Performance of Toric Silicone Hydrogel Contact Lenses Following Two Weeks of Daily Wear
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Post Blink Movement
研究概览
简要总结
Prospective study to evaluate the clinical performance of fanfilcon A toric contact lens and senofilcon A toric contact lens after two weeks of wear.
详细描述
The aim of this prospective study is to evaluate the clinical performance of Avaira Vitality toric and ACUVUE OASYS® for ASTIGMATISM contact lenses after 2-weeks of wear in each pair.
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
- Double (Participant, Investigator)
盲法说明
Double masked (participant and investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is between 18 and 40 years of age (inclusive)
- •Has had a self-reported visual exam in the last two years
- •Is an adapted soft contact lens wearer
- •Has a contact lens spherical prescription between +6.00 to - 9.00 (inclusive)
- •Have no less than -0.75D of astigmatism and no more than -2.25 D in both eyes.
- •Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
- •Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
- •Has clear corneas and no active ocular disease
- •Has read, understood and signed the information consent letter.
- •Patient contact lens refraction should fit within the available parameters of the study lenses.
- •Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so).
- •Is willing to comply with the visit schedule
排除标准
- •Has a CL prescription outside the range of the available parameters of the study lenses.
- •Has a spectacle cylinder less than -0.75D or more than -2.50 D of cylinder in either eye.
- •Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
- •Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
- •Presence of clinically significant (grade 2-4) anterior segment abnormalities
- •Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
- •Slit lamp findings that would contraindicate contact lens wear such as:
- •Pathological dry eye or associated findings
- •Pterygium, pinguecula, or corneal scars within the visual axis
- •Neovascularization > 0.75 mm in from of the limbus
- •Giant papillary conjunctivitis (GCP) worse than grade 1
- •Anterior uveitis or iritis (past or present)
- •Seborrheic eczema, Seborrheic conjunctivitis
- •History of corneal ulcers or fungal infections
- •Poor personal hygiene
- •Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
- •Has aphakia, keratoconus or a highly irregular cornea.
- •Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
- •Has undergone corneal refractive surgery.
- •Is participating in any other type of eye related clinical or research study.
研究组 & 干预措施
fanfilcon A toric lens
Randomized participants will wear fanfilcon A toric contact lenses bilaterally for two weeks then switch to senofilcon A toric contact lenses for another two weeks.
干预措施: fanfilcon A toric lens (Device)
senofilcon A toric lens
Randomized participants will wear senofilcon A toric contact lenses bilaterally for two weeks then switch to fanfilcon A toric contact lenses for another two weeks.
干预措施: senofilcon A toric lens (Device)
结局指标
主要结局
Post Blink Movement
时间窗: 2 weeks
Amount of lens movement after blink (0-5 Likert Scale, 0=Insufficient, 2=Optimal, 4=Excessive movement)
Lens Centration
时间窗: 2 weeks
Centration of lens on eye (Optimum, Decentration acceptable, Decentration unacceptable)
Corneal Coverage
时间窗: 2 weeks
Lens covering the cornea (Yes, No)
Corneal Coverage
时间窗: Baseline
Lens covering the cornea (Yes, No)
Lens Centration
时间窗: Baseline
Centration of lens on eye (Optimum, Decentration acceptable, Decentration unacceptable)
Post Blink Movement
时间窗: Baseline
Amount of lens movement after blink (0-5 Likert Scale, 0=Insufficient, 2=Optimal, 4=Excessive movement)
次要结局
- Wearing Time(2 weeks)
- Comfortable Wearing Time(2 weeks)