3- confluent, 4- Deep confluent
|
2 weeks
|
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：Pete Kollbaun, OD PhD、CORL Indiana University
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
2015年4月1日
一次修了 (実際)
2015年7月1日
研究の完了 (実際)
2015年7月1日
試験登録日
最初に提出
2015年5月1日
QC基準を満たした最初の提出物
2015年5月1日
最初の投稿 (見積もり)
2015年5月6日
学習記録の更新
投稿された最後の更新 (実際)
2020年11月18日
QC基準を満たした最後の更新が送信されました
2020年10月30日
最終確認日
2020年10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。