A Multicenter, Double-Masked Evaluation of the Safety and Effectiveness of Aceclidine /Brimonidine (LNZ101) and Aceclidine (LNZ100) in the Treatment of Presbyopia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 5
- 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
To evaluate the safety and effectiveness of Aceclidine/Brimonidine (LNZ101) compared with Aceclidine (LNZ100) and vehicle in the treatment of Presbyopia.
详细描述
The primary efficacy variable in this INSIGHT study is the percentage of subjects with at least a 3-line improvement.
The secondary efficacy variable is the percentage of subjects who achieve a 2-line or greater improvement from pre-treatment.
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
- Triple (Participant, Care Provider, Investigator)
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 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 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 (so that SE results in myopia no more severe than -4.00 SE. See Inclusion 5 below) in both eyes determined by manifest refraction documented at Visit 1;
- •Have up to 2.00D 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(s) or their components;
- •Have an active ocular infection at Visit 1 (bacterial, viral or fungal), positive history of an ocular herpetic infection, preauricular lymphadenopathy, or ongoing, active ocular inflammation (e.g., moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis, scleritis, uveitis) in either eye;
- •Have moderate or severe dry eye determined by total corneal fluorescein staining at Visit 1;
- •Have clinically significant abnormal lens findings (e.g., cataract) including early lens changes and/or any evidence of a media opacity in either eye during dilated slit-lamp biomicroscopy and fundus exam documented within 3 months of Visit 1;
研究组 & 干预措施
Vehicle Ophthalmic Solution dosed bilaterally
Proprietary Vehicle ophthalmic solution
干预措施: Vehicle Proprietary Ophthalmic Solution (Drug)
Combination ophthalmic solution (LNZ101) dosed bilaterally
LNZ101: Aceclidine/Brimonidine combination ophthalmic solution
干预措施: Aceclidine+Brimonidine combination ophthalmic solution (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: 1 hour post treatment
Percentage of participants with at least a 3-line improvement in near vision and no loss ≥ 5 letters distance vision
次要结局
未报告次要终点