Performance of Aspheric Hydrogel Lenses After a Refit With Sphere Silicone Hydrogel Lenses for 4 Weeks
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
- Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses
研究概览
简要总结
The aim of this prospective study is to evaluate the clinical performance of habitual wearers of methafilcon A aspheric lenses after a refit with fanfilcon A sphere lenses for 4 weeks of daily wear.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
Study lenses will be transferred, by an assistant, out of their packaging to unmarked new contact lens cases filled with unpreserved sterile saline just prior to dispensing to maintain subject masking of the study lenses
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 - 0.25 to - 8.00 (inclusive)
- •Have no less than -0.75D (Diopter) of astigmatism 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 Contact Lens (CL) prescription outside the range of the available parameters of the study lenses
- •Has a spectacle cylinder of ≥ 1.00D (Diopter) in either eye
- •Has a history of not achieving comfortable Contact Lens (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
结局指标
主要结局
Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses
时间窗: 4 weeks
Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses
时间窗: 4 weeks
Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Contact Lenses
时间窗: 4 weeks
Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses
时间窗: 4 weeks
Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses
时间窗: 4 weeks
Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Lens Tightness Assessment by the Investigator - Methafilcon A Contact Lenses
时间窗: 4 weeks
Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).
Post-blink Movement Assessment by the Investigator - Methafilcon A Contact Lenses
时间窗: 4 weeks
Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses
时间窗: 4 weeks
Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).
Overall Lens Fit Acceptance by the Investigator - Methafilcon A Contact Lenses
时间窗: 4 weeks
Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect
Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses
时间窗: 4 weeks
Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect
次要结局
- Average Daily Wearing Time - Methafilcon A Contact Lenses(4 weeks)
- Average Comfortable Wearing Time - Fanfilcon A Contact Lenses(4 weeks)
- Average Daily Wearing Time - Fanfilcon A Contact Lenses(4 weeks)
- Average Comfortable Wearing Time - Methafilcon A Contact Lenses(4 weeks)