안구 홍조 감소를 위한 FID 123320 안과 용액과 차량의 이중 마스크 비교
안구 충혈 감소를 위한 아프라클로니딘 염산염 점안액과 약물의 이중 마스크 비교
The purpose of this study is to assess the safety and efficacy of Apraclonidine Hydrochloride Ophthalmic Solution 0.125% when compared to Vehicle in relieving redness of the eye due to minor eye irritations. This study will be conducted in the United States.
연구 개요
상세 설명
The study will consist of six (6) scheduled visits: Screening and/or Baseline Visit (Day -7 to -1), Eligibility Confirmation/Randomization/1st Treatment Visit (Day 1), Week 2 Follow-Up Visit (Day 14), Week 4 Follow-Up Visit (Day 28), Week 8 Follow-Up/Treatment Discontinuation Visit (Day 56) and Exit Visit (Day 63). The expected individual duration of participation in the study is approximately 10 weeks with approximately 56 days of exposure to the investigational product.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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California
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Glendale, California, 미국, 91204
- Global Research Management
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North Carolina
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Garner, North Carolina, 미국, 27529
- Oculus Research, Inc.
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Pennsylvania
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Cranberry Township, Pennsylvania, 미국, 16066
- Scott & Christie and Associates, PC
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Virginia
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Falls Church, Virginia, 미국, 22046
- Emerson Clinical Research Institute, Inc.
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Lynchburg, Virginia, 미국, 24502
- Piedmont Eye Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Key Inclusion Criteria:
- Capable of giving signed informed consent;
- Willing and able to follow all instructions and attend all study visits;
- Able to self-administer eye drops- in the opinion of the investigator;
- History of redness relief drop use within the last 6 months, or a desire to use over-the-counter (OTC) eye drops for redness relief;
- Females capable of becoming pregnant: Agree to urine pregnancy tests and the use of medically acceptable forms of birth control throughout the study;
- Ocular health within normal limits, including best-corrected visual acuity (BCVA) of 20/40 or better in each eye as measured using a Snellen chart;
- Ocular redness at baseline as specified in the protocol;
- Other protocol-specified inclusion criteria may apply.
Key Exclusion Criteria:
- Known contraindications or sensitivities to the use of any of the investigational drug(s) or their components, or any other medication required by the protocol;
- Ocular surgical interventions within 6 months prior to Visit 1 or during the study;
- Ocular conditions that, in the opinion of the investigator, could affect the subject's safety or study parameters (i.e., could affect ocular redness, intraocular pressure, or eyelid position);
- Disallowed medications or devices as specified in the protocol;
- Planned surgery (ocular or systemic) during the study period or within 30 days after the study period;
- Other protocol-defined exclusion criteria may apply.
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 |
|---|---|
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실험적: Apraclonidine HCl 0.125%
1 drop instilled in each eye at Visit 2 (Day 1), followed by one drop instilled in each eye twice a day (approximately 12 hours apart) Day 2 up to Visit 5 (Day 56), followed by 1 drop instilled in each eye at Visit 5 (Day 56). |
Investigational ophthalmic solution applied topically to the eye with a dropper bottle
다른 이름들:
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위약 비교기: Vehicle
1 drop instilled in each eye at Visit 2 (Day 1), followed by one drop instilled in each eye twice a day (approximately 12 hours apart) Day 2 up to Visit 5 (Day 56), followed by 1 drop instilled in each eye at Visit 5 (Day 56). |
Vehicle (inactive ingredients) applied topically to the eye with a dropper bottle |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 15 Minutes Post-instillation on Day 1
기간: Baseline (Day 1 pre-instillation); Minute 15 (Day 1 post-instillation)
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Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). The change from baseline, calculated as post-instillation minus baseline scores, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). This is a co-primary endpoint. |
Baseline (Day 1 pre-instillation); Minute 15 (Day 1 post-instillation)
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Least Squares Mean Change From Baseline in Investigator-assessed Ocular Redness at 10 Hours (600 Minutes) Post-instillation on Day 1
기간: Baseline (Day 1 pre-instillation); Hour 10 (600 minutes) (Day 1 post-instillation)
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Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). The change from baseline, calculated as post-instillation minus baseline scores, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). This is a co-primary endpoint. |
Baseline (Day 1 pre-instillation); Hour 10 (600 minutes) (Day 1 post-instillation)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Least Squares Mean Change From Baseline in Investigator-assessed Ocular Redness at 1 Minute Post-instillation on Day 1
기간: Baseline (Day 1 pre-instillation); Minute 1 (Day 1 post-instillation)
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Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). The change from baseline, calculated as post-instillation minus baseline scores, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). |
Baseline (Day 1 pre-instillation); Minute 1 (Day 1 post-instillation)
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Least Squares Mean Change From Baseline in Investigator-assessed Ocular Redness at 8 Hours (480 Minutes) Post-instillation on Day 1
기간: Baseline (Day 1 pre-instillation); Hour 8 (480 minutes) (Day 1 post-instillation)
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Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). The change from baseline, calculated as post-instillation minus baseline scores, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). |
Baseline (Day 1 pre-instillation); Hour 8 (480 minutes) (Day 1 post-instillation)
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Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 12 Hours (720 Minutes) Post-instillation on Day 1
기간: Baseline (Day 1 pre-instillation); Hour 12 (720 minutes) (Day 1 post-instillation)
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Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). The change from baseline, calculated as post-instillation minus baseline scores, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). |
Baseline (Day 1 pre-instillation); Hour 12 (720 minutes) (Day 1 post-instillation)
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공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Principal Clinical Trial Lead, Pharma, Alcon Research, LLC
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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