OPSIS: A Phase IIa, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Multicenter Study Assessing the Efficacy and Safety of STN1013600 Ophthalmic Solution 0.1% and 0.3% Compared With Placebo in Subjects With Presbyopia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Santen Inc.
- 入组人数
- 79
- 试验地点
- 12
- 主要终点
- Mean Change From Baseline in Binocular Distance Corrected Near Visual Acuity (DCNVA)
研究概览
简要总结
This is a Phase IIa study to assess efficacy and safety of STN1013600 ophthalmic solution (0.1%, and 0.3 %), twice daily when compared to Placebo in subjects diagnosed with presbyopia. This study will consist of a Screening Period of up to 15 days followed by a 2 Month Treatment Period. After the Treatment Period subjects will be followed for a one-month treatment free period.
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)
入排标准
- 年龄范围
- 47 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Phakic presbyopic subjects, Male or Female between 47 and 55 years of age.
- •Distance-corrected near visual acuity (DCNVA) for each eye, as well as for binocular vision, 70 EDTRS letters or worse (equivalent to 0.3 logMAR or worse; or 20/40 Snellen or worse) at 40 cm. To be reconfirmed at Visit 2 (Baseline).
- •Best-corrected distance visual acuity (BCDVA) for each eye of 85 ETDRS letters or better (equivalent to 0.00 logMAR or better; or 20/20 Snellen or better) at 4 m. To be reconfirmed at Visit 2 (Baseline).
排除标准
- •Secondary cause of presbyopia in either eye as assessed by investigator (e.g., damage to lens, zonules or ciliary muscle, multiple sclerosis, cardiovascular accidents, vascular insufficiency, myasthenia gravis, anemia, influenza, measles).
- •Any history of ocular surgery (including ocular laser surgery) in either eye or plan of ocular surgery (including ocular laser surgery) during the course of the study.
- •Prior invasive therapy for presbyopia (e.g., ciliary body electrostimulation, corneal implants).
研究组 & 干预措施
0.1% STN1013600 ophthalmic solution
0.1% STN1013600 ophthalmic solution 1 drop BID
干预措施: 0.1% STN1013600 ophthalmic solution (Drug)
0.3% STN1013600 ophthalmic solution
0.3% STN1013600 ophthalmic solution 1 drop BID
干预措施: 0.3% STN1013600 ophthalmic solution (Drug)
Placebo (Vehicle) ophthalmic solution
Placebo (Vehicle) ophthalmic solution BID
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Baseline in Binocular Distance Corrected Near Visual Acuity (DCNVA)
时间窗: At Month 2
Analysis of Change from Baseline at Month 2 was done using Bayesian Approach Analysis Population.
次要结局
- Mean Change From Baseline in Study Eye Distance Corrected Near Visual Acuity (DCNVA) at Month 2(Month 2)
- Percentage of Participants Who Improved 1/2/3-lines or More in Study Eye and Binocular Distance Corrected Near Visual Acuity (DCNVA) at Month 2(Month 2)
- Mean Change From Baseline in Quality of Life Assessed With Near Activity Visual Questionnaire (NAVQ) at Month 2(Month 2)
- Subject Treatment Satisfaction as Assessed by Patient Global Rating of Treatment(Month 2)