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Design Validation of Senofilcon A With New UV-blocking Additive

2019년 11월 15일 업데이트: Johnson & Johnson Vision Care, Inc.
This is a 2-visit, multi-site, partially subject-masked, 2-arm parallel, controlled, randomized and dispensing trial. Subjects will be randomized to one of two study lenses for the entire duration of the study. The study lenses will be worn for a period of 2 weeks each in a bilateral fashion.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

253

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • California
      • Cupertino, California, 미국, 95014
        • James T. Fujimoto, OD
    • Florida
      • Maitland, Florida, 미국, 32751
        • Maitland Vision Center
      • Tallahassee, Florida, 미국, 32308
        • Tallahassee Eye Center
    • Illinois
      • Bloomington, Illinois, 미국, 61701
        • Eyecare Associates LLP
    • Kansas
      • Pittsburg, Kansas, 미국, 66762
        • Kannarr Eye Care
    • Ohio
      • Granville, Ohio, 미국, 43023
        • Procare Vision Centers
      • Westerville, Ohio, 미국, 43081
        • Professional Vision Care, Inc
    • Tennessee
      • Memphis, Tennessee, 미국, 38111
        • Bradley Hines, OD
    • Texas
      • Tyler, Texas, 미국, 75703
        • Frazier Vision, Inc
    • Wisconsin
      • New Berlin, Wisconsin, 미국, 53151
        • Ziegler Leffingwell Eyecare

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

예

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Potential subjects must satisfy all of the following criteria to be enrolled in the study:

    1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
    2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
    3. Between 18 and 49 (inclusive) years of age at the time of informed consent.
    4. Eligible presbyopes will be those that wear full distance contact lenses in both eyes, then wear reading glasses over them when needed for near vision.
    5. The subject is a current spherical soft contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week wear time over the last 30 days by self-report.
    6. Subjects must be able and willing to wear the study lenses at least 6 hours a day, a minimum of 5 days per week.
    7. Subjects must own a wearable pair of distance spectacles.
    8. The subject's vertex-corrected spherical equivalent distance refraction must be in the range of -1.00 to -6.00 D (inclusive) in each eye.
    9. The subject's refractive cylinder must be 0.00 to -1.00 D (inclusive) in each eye.

    10. The subject must have a spherocylindrical best corrected distance Snellen visual acuity of 20/25+3 or better in each eye.

      Exclusion Criteria:

  • Potential subjects who meet any of the following criteria will be excluded from participating in the study:

    1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
    2. Any active or ongoing systemic disease (e.g., Sjögren's Syndrome), infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis).
    3. Subjects taking suspect oral medications for less than one year.
    4. Any prescribed or over the counter (OTC) ocular medication.
    5. Any known hypersensitivity or allergic reaction to Optifree® PureMoist® multi-purpose care solution or Eye-Cept® rewetting drop solution.
    6. Toric, extended wear, monovision or multi-focal contact lens correction.
    7. Any previous or planned (during the course of the study) ocular surgery (e.g., PRK, LASIK, etc.).
    8. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
    9. Participation in clinical trials involving the Test lens within 3 months prior to study enrollment.
    10. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
    11. Binocular vision abnormality or strabismus by self-report or prior medical history.
    12. History of recurrent corneal erosions, herpetic keratitis, or pathological dry eye.
    13. Any active ocular allergies, infections or other ocular abnormalities (entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma) that the investigator determines may interfere with the outcomes of this study or otherwise contraindicate participation in the study.
    14. Any Grade 2 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA Slit Lamp Classification Scale.
    15. Any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar) within the past 3 years of otherwise successful contact lens wear.

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: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: senofilcon A TEST Lens
Subjects between 18 to 49 years of age that are habitual wearers of spherical soft contact lenses will be randomized into the TEST Lens for the duration of the clinical study.
장치: senofilcon A TEST Lens
JJVC Investigational Contact Lens
활성 비교기: senofilcon A CONTROL Lens
Subjects between 18 to 49 years of age that are habitual wearers of spherical soft contact lenses will be randomized into the CONTROL Lens for the duration of the clinical study.
장치: senofilcon A CONTROL Lens
Acuvue Oasys

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Overall Comfort Score
기간: 2-Week Follow-up Evlauation
Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patientexperience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
2-Week Follow-up Evlauation
Vision Satisfaction in Bright Lighting
기간: 2-Week Follow-up Evaluation
Vision satisfaction in bright light was assessed using the individual item" I was satisfied with the quality of my vision in bright lighting" from the CLUE™ questionnaire. This item used the response scale, 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. CLUE is the Contact Lens User Experience™ questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The Proportion of responses in each category were reported for each lens type.
2-Week Follow-up Evaluation
Distance Visual Acuity
기간: 2-Week Follow-up Evlauation
Distance visual acuity was assessed by eye using LogMAR visual acuity at 4 meters using an ETDRS chart under high illumination high contrast conditions (room illumination > 400 lux and chart luminance 120-200 cd/m2) at the 2-week follow-up for each subject eye. Lower values of logMAR indicate better vision, where a score of 0.0 equates to 20/20 snellen vision. The average visual acuity for each lens was reported.
2-Week Follow-up Evlauation
Contact Lens Fitting Acceptance Rate
기간: Up to 2-Week Follow-up

Acceptable lens fit will be assessed at all study visits (scheduled and unscheduled) for each subject eye. Fit acceptance rate will be based on the lens fit acceptance of eyes wearing the Test lens only. Fit acceptance is a binary response where Y=1 if lens fit is acceptable and Y=0 otherwise. Unacceptable is defined as unacceptable if any one of the following criteria:

  • limbal exposure at primary gaze or with extreme eye movement;
  • edge lift;
  • excessive movement in primary up gaze;
  • insufficient movement in all three of the following conditions: primary gaze, up gaze, and push up test.

Eyes with multiple unacceptable fitting events will be counted only once. Fit rates of the Control lens will also be collected but are not a primary endpoint.
Up to 2-Week Follow-up
Number of Grade 3 or Higher Slit Lamp Findings
기간: Up to 2-Week Follow-up Evlauation
Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). Slit Lamp Findings will be assessed for each subject eye at all study visits (schedule and unscheduled). SLF is a binary response where Y=1 for at least one Grade 3 or 4 slit lamp finding. The percentage of eyes with Grade 3 or higher slit lamp findings will be analyzed and will include corneal infiltrates. Eyes with multiple events will be counted only once. The number of eyes with SLF with grade 3 or higher by lens was reported.
Up to 2-Week Follow-up Evlauation

2차 결과 측정

결과 측정
측정값 설명
기간
Overall Handling Score
기간: 2-Week Follow-up Evlauation
Overall handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patientexperience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
2-Week Follow-up Evlauation
Overall Quality of Vision Score
기간: 2-Week Follow-up Evlauation
Overall quality of vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patientexperience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
2-Week Follow-up Evlauation

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Johnson & Johnson Vision Care, Inc.

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 (실제)

2018년 10월 1일

기본 완료 (실제)

2018년 11월 1일

연구 완료 (실제)

2018년 11월 1일

연구 등록 날짜

최초 제출

2018년 10월 12일

QC 기준을 충족하는 최초 제출

2018년 10월 12일

처음 게시됨 (실제)

2018년 10월 16일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 12월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 11월 15일

마지막으로 확인됨

2019년 11월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • CR-6305

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

예

미국에서 제조되어 미국에서 수출되는 제품

예

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. .

senofilcon A TEST Lens에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Tunisia

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다