Bilateral Dispensing Clinical Trial of Stenfilcon A Against Etafilcon A for Astigmatism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 4
- 主要终点
- Comfort
研究概览
简要总结
Bilateral dispensing clinical trial of stenfilcon A against etafilcon A for astigmatism.
详细描述
CooperVision is evaluating the clinical performance of an FDA cleared silicone-hydrogel lens material stenfilcon A (test) compared to etafilcon A for Astigmatism lens (control) when worn on a daily wear basis over one (1) week in a randomized, bilateral, cross-over, dispensing study.
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
- None
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is at least 17 years of age for Canada and 18 years of age for the USA and has full legal capacity to volunteer;
- •Has read and signed an information consent letter;
- •Is willing and able to follow instructions and maintain the appointment schedule;
- •Is an adapted soft contact lens wearer;
- •Requires a spherical contact lens prescription between -1.00 to -6.00 inclusive in each eye
- •Has spectacle astigmatism: -0.50 to -1.50D (Diopter) cylinder (Axis: 90±20, 180±20 in both eyes);
- •Willing to wear contact lens in both eyes for at least 8 hours per day, 7 days per week;
- •Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye;
- •To be eligible for lens dispensing, the subject must have VA of logMAR equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit as acceptable.
排除标准
- •Is participating in any concurrent clinical or research study;
- •Has any known active* ocular disease and/or infection;
- •Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- •Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- •Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- •Is pregnant, lactating (by verbal confirmation at the screening visit);
- •Is aphakic;
- •Has undergone refractive error surgery
研究组 & 干预措施
stenfilcon A toric lens
Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.
干预措施: stenfilcon A toric lens (Device)
etafilcon A toric lens
Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.
干预措施: etafilcon A toric lens (Device)
结局指标
主要结局
Comfort
时间窗: Baseline and 1 Week
Subjective ratings of lens performance for comfort assessed at baseline and 1 week. Comfort Scale 0-100, 0=extremely uncomfortable/cannot tolerate, 100=extremely comfortable/cannot be felt.
Handling
时间窗: Baseline and 1 Week
Subjective ratings of lens performance for handling assessed at baseline and 1 week. Handling Scale 0-100, 0=very difficult to handle, 100=very easy to handle.
Vision
时间窗: Baseline and 1 Week
Subjective ratings of lens performance for vision assessed at baseline and 1 week. Scale 0-100, 0=extremely poor vision all of the time, cannot function, 100=excellent.
High Visual Acuity
时间窗: Baseline and 1 Week
High illumination high contrast (HIHC) visual acuity for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Visual acuity is measured by logMAR.
Low Visual Acuity
时间窗: Baseline and 1 Week
Low illumination high contrast (LIHC) visual acuity for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Visual acuity is measured by logMAR.
Lens Surface - Wettability
时间窗: Baseline and 1 Week
Lens surface of wettability for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=severely reduced, 4=excellent wettability.
Lens Surface - Deposits
时间窗: Baseline and 1 Week
Lens surface of wettability for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=no deposits, 4=severe deposits.
Corneal Staining, Extent
时间窗: Baseline and 1 week
Ocular health of corneal staining (extent) for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=No staining 1=1-15% of area 2=16-30% of area 3=31-45% of area 4=\>45% of area Five quadrants: C - Central, N - Nasal, T - Temporal, S - Superior, I - Inferior
Corneal Staining, Type
时间窗: Baseline and 1 week
Ocular health of corneal staining, type for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=No staining, 4=Severe staining Five quadrants: C - Central, N - Nasal, T - Temporal, S - Superior, I - Inferior
Conjunctival Staining
时间窗: Baseline and 1 week
Ocular health of conjunctival staining for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Measured in 0.50 steps, scale 0-4, 0=None, 1=Minimal diffuse punctate, 2=Coalescent punctate, 3=Confluent, 4= Deep confluent N - Nasal, T - Temporal, S - Superior, I - Inferior
Lens Durability
时间窗: 1 Week
Lens durability (lens tearing) between stenfilcon A toric lens or etafilcon A toric lens assessed at 1 week. (The number of lens tear or lens nicks found during the one week study).
Lens Fit Acceptance
时间窗: Baseline and 1 Week
Lens fit acceptance (on eye stability) for stenfilcon A and etafilcon A assessed at baseline and 1 week. Scale 0-4, 0=Can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.
次要结局
- Overall Satisfaction(Baseline and 1 week)
- Dryness(1 Week)