A Multi-Center, Double-Masked Phase 3 Evaluation of the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 229
- 试验地点
- 17
- 主要终点
- Percentage of Participants With a ≥ 3-line Improvement in Near Vision and no Loss ≥ 5 Letters Distance Vision
研究概览
简要总结
Phase 3 Efficacy Study to evaluate the Safety and Efficacy of LNZ100 & LNZ101 for the Treatment of Presbyopia
详细描述
Phase 3 study to evaluate the safety and effectiveness of LNZ101 compared with LNZ100 and Vehicle for the treatment of Presbyopia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-masked treatment will be used to reduce potential of bias during data collection and evaluation of clinical endpoints.
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects MUST:
- •Be able and willing to provide written informed consent and sign a Health Information Portability and Accountability Act (HIPAA) form prior to any study procedure being performed;
- •Be able and willing to follow all instructions and attend all study visits;
- •Be 45-75 years of age of either sex and any race or ethnicity at Visit 1;
- •Have +1.00 to -4.00 diopter (D) of sphere calculated in minus cylinder (so that spherical equivalent (SE) results in myopia no more severe than -4.00 D MRSE) in both eyes determined by manifest refraction documented at Visit 1;
- •Have ≤2.00 D of cylinder (minus cylinder) in both eyes determined by manifest refraction documented at Visit 1;
- •Be presbyopic as determined at Visit 1
排除标准
- •Subjects must NOT:
- •Be a female of childbearing potential who is currently pregnant, nursing, or planning a pregnancy;
- •Have known contraindications or sensitivity to the use of any of the study medications or their components;
- •Have an active ocular infection at Visit 1 or at Visit 2 (bacterial, viral, or fungal), positive history of an ocular herpetic infection, preauricular lymphadenopathy, or ongoing, active ocular inflammation in either eye;
- •Have moderate or severe dry eye defined as total central corneal fluorescein staining in either eye at Visit 1;
- •Have clinically significant abnormal lens findings including early lens changes during dilated slit lamp biomicroscopy and fundus exam documented within 3 months of Visit 1 or at Visit 1;
研究组 & 干预措施
Aceclidine + Brimonidine (LNZ101) dosed bilaterally
LNZ101: Aceclidine + Brimonidine ophthalmic solution
干预措施: Aceclidine+Brimonidine combination ophthalmic solution (Drug)
Vehicle Ophthalmic Solution dosed bilaterally
Vehicle ophthalmic solution
干预措施: Vehicle (Drug)
Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally
LNZ100: Aceclidine ophthalmic solution
干预措施: Aceclidine ophthalmic solution (Drug)
结局指标
主要结局
Percentage of Participants With a ≥ 3-line Improvement in Near Vision and no Loss ≥ 5 Letters Distance Vision
时间窗: 3 hours post-treatment in the study eye on Day 1
Percentage of participants with at least a 3-line improvement in near vision and no loss ≥ 5 letters distance vision on Day 1
次要结局
未报告次要终点