A Phase 3b Study to Evaluate 0.003% AR-15512 Safety and Drop Attributes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 6
- 主要终点
- Percentage of Subjects With Ocular Treatment-Emergent Adverse Events Attributed to Study Intervention
研究概览
简要总结
The purpose of this study is to evaluate the percentage of ocular adverse events reported in subjects with dry eye disease (DED) between the intervention arm (0.003% AR-15512) and control arm (REFRESH® Classic).
详细描述
Subjects will be randomized to one of four sequences of 0.003% AR-15512 ophthalmic solution instillation variations which will be administered after administration of control (REFRESH® Classic). This is a 1-visit study (Screening, Enrollment, Assessments).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
In this single arm study, the subject is masked as to when they receive the Refresh Classic.
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
- •Corrected Visual Acuity (Snellen) 20/200 or better in both eyes;
- •Good general and ocular health, as determined by the Investigator using medical history, ophthalmic examination and history;
- •Capable of giving signed informed consent.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Current evidence of other clinically significant ophthalmic disease other than dry eye;
- •History of ocular surgery within 1 year of the Study Visit;
- •Use of any topical ocular anti-inflammatory medications (for example, Restasis®, Cequa™, Vevye™, Xiidra®), other prescription ophthalmic product for dry eyes, topical ocular corticosteroid, or non-steroidal-anti-inflammatory agents within 30 days of the Study Visit;
- •Positive pregnancy test or currently breastfeeding.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Sequence 1
One drop of artificial tears in the right eye, followed by 0.003% AR-15512 ophthalmic solution in four different instillation variations: 512-RT, then 512-COLD, followed by 512-RT-EC, and finally 512-COLD-EC. Each instillation consisted of 1 drop in 1 eye only starting with the left eye and alternating the eyes thereafter. Protocol-specified wait periods separated each instillation.
干预措施: 0.003% AR-15512 ophthalmic solution (Drug)
Sequence 1
One drop of artificial tears in the right eye, followed by 0.003% AR-15512 ophthalmic solution in four different instillation variations: 512-RT, then 512-COLD, followed by 512-RT-EC, and finally 512-COLD-EC. Each instillation consisted of 1 drop in 1 eye only starting with the left eye and alternating the eyes thereafter. Protocol-specified wait periods separated each instillation.
干预措施: Artificial tears (Drug)
Sequence 2
One drop of artificial tears in the right eye, followed by 0.003% AR-15512 ophthalmic solution in four different instillation variations: 512-RT-EC, then 512-RT, followed by 512-COLD-EC, and finally 512-COLD. Each instillation consisted of 1 drop in 1 eye only starting with the left eye and alternating the eyes thereafter. Protocol-specified wait periods separated each instillation.
干预措施: 0.003% AR-15512 ophthalmic solution (Drug)
Sequence 2
One drop of artificial tears in the right eye, followed by 0.003% AR-15512 ophthalmic solution in four different instillation variations: 512-RT-EC, then 512-RT, followed by 512-COLD-EC, and finally 512-COLD. Each instillation consisted of 1 drop in 1 eye only starting with the left eye and alternating the eyes thereafter. Protocol-specified wait periods separated each instillation.
干预措施: Artificial tears (Drug)
Sequence 3
One drop of artificial tears in the right eye, followed by 0.003% AR-15512 ophthalmic solution in four different instillation variations: 512-COLD, then 512-COLD-EC, followed by 512-RT, and finally 512-RT-EC. Each instillation consisted of 1 drop in 1 eye only starting with the left eye and alternating the eyes thereafter. Protocol-specified wait periods separated each instillation.
干预措施: 0.003% AR-15512 ophthalmic solution (Drug)
Sequence 3
One drop of artificial tears in the right eye, followed by 0.003% AR-15512 ophthalmic solution in four different instillation variations: 512-COLD, then 512-COLD-EC, followed by 512-RT, and finally 512-RT-EC. Each instillation consisted of 1 drop in 1 eye only starting with the left eye and alternating the eyes thereafter. Protocol-specified wait periods separated each instillation.
干预措施: Artificial tears (Drug)
Sequence 4
One drop of artificial tears in the right eye, followed by 0.003% AR-15512 ophthalmic solution in four different instillation variations: 512-COLD-EC, then 512-RT-EC, followed by 512-COLD, and finally 512-RT. Each instillation consisted of 1 drop in 1 eye only starting with the left eye and alternating the eyes thereafter. Protocol-specified wait periods separated each instillation.
干预措施: 0.003% AR-15512 ophthalmic solution (Drug)
Sequence 4
One drop of artificial tears in the right eye, followed by 0.003% AR-15512 ophthalmic solution in four different instillation variations: 512-COLD-EC, then 512-RT-EC, followed by 512-COLD, and finally 512-RT. Each instillation consisted of 1 drop in 1 eye only starting with the left eye and alternating the eyes thereafter. Protocol-specified wait periods separated each instillation.
干预措施: Artificial tears (Drug)
结局指标
主要结局
Percentage of Subjects With Ocular Treatment-Emergent Adverse Events Attributed to Study Intervention
时间窗: Up to Day 1 post drop instillation
Treatment-emergent adverse events (TEAEs) were defined as any event that occurred or worsened on or after the day that study intervention was initiated. No hypothesis testing was prespecified for this endpoint.
次要结局
未报告次要终点