Formula Identification (FID) 114657 in Contact Lens Wearers
2016년 10월 4일 업데이트: Alcon Research
Evaluation of a Lubricant Eye Drop on Tear Lipid Layer Thickness in Contact Lens Wearers
The purpose of this study is to evaluate the thickness of the pre-lens tear lipid layer after 2 hours of lens wear with use of FID 114657 compared to saline control.
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (실제)
234
단계
- 해당 없음
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 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Must sign the informed consent form.
- Stable, tear lipid layer thickness ≤ 75 nm without contact lenses.
- Successfully wearing bi-weekly or monthly replacement soft contact lenses in both eyes for a minimum of 5 days/week during the past 2 months prior to Visit 1.
- Vision correctable to 20/25 Snellen (feet) or better at distance with habitual contact lenses at Visit 1.
- Willing to wear lenses 5 days a week, 8 hours a day for at least 2 days during the study.
- Demonstrate symptoms of contact lens discomfort.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Routinely sleeping in lenses.
- Any active eye inflammation or condition that contraindicates contact lens wear.
- Any systemic diseases that could prevent successful contact lens wear.
- Use of systemic or ocular medications that contraindicate lens wear.
- Fit with only 1 contact lens.
- Unwilling to discontinue the use of cosmetics (such as eyeliner, mascara, or eye shadow) or facial creams on or around the eyelids on Day 1 and Day 14 of the study.
- Women of childbearing potential who are currently pregnant, test positive for pregnancy at Screening visit, breast feeding, or unwilling to use adequate birth control throughout the study.
- Other protocol-defined exclusion criteria may apply.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: FID 114657
FID 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
|
Lubricating eye drop for temporary relief of burning and irritation due to dryness of the eye
Commercially marketed biweekly or monthly replacement soft contact lenses as prescribed by eye care practitioner, brand and power
|
|
활성 비교기: Saline Control
Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
|
Commercially marketed biweekly or monthly replacement soft contact lenses as prescribed by eye care practitioner, brand and power
Saline eye drops (15 ml)
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mean Pre-lens Tear Lipid Layer Thickness After 2 Hours of Lens Wear on Day 1
기간: Day 1, after 2 hours of lens wear
|
The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens).
The anterior-most layer of the pre-lens tear film consists of lipids.
Lipid layer thickness (LLT) is measured with the LipiView® Interferometer.
LLT is measured in interferometric color units (ICUs), where 1 ICU reflects about 1 nanometer (nm) lipid layer thickness.
Higher values of LLT indicate a better lubrication of the ocular surface.
A thicker tear lipid layer helps reduce evaporation and is indicative of a more stable tear film.
The right eye only was used for this measure.
|
Day 1, after 2 hours of lens wear
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mean Comfortable Lens Wear Time (Time Uncomfortable - Time Insertion) at Baseline and Day 14
기간: Baseline (Day 0), Day 14
|
At Baseline and on Day 14, comfort was collected through participant questionnaires regarding average and comfortable wear time.
Participants filled in what time of day (over the past three days) they usually inserted their lenses, removed them, and at what time they usually became uncomfortable, or if they remained comfortable all day.
Comfortable wear time was calculated as Time Uncomfortable minus Time Insertion.
The participant rated both eyes together by providing one single rating.
This outcome measure was prespecified for only FID 114657.
|
Baseline (Day 0), Day 14
|
|
Percentage of Participants That Experienced At Least 1 Unit Increase From Baseline Score to Day 14 for Overall Comfort With Lenses
기간: Baseline (Day 0), Day 14
|
Overall comfort was rated by the participant on a 10-point scale, where 1=Poor and 10=Excellent, at Day 0 for their habitual lenses and at Day 14 for the lenses worn for the study during use of the assigned drop regimen.
A 1-unit increase indicates improvement.
The participant rated both eyes together by providing one single rating.
|
Baseline (Day 0), Day 14
|
|
Mean Change From Baseline in Comfortable Lens Wear Time (Time Uncomfortable - Time Insertion) to Day 14
기간: Baseline (Day 0), Day 14
|
At Baseline and on Day 14, comfort was collected through participant questionnaires regarding average and comfortable wear time.
Participants filled in what time of day (over the past three days) they usually inserted their lenses, removed them, and at what time they usually became uncomfortable, or if they remained comfortable all day.
Comfortable wear time was calculated as Time Uncomfortable minus Time Insertion.
A positive change from Baseline indicates improvement.
The participant rated both eyes together by providing one single rating.
|
Baseline (Day 0), Day 14
|
|
Mean Pre-lens Tear Lipid Layer Thickness After 2 Hours of Lens Wear on Day 14
기간: Day 14, after 2 hours of lens wear
|
The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens).
The anterior-most layer of the pre-lens tear film consists of lipids.
Lipid layer thickness (LLT) is measured with the LipiView® Interferometer.
LLT is measured in interferometric color units (ICUs), where 1 ICU reflects about 1 nanometer (nm) lipid layer thickness.
Higher values of LLT indicate a better lubrication of the ocular surface.
A thicker tear lipid layer helps reduce evaporation and is indicative of a more stable tear film.
The right eye only was used for this measure.
|
Day 14, after 2 hours of lens wear
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 연구 책임자: Clinical Manager, Pharmaceuticals, Global Medical Affairs, Alcon Research
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 11월 1일
기본 완료 (실제)
2015년 7월 1일
연구 완료 (실제)
2015년 7월 1일
연구 등록 날짜
최초 제출
2014년 11월 14일
QC 기준을 충족하는 최초 제출
2014년 11월 17일
처음 게시됨 (추정)
2014년 11월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 10월 6일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 10월 4일
마지막으로 확인됨
2016년 8월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- LCO242-P001
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