A Two-Arm Multicenter Clinical Trial to Investigate Efficacy and Safety of FID123472 Ophthalmic Solution Compared With Vehicle in Adult Subjects With Ocular Redness
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Mean change from baseline (pretreatment) 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 evaluate the efficacy and safety of an investigational ophthalmic solution in adults with ocular redness due to minor eye irritations.
详细描述
Eligible subjects will be expected to attend a total of 3 in-office study visits over a period of approximately 1 week. Subjects will receive a single dose of the study treatment in each eye on Day 1 (Visit 2). Eye redness will be assessed before and after instillations at prespecified timepoints.
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 and comply with the requirements listed in the Informed Consent Form.
- •Willing and able to follow all instructions and attend all study visits.
- •History of redness relief eyedrop use within the last 6 months, or an interest in using over-the-counter redness relief drops, or would benefit from the use of redness relief drops in the investigator's opinion.
- •Baseline investigator-assessed ocular redness score of 0.5 or higher in at least one eye at Visit 1 when applicable and a score of greater than 1.0 in both eyes on a 5-point scale prior to randomization on Day 1 (Visit 2).
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Known contraindications or sensitivity to the use of any of the investigational product(s) or their components, or any other medication required by the protocol.
- •Ocular surgical intervention within 6 months prior to Visit 1 or during the study.
- •Any ocular condition that, in the opinion of the investigator, may compromise the subject's safety or study specific parameters.
- •Use of any of the prohibited medications or devices as specified in the study protocol.
- •Out-of-range vital signs (blood pressure and/or pulse rate) as defined in the study protocol.
- •Abnormal intraocular pressure.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free
One drop in each eye on Day 1 (single dose)
干预措施: Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free (Drug)
Vehicle
One drop in each eye on Day 1 (single dose)
干预措施: Vehicle (Drug)
结局指标
主要结局
Mean change from baseline (pretreatment) in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1
时间窗: Baseline (Day 1 pretreatment); 15 minutes post-instillation (Day 1)
Ocular redness will be assessed by the investigator and recorded per the Ora Calibra® Ocular Hyperemia Scale, which ranges 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). Change from baseline, calculated as post-instillation minus baseline score, 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.
Mean change from baseline (pretreatment) in investigator-assessed ocular redness at 840 minutes (14 hours) post-instillation on Day 2
时间窗: Baseline (Day 1 pretreatment); 840 minutes (14 hours) post-instillation (Day 2)
Ocular redness will be assessed by the investigator and recorded per the Ora Calibra® Ocular Hyperemia Scale, which ranges 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). Change from baseline, calculated as post-instillation minus baseline score, 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.
次要结局
- Mean change from baseline (pretreatment) in investigator-assessed ocular redness at 1 minute post-instillation on Day 1(Baseline (Day 1 pretreatment); 1 minute post-instillation (Day 1))
- Mean change from baseline (pretreatment) in investigator-assessed ocular redness at 960 minutes (16 hours) post-instillation on Day 2(Baseline (Day 1 pretreatment); 960 minutes (16 hours) post-instillation (Day 2))