Performance of Toric Silicone Hydrogel Contact Lenses Following One Month of Daily Wear
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Lens Centration
研究概览
简要总结
The aim of this prospective study is to evaluate the clinical performance of fanfilcon A toric and lotrafilcon B toric contact lenses after 1 month of wear in each pair.
详细描述
The aim of this prospective study is to evaluate the clinical performance of Avaira Vitality toric (fanfilcon A) and AIR OPTIX for Astigmatism (lotrafilcon B) contact lenses after 1 month 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)
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
- •A person will be excluded from the study if he/she:
- •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.
结局指标
主要结局
Lens Centration
时间窗: 1 Month
Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable)
Corneal Coverage
时间窗: 1 Month
Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete)
Post-blink Movement
时间窗: 1 Month
Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement)
Overall Fit Acceptance
时间窗: 1 Month
Assessed by investigator based on lens fit alone (0-4 scale; 0=should not be worn, 4=perfect)
次要结局
- Average Comfortable Wearing Time(1 Month)
- Average Hours of Wear Per Day(1 month)