NCT05753189已完成3 期
Safety Study: A Multi-Center, Double-Masked Phase 3 Safety Study Evaluation of the Long-Term Safety of LNZ101 in Presbyopic Subjects
LENZ Therapeutics, Inc76 个研究点 分布在 1 个国家目标入组 362 人开始时间: 2023年2月21日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 362
- 试验地点
- 76
- 主要终点
- Primary Objective
研究概览
简要总结
Safety Study of the Long-Term Safety of LNZ100 & LNZ101 in Presbyopic Subjects
详细描述
Safety Study: Multi-Center, Double-Masked Phase 3 Evaluation of the Long-Term Safety of LNZ101 compared with LNZ100 in Presbyopic Subjects
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double-masked treatment will be used to reduce potential of bias during data collection and the 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
- •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
- •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
Combination ophthalmic solution (LNZ101) dosed bilaterally
Experimental
LNZ 101: Aceclidine/Brimonidine Ophthalmic Solution
干预措施: Aceclidine+Brimonidine combination ophthalmic solution (Drug)
Aceclidine ophthalmic solution dosed bilaterally
Experimental
LNZ 100: Aceclidine ophthalmic solution
干预措施: Aceclidine Ophthalmic Solution (Drug)
结局指标
主要结局
Primary Objective
时间窗: 7 visits over a total duration of approximately 28 weeks
Percentage of subjects who experience adverse events and monocular BCDVA changes at 4m.
次要结局
未报告次要终点
研究者
研究点 (76)
Loading locations...
相似试验
已完成
3 期
Phase 3 Efficacy Study of LNZ100 & LNZ101 for the Treatment of PresbyopiaNear VisionEye DiseasesRefractive ErrorPresbyopiaNCT05728944LENZ Therapeutics, Inc229
已完成
3 期
Phase 3 Evaluation of the Safety and Efficacy of LNZ100 & LNZ101 for the Treatment of PresbyopiaNear VisionMiosisEye DiseasesRefractive ErrorPresbyopiaNCT05656027LENZ Therapeutics, Inc469
已完成
1 期
Study to Evaluate the Safety, Tolerability, and Efficacy of LX7101 in Subjects With Primary Open-angle Glaucoma or Ocular HypertensionPrimary Open-angle GlaucomaOcular HypertensionNCT01528111Lexicon Pharmaceuticals63
已完成
2 期
Safety, Tolerability and Efficacy of PresbiDrops (CSF-1) in Presbyopic SubjectsPresbyopiaNCT02965664Orasis Pharmaceuticals Ltd.36
已完成
1 期
A Phase 1b Study of ONL1204 Ophthalmic Solution in Patients with Progressing Open Angle GlaucomaOpen Angle GlaucomaNCT05160805ONL Therapeutics25