Dispensing Study for the Phenacite Project
2020년 10월 30일 업데이트: 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.
연구 개요
상세 설명
Evaluate the objective and patient-reported visual acceptability of the Phenacite contact lens.
연구 유형
중재적
등록 (실제)
25
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Indiana
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Bloomington, Indiana, 미국, 47405
- Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Phenacite
Subjects will be randomized to wear the Phenacite contact lenses binocularly.
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Subjects will be randomized to wear the Phenacite contact lenses binocularly.
Subjects will be randomized to wear the comfilcon A contact lenses binocularly.
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활성 비교기: comfilcon A
Subjects will be randomized to wear the comfilcon A contact lenses binocularly.
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Subjects will be randomized to wear the Phenacite contact lenses binocularly.
Subjects will be randomized to wear the comfilcon A contact lenses binocularly.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Subjective Ratings of Lens Comfort
기간: Baseline (after 15 minutes of lens dispense)
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Subjective ratings of lens comfort.
Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt)
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Baseline (after 15 minutes of lens dispense)
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Subjective Ratings of Lens Comfort
기간: 2 Weeks
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Subjective ratings of lens comfort.
Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt)
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2 Weeks
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Over Refraction for Optimized Distance Acuity
기간: 2 weeks
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Over Refraction for optimized distance acuity measured using logMAR
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2 weeks
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Binocular Distance Visual Acuity - High Illumination High Contrast
기간: Baseline (after 5 minutes of lens dispense)
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Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR
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Baseline (after 5 minutes of lens dispense)
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Binocular Distance Visual Acuity - High Illumination High Contrast
기간: 2 weeks
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Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR
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2 weeks
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Binocular Distance Visual Acuity - Low Illumination High Contrast
기간: Baseline (after 5 minutes of lens dispense)
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Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR
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Baseline (after 5 minutes of lens dispense)
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Binocular Distance Visual Acuity - Low Illumination High Contrast
기간: 2 weeks
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Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR
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2 weeks
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Binocular Near Visual Acuity - High Illumination High Contrast
기간: Baseline (after 5 minutes of lens dispense)
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Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR
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Baseline (after 5 minutes of lens dispense)
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Binocular Near Visual Acuity - High Illumination High Contrast
기간: 2 weeks
|
Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR
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2 weeks
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Binocular Near Visual Acuity - Low Illumination High Contrast
기간: Baseline (after 5 minutes of lens dispense)
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Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR
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Baseline (after 5 minutes of lens dispense)
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Binocular Near Visual Acuity - Low Illumination High Contrast
기간: 2 weeks
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Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR
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2 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Lens Fit - Post Blink Movement
기간: Baseline (after 15 minutes of lens dispense)
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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
기간: 2 weeks
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Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)
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2 weeks
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Push - Up Test for Lens Tightness
기간: 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
기간: 2 weeks
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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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2 weeks
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Lens Mobility Rating
기간: Baseline (after 15 minutes of lens dispense)
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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)
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Lens Mobility Rating
기간: 2 weeks
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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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2 weeks
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Overall Lens Fit Acceptance
기간: Baseline (after 15 minutes of lens dispense)
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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
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Baseline (after 15 minutes of lens dispense)
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Overall Lens Fit Acceptance
기간: 2 weeks
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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
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2 weeks
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Subjective Ratings for Vision Quality - Distance Vision
기간: Baseline (after 15 minutes of lens dispense)
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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
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Baseline (after 15 minutes of lens dispense)
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Subjective Ratings for Vision Quality - Distance Vision
기간: 2 weeks
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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
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2 weeks
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Subjective Ratings for Vision Quality - Near Vision
기간: Baseline (after 15 minutes of lens dispense)
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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
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Baseline (after 15 minutes of lens dispense)
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Subjective Ratings for Vision Quality - Near Vision
기간: 2 weeks
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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
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2 weeks
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Subjective Ratings for Vision Quality - Computer Vision
기간: Baseline (after 15 minutes of lens dispense)
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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
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Baseline (after 15 minutes of lens dispense)
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Subjective Ratings for Vision Quality - Computer Vision
기간: 2 weeks
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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
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2 weeks
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Subjective Ratings for Vision Quality - Overall Vision
기간: Baseline (after 15 minutes of lens dispense)
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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
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Baseline (after 15 minutes of lens dispense)
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Subjective Ratings for Vision Quality - Overall Vision
기간: 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
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2 weeks
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Corneal Staining Extent
기간: 2 weeks
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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
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2 weeks
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Conjunctival Staining
기간: 2 weeks
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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
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2 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Pete Kollbaun, OD PhD, CORL Indiana University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2015년 4월 1일
기본 완료 (실제)
2015년 7월 1일
연구 완료 (실제)
2015년 7월 1일
연구 등록 날짜
최초 제출
2015년 5월 1일
QC 기준을 충족하는 최초 제출
2015년 5월 1일
처음 게시됨 (추정)
2015년 5월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 11월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 10월 30일
마지막으로 확인됨
2020년 10월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .