Clinical Performance of Existing Wearers of Avaira Sphere (Enfilcon A) Following a Refit With Clariti Elite Sphere (Somofilcon A) Lenses for 4 Weeks
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Visual Acuity - Enfilcon A and Somofilcon A
研究概览
简要总结
The aim of this dispensing study is to evaluate the clinical performance of existing wearers of Avaira sphere lenses following a refit with Clariti Elite sphere over 4 weeks of daily wear.
详细描述
This is a 30-subject, prospective dispensing study comparing the clinical performance of the subjects' habitual Avaira sphere lenses following a refit with Clariti Elite sphere lenses. Subject's habitual Avaira sphere lenses will be evaluated at the first visit and then re-fitted with a pair of Clariti Elite sphere lenses for 4 weeks of daily wear. After the dispensing visit, subjects will return for evaluations at 1 week, 2 weeks and 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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 Avaira sphere contact lens (CL) wearer (at least 1 week in Avaira sphere)
- •Has a contact lens spherical prescription between -1.00 to - 6.00 (inclusive)
- •Has a spectacle cylinder up to 0.75D in each eye.
- •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
- •Is not a habitual wearer of Avaira sphere lenses
- •Has a contact lens prescription outside the range of the available parameters of the study lenses.
- •Has a spectacle cylinder ≥1.00D 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
Visual Acuity - Enfilcon A and Somofilcon A
时间窗: Baseline, 1 Week, 2 Week, 4 Week
Monocular and binocular logMAR visual acuity for enfilcon A / somofilcon A assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week.
Subjective Assessments. - Enfilcon A and Somofilcon A
时间窗: Baseline, 1 Week, 2 Week, 4 Week
Subjective assessments for: comfort, dryness, handling, overall vision satisfaction, and eye whiteness. Enfilcon A was assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week. Scale(s): comfort (0=very poor; 10=excellent), dryness (0=very dry; 10=no dryness), handling (0=very difficult; 10=very easy), overall vision satisfaction (0=very unsatisfied; 10=very satisfied), habitual eye whiteness (0=not white; 10= totally white)
次要结局
未报告次要终点