A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft as Measured by In-Vivo Confocal Microscopy
연구 개요
연구 유형
등록 (실제)
단계
- 4단계
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Have a positive history of ocular allergies and a positive skin test to protocol defined allergens
- Have a positive CAC reaction at Visit 1
- Have a positive conjunctival inflammation score at Visit 1
Exclusion Criteria:
- May not use disallowed medications in specified washout period
- May not have an ocular or system disease the investigator feels with impact subject safety or trial parameters
- May not have active ocular infection
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Lastacaft ®
One drop Lastacaft ® in right eye or left eye based on randomization list once on Day 1 and once on Day 2
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위약 비교기: Tears Naturale ®
One drop Tears Naturale ® in right eye or left eye based on randomization list once on Day 1 and once on Day 2
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Conjunctival Inflammation at 1 Hour (+30 Minutes) Post CAC on Day 1
기간: 1 hour (+30 minutes) post CAC on Day 1
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Conjunctival Inflammation was assessed by a trained technician post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0 = best [least inflammation] and 4 = worst [most inflammation]). The Conjunctival Inflammation was averaged across all Lastacaft-treated eyes to create the average Lastacaft eye Conjunctival Inflammation score, and the Conjunctival Inflammation score was averaged across all Tears Naturale-treated eyes to create the average Tears Naturale eye Conjunctival Inflammation score. |
1 hour (+30 minutes) post CAC on Day 1
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Conjunctival Inflammation 1 Hour (+30 Minutes) Post CAC on Day 2
기간: 1 hour (+30 minutes) post CAC on Day 2
|
Conjunctival Inflammation was assessed by a trained technician post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0 = best [least inflammation] and 4 = worst [most inflammation]). The Conjunctival Inflammation was averaged across all Lastacaft-treated eyes to create the average Lastacaft eye Conjunctival Inflammation score, and the Conjunctival Inflammation score was averaged across all Tears Naturale-treated eyes to create the average Tears Naturale eye Conjunctival Inflammation score. |
1 hour (+30 minutes) post CAC on Day 2
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Ocular Itching on Day 1 (15 Minutes Post-study Medication Instillation)
기간: 15 minutes post-study medication instillation
|
CAC was performed 15 minutes after study medication instillation.
Ocular Itching was assessed by the patient on a 0-4 scale (0 = best [no itching] to 4 = worst [severe itching]).
The ocular itching score was averaged across all Lastacaft-treated eyes to create the average Lastacaft eye ocular itching score, and the ocular itching score was averaged across all Tears Naturale-treated eyes to create the average Tears Naturale eye ocular itching score.
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15 minutes post-study medication instillation
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Ocular Itching on Day 2 (15 Minutes Post-study Medication Instillation)
기간: 15 minutes post-study medication instillation
|
CAC was performed 15 minutes after study medication instillation.
Ocular Itching was assessed by the patient on a 0-4 scale (0 = best [no itching] to 4 = worst [severe itching]).
The ocular itching score was averaged across all Lastacaft-treated eyes to create the average Lastacaft eye ocular itching score, and the ocular itching score was averaged across all Tears Naturale-treated eyes to create the average Tears Naturale eye ocular itching score.
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15 minutes post-study medication instillation
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 14-100-0012
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Lastacaft ®에 대한 임상 시험
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Chung-Ang University Hosptial, Chung-Ang University...알려지지 않은
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Novartis Pharmaceuticals완전한
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Guerbet완전한원발성 뇌종양콜롬비아, 대한민국, 미국, 멕시코