Evaluation of an Investigational Multifocal Lens
2018년 6월 18일 업데이트: Johnson & Johnson Vision Care, Inc.
The purpose of this study is to test the performance of an investigational multifocal test soft contact lens.
연구 개요
연구 유형
중재적
등록 (실제)
371
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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Alabama
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Montgomery, Alabama, 미국, 36109
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California
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Mission Viejo, California, 미국, 92691
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Florida
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Jacksonville, Florida, 미국, 32205
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Jacksonville, Florida, 미국, 32250
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Orange Park, Florida, 미국, 32065
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Saint Augustine, Florida, 미국, 32092
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Tallahassee, Florida, 미국, 32308
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Tampa, Florida, 미국, 33625
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Winter Park, Florida, 미국, 32792
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Georgia
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Roswell, Georgia, 미국, 30076
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Kansas
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Pittsburg, Kansas, 미국, 66762
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Michigan
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East Lansing, Michigan, 미국, 48823
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New York
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Vestal, New York, 미국, 13850
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North Carolina
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Denver, North Carolina, 미국, 28037
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Ohio
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Powell, Ohio, 미국, 43065
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Springfield, Ohio, 미국, 45503
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Rhode Island
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Warwick, Rhode Island, 미국, 02888
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Tennessee
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Memphis, Tennessee, 미국, 38119
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Texas
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Tyler, Texas, 미국, 75701
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Virginia
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Salem, Virginia, 미국, 24153
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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
40년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- The subjects were required to have read, understand, and signed the Statement of Informed Consent and receive a fully executed copy of the form.
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Between 40 and 70 years of age.
- Subjects must own a wearable pair of spectacles, if required for their distance vision.
- Be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month of more duration)
- Already be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire"*
- The subject's vertex corrected spherical equivalent distance refraction was required to be in the range +3.50 to -5.75 in each eye.
- Refractive cylinder ≤ -0.75 D in each eye.
- ADD power in the range +0.75 D to +2.50 D in each eye.
- Best corrected visual acuity of 20/20-3 or better in each eye.
Exclusion Criteria:
- Currently pregnant or lactating (subjects who became pregnant during the study were discontinued).
- Any ocular or systemic allergies that may have contraindicated contact lens wear.
- Any ocular or systemic disease, autoimmune disease, or use of medication, that may have contraindicated contact lens wear.
- Any ocular abnormality that may have interfered with contact lens wear.
- Use of any ocular medication, with the exception of rewetting drops.
- Any previous intraocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
- History of herpetic keratitis.
- History of binocular vision abnormality or strabismus.
- Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV).
- History of diabetes.
- Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
- Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear.
- Any ocular infection or inflammation.
- Any corneal distortion or irregular cornea.
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: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: lotrafilcon B / etafilcon A
Subject randomized to this sequence will first be dispensed the lotrafilcon B contact lens and then the etafilcon A contact lens.
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Soft contact lens to be worn as daily wear, monthly replacement modality.
다른 이름들:
Soft contact lens to be worn as daily wear, daily disposable modality.
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실험적: etafilcon A / lotrafilcon B
Subject randomized to this sequence will first be dispensed the etafilcon A contact lens and then the lotrafilcon B contact lens.
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Soft contact lens to be worn as daily wear, monthly replacement modality.
다른 이름들:
Soft contact lens to be worn as daily wear, daily disposable modality.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Overall Quality of Vision Using the Contact Lens User Experience (CLUE) TM Questionnaire
기간: 8 -12 days post wear
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CLUE Overall Quality of Vision is assessed using the Contact Lens User Experience (CLUE)TM questionnaire.
CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65.
Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.
97% of the scores fall within 0 and 120 (mean +/-3XSD).
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8 -12 days post wear
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Distance Binocular Visual Acuity (LogMAR)
기간: 8- 12 Days post wear
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Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast.
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8- 12 Days post wear
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Intermediate Binocular Visual Acuity (LogMAR)
기간: 8-12 days post wear
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Intermediate time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.
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8-12 days post wear
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Near Binocular Visual Acuity (LogMAR)
기간: 8-12 days post wear
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Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.
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8-12 days post wear
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Corneal Staining
기간: 8 - 12 Days post wear
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Corneal staining is evaluated using Sodium Fluorescein strips.
The Fluorescien strip was lightly placed on the subject's inferior palpebral conjunctiva.
The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.),
Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.).
The data was dichotomized into two group subjects with grade 3 or higher staining, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
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8 - 12 Days post wear
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Bulbar Conjunctival Injection
기간: 8- 12 Days post wear
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The bulbar is the scelra.
Bulbar Conjunctival Injection was assessed using an Efron Grading scale by 1 unit increments.
Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe.
The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
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8- 12 Days post wear
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Limbal Conjunctival Injection
기간: 8- 12 Days post wear
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The Limbus is the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera.
Limbal Conjunctival Injection was assesed using the Efron grading scale in 1 unit increments.
Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe.
The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
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8- 12 Days post wear
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Contact Lens Fitting
기간: 8- 12 Days post wear
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Contact Lens fitting is reported as a binary response.
Yes- acceptable lens fit, No- unacceptable lens fit.
The percentage of subject eyes with acceptable fit is reported.
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8- 12 Days post wear
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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
2014년 8월 1일
기본 완료 (실제)
2014년 11월 1일
연구 완료 (실제)
2014년 11월 1일
연구 등록 날짜
최초 제출
2014년 8월 20일
QC 기준을 충족하는 최초 제출
2014년 8월 20일
처음 게시됨 (추정)
2014년 8월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 6월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 6월 18일
마지막으로 확인됨
2016년 7월 1일
추가 정보
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