A Multicenter, Randomized, Vehicle-Controlled Evaluation of the Efficacy and Safety of FID 123472 Ophthalmic Solution for the Reduction of Ocular Redness in Adult Subjects
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 178
- 试验地点
- 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 caused by minor eye irritations.
详细描述
Eligible subjects will be expected to attend a total of 6 in-office study visits over a period of approximately 10 weeks. Subjects will receive a single dose of study treatment in each eye (either Apraclonidine 0.125% UDPF or Vehicle) on Day 1, after which subjects will be instructed to self-administer one drop in each eye twice daily at home for a total of approximately 8 weeks (Days 2-55), with the last dose administered on Day 56 in office. Subjects will then return for the final study visit on Day 63, following a 1-week treatment discontinuation. Eye redness will be assessed before and after instillation 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 ocular redness score of 0.5 unit or higher in at least one eye at Visit 1 and greater than 1 unit on a 5-point scale in both eyes prior to randomization at Visit
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Known contraindications or sensitivity to the use of any of the study treatment(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.
- •Any ocular condition that, in the opinion of the investigator, may compromise the subject's safety or study parameters.
- •Use of prohibited medications, devices, or treatments as specified in the 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, followed by one drop in each eye twice daily (approximately 12 hours apart, but not less than 11.5 hours apart) beginning the day following Day 1 up until the day prior to Day 56. On the day of Day 56, subjects will receive the last dose in-office.
干预措施: Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free (Drug)
Vehicle
One drop in each eye on Day 1, followed by one drop in each eye twice daily (approximately 12 hours apart, but not less than 11.5 hours apart) beginning the day following Day 1 up until the day prior to Day 56. On the day of Day 56, subjects will receive the last dose in-office.
干预措施: Vehicle (Drug)
结局指标
主要结局
未指定
次要结局
- Number of subjects who achieve prespecified improvements from baseline in investigator-assessed ocular redness score in both eyes at 30 seconds post-instillation on Day 1(Baseline (Day 1 pretreatment); 30 seconds post-instillation (Day 1))