NCT05431543已完成2 期
A Multicenter, Double-Masked Evaluation of the Safety and Effectiveness of Aceclidine + Brimonidine (LNZ101) and Aceclidine (LNZ100) in the Treatment of Presbyopia
Alisyn Facemire5 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2022年8月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 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.
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 (Care Provider, Investigator, Outcomes Assessor)
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
- •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 spherical equivalent (SE) results in myopia no more severe than -4.00D MRSE. See Inclusion 5 below) in both eyes determined by manifest refraction documented at Visit 1;
- •Have ≤ 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
- •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 defined as total corneal fluorescein staining at Visit 1;
- •Have clinically significant abnormal lens findings 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
Combination ophthalmic solution (LNZ101) dosed bilaterally
Experimental
LNZ 101: Aceclidine/Brimonidine combination ophthalmic solution
干预措施: Aceclidine+Brimonidine combination ophthalmic solution (Drug)
Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally
Experimental
LNZ 100: Aceclidine ophthalmic solution
干预措施: Aceclidine ophthalmic solution (Drug)
Vehicle Ophthalmic Solution dosed bilaterally
Experimental
Proprietary vehicle ophthalmic solution
干预措施: Vehicle proprietary 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
研究者
Alisyn Facemire
Director of Clinical Operations
LENZ Therapeutics, Inc
研究点 (5)
Loading locations...
相似试验
已完成
2 期
Evaluation of the Safety and Effectiveness of Aceclidine/Brimonidine (LNZ101) and Aceclidine (LNZ100) in the Treatment of PresbyopiaRefractive ErrorsEye DiseasesPresbyopiaNCT05294328LENZ Therapeutics, Inc62
已完成
3 期
Study of Aclidinium Bromide/Formoterol Fumarate Compared With Salmeterol/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)Chronic Obstructive Pulmonary Disease (COPD)NCT01908140AstraZeneca933
已完成
4 期
BENEFITS OF ACLIDINIUM BROMIDE IN THE RELIEF OF COPD SYMPTOMS INCLUDING COUGHPulmonary Disease, Chronic ObstructiveNCT02375724AstraZeneca300
终止
2 期
Comparison of Aclidinium Bromide and Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)Pulmonary Disease, Chronic ObstructiveNCT00706914AstraZeneca156
已完成
3 期
Efficacy and Safety of Aclidinium Bromide 400 µg BID (Twice a Day)Compared to Placebo in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)Chronic Obstructive Pulmonary Disease (COPD)NCT01471171AstraZeneca112