A Multi-Center, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Study Evaluating the Safety of a Novel Contact Lens Used Daily in Healthy, Normal Volunteers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 310
- 试验地点
- 3
- 主要终点
- Lid and Lid Margin Erythema, Change From Baseline
研究概览
简要总结
The purpose of this study is to evaluate the safety of a novel contact lens in healthy normal volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy normal, soft contact lens wearing volunteers
- •normal ocular health
- •contact lens correction from +6.00 to -12.00D in each eye and astigmatism of -1.00D or less in each eye
排除标准
- •active ocular infection
- •history of ocular surgery
- •use of topical ophthalmic preparations (including rewetting drops)
- •pregnancy or lactation
结局指标
主要结局
Lid and Lid Margin Erythema, Change From Baseline
时间窗: baseline and 12 weeks
Assessment of lid redness using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
Lid and Lid Margin Swelling, Change From Baseline
时间窗: baseline and 12 weeks
Assessment of lid swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
Conjunctival Redness, Change From Baseline
时间窗: baseline and 12 weeks
Assessment of redness of conjunctiva using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
Conjunctival Chemosis, Change From Baseline
时间窗: baseline and 12 weeks
Assessment of swelling of the conjunctiva using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
Corneal Edema, Change From Baseline
时间窗: baseline and 12 weeks
Assessment of corneal swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
Corneal Erosion, Change From Baseline
时间窗: baseline and 12 weeks
Assessment of corneal erosion using the following scale: 0=none, 1=mild, 2=moderate, 3=severe.
Corneal Endothelial, Change From Baseline
时间窗: baseline and 12 weeks
Assessment of the posterior cornea using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
Lens Pathology, Change From Baseline
时间窗: baseline and 12 weeks
Assessment of the clarity of the intraocular lens using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
Flare in Anterior Chamber, Change From Baseline
时间窗: baseline and 12 weeks
Assessment of visible protein in the anterior chamber using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
Cells in Anterior Chamber, Change From Baseline
时间窗: baseline and 12 weeks
Assessment of visible cells in the anterior chamber using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
Corneal Staining - Nasal, Change From Baseline
时间窗: baseline and 12 weeks
Assessment of changes to the surface of cornea, the region towards the nose, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
Corneal Staining - Temporal, Change From Baseline
时间窗: baseline and 12 weeks
Assessment of changes to the surface of the cornea, the region towards the outer edge of the face, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
Corneal Staining - Inferior, Change From Baseline
时间窗: baseline and 12 weeks
Assessment of changes to the surface of the cornea, the bottom region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
Corneal Staining - Superior, Change From Baseline
时间窗: baseline and 12 weeks
Assessment of changes to the surface of the cornea, upper region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
Corneal Staining - Central, Change From Baseline
时间窗: baseline and 12 weeks
Assessment of changes to the surface of the cornea, central region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
Intraocular Pressure, Change From Baseline
时间窗: baseline and 12 weeks
Dilated Ophthalmoscopy - Fundus, Change From Baseline
时间窗: baseline and 12 weeks
Assessment of changes in abnormalities on the back part of the eye, using the scale: 0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe.
Dilated Ophthalmoscopy - Vitreous, Change From Baseline
时间窗: baseline and 12 weeks
Assessment of changes in the vitreous (gel-like fluid of the eye), using the scale: 0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe.
Visual Acuity Assessment
时间窗: at 12 weeks
Visual acuity was assessed by the investigator using a Snellen visual acuity chart. This outcome counts the number of eyes that had vision of 20/40 or better at the 12 week visit.
次要结局
未报告次要终点