A Double-Masked Comparison of Apraclonidine Hydrochloride Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 5
- 主要终点
- Mean change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Apraclonidine Hydrochloride Ophthalmic Solution
One drop in each eye on Day 1, followed by 2 drops in each eye on Day 2 onward for approximately 8 weeks
干预措施: Apraclonidine Hydrochloride Ophthalmic Solution (Drug)
Vehicle
One drop in each eye on Day 1, followed by 2 drops in each eye on Day 2 onward for approximately 8 weeks
干预措施: Vehicle (Drug)
结局指标
主要结局
Mean change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1
时间窗: Day 1: Pretreatment; 15 minutes post-treatment
Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe). This endpoint is co-primary with the 10 hours post-instillation endpoint.
Mean change from baseline in investigator-assessed ocular redness at 10 hours (600 minutes) post-instillation on Day 1
时间窗: Day 1: Pretreatment; 10 hours (600 minutes) post-treatment
Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe). This endpoint is co-primary with the 15 minutes post-instillation endpoint.
次要结局
- Mean change from baseline in investigator-assessed ocular redness at 8 hours (480 minutes) post-instillation on Day 1(Day 1: Pretreatment; 8 hours (480 minutes) post-treatment)
- Mean change from baseline in investigator-assessed ocular redness at 1 minute post-instillation on Day 1(Day 1: Pretreatment; 1 minute post-treatment)
- Mean change from baseline in investigator-assessed ocular redness at 12 hours (720 minutes) post-instillation on Day 1(Day 1: Pretreatment; 12 hours (720 minutes) post-treatment)