A 3-month, Randomized, Placebo-controlled, Double-masked, Multi-center Study to Evaluate the Safety and Efficacy of Topical Ocular UNR844-Cl in Subjects With Presbyopia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Change in Binocular Distance-corrected Near Visual Acuity (DCNVA) From Baseline
研究概览
简要总结
The purpose of this study was to assess the effect of topical UNR844-Cl (lipoic acid choline ester chloride) ophthalmic solution on near visual function in presbyopic subjects.
详细描述
This was a multi-center, double-masked, placebo-controlled, randomized, parallel-group study. The total duration of the study was approximately 3 months. Approximately 120 presbyopic subjects were to be enrolled into the study.
Presbyopic subjects aged 45 to 55 years were the primary age group in this study.
Screening and Baseline: Subjects were screened for eligibility followed by a baseline visit after which they were randomized to receive either UNR844-Cl (1.5%, equivalent to 1.3% freebase) or Placebo, dosed one drop in each eye twice daily, for 3 months.
Randomized subjects attended the following study visits after baseline: at Week 2, Month 1, Month 2 and Month 3.
The primary objective of this study was to assess the efficacy of UNR844-Cl on binocular distance corrected near visual acuity (DCNVA) in presbyopic subjects aged 45 to 55 years with the primary endpoint being the change from baseline in binocular DCNVA in subjects aged 45 to 55 years at Month 3 after UNR844-Cl or Placebo treatment.
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
- Double (Participant, Investigator)
盲法说明
double-mask(Investigator, patient)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent must be obtained before any assessment is performed
- •Impaired near vision in each eye and when using both eyes, without any near correction
- •Need a certain level of near correction
排除标准
- •Impaired distance vision in either eye, with distance correction (if any)
- •Severe short- or long-sightedness
- •Any significant medical or clinical conditions affecting vision, the eyes or general health
研究组 & 干预措施
UNR844-Cl Ophthalmic Solution
1.5% UNR844-Cl ophthalmic solution for twice-daily dosing
干预措施: UNR844-Cl (Drug)
Placebo Ophthalmic Solution
placebo ophthalmic solution for twice-daily dosing
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Binocular Distance-corrected Near Visual Acuity (DCNVA) From Baseline
时间窗: Baseline and at Month 3
Change from baseline in binocular DCNVA in subjects aged 45 to 55 years at Month 3 after UNR844-Cl or placebo treatment. Low contrast (10% contrast) DCNVA at 40 cm is measured binocularly using an electronic visual acuity testing system. This assessment was performed with subjects corrected for any distance refractive errors. The system provided distance-corrected low contrast near visual acuity in an Early Treatment Diabetic Retinopathy Study (ETDRS) letter numerical score. High monocular DCNVA ETDRS letter scores represent good vision; Low monocular DCNVA ETDRS letter scores represent poor vision.
次要结局
- Number and Percentage of Subjects Aged 45 to 55 Years Achieving 75 or More Early Treatment Diabetic Retinopathy Study (ETDRS) Letters in Binocular DCNVA at Month 3(month 3)
- Number of Subjects With Adverse Events, Ocular Adverse Events, Deaths, Other Serious Adverse Events, or Adverse Events Leading to Study Drug Discontinuation(4 months)