PAVES Benchmarking Pilot Study of Daily Disposable Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 6
- 主要终点
- Subjective Lens Preference
研究概览
简要总结
The study will compare the short-term clinical performance and wearer and practitioner acceptability in a pilot study of a new-to-market spherical silicone hydrogel daily disposable soft contact lens (SiHyDD) to three (3) benchmark soft daily disposable lenses (DD) and, subsequently, of a new-to-market hydrogel spherical daily disposable (HydDD) soft contact lens to three (3) other hydrogel daily disposable lenses. .
The primary outcome variables for this study are subjective comfort and lens preference.
详细描述
The objective of the study is to compare the short-term clinical performance and wearer and practitioner acceptability in a pilot study of a new-to-market spherical silicone hydrogel olifilcon B with Tangible Coating daily disposable soft contact lens (SiHyDD) to three (3) benchmark soft daily disposable lenses (DD) and, subsequently, of a new-to-market hydrogel etafilcon A with Tangible Coating spherical daily disposable (HydDD) soft contact lens to three (3) other hydrogel daily disposable lenses. .
The primary outcome variables for this study are subjective comfort and lens preference.
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
- Single (Care Provider)
盲法说明
Clinician masking achieved by clinic coordinator dispensing lenses. Open label to participants.
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy full-time wearers of spherical daily disposable contact lenses
- •Vision correctable to 20/30 with spherical lenses in powers from +3.00 to +1.00 DS and from -1.00 to -7.00 DS
- •Visual acuity corrected to at least 20/30 with spherical contact lens
排除标准
- •Participating in another clinical trial
- •Vision not correctable to 20/30 with lens powers listed above
研究组 & 干预措施
B4 - BioTrue to HydDD
1 week of BIOTRUE ONEday® contact lenses followed by cross over to 1 week of Test HydDD contact lenses.
干预措施: Phase B - etafilcon A with Tangible Coatings (Device)
A3 - SiHyDD to OASDD
1 week of Test SiHyDD contact lenses followed by cross over to 1 week of ACUVUE® OASYS 1-Day contact lenses.
干预措施: Phase A - olifilcon B with Tangible Coatings (Device)
A4 - OASDD to SiHyDD
1 week of ACUVUE® OASYS 1-Day contact lenses followed by cross over to 1 week of Test SiHyDD contact lenses.
干预措施: Phase A - olifilcon B with Tangible Coatings (Device)
A1 - SiHyDD to Moist
1 week of Test SiHyDD contact lenses followed by cross over to 1 week of 1-DAY ACUVUE® Moist contact lenses.
干预措施: Phase A - olifilcon B with Tangible Coatings (Device)
A2 - Moist to SiHyDD
1 week of 1-DAY ACUVUE® Moist contact lenses followed by cross over to 1 week of Test SiHyDD contact lenses.
干预措施: Phase A - olifilcon B with Tangible Coatings (Device)
A5 - SiHyDD to DT1
1 week of Test SiHyDD contact lenses followed by cross over to 1 week of Alcon DAILIES TOTAL 1® contact lenses.
干预措施: Phase A - olifilcon B with Tangible Coatings (Device)
A6 - DT1 to SiHyDD
1 week of Alcon DAILIES TOTAL 1® contact lenses followed by cross over to 1 week of Test SiHyDD contact lenses.
干预措施: Phase A - olifilcon B with Tangible Coatings (Device)
B1 - HydDD to Moist
1 week of Test HydDD contact lenses followed by cross over to 1 week of 1-DAY ACUVUE® Moist contact lenses.
干预措施: Phase B - etafilcon A with Tangible Coatings (Device)
B2 - Moist to HydDD
1 week of 1-DAY ACUVUE® Moist contact lenses followed by cross over to 1 week of Test HydDD contact lenses.
干预措施: Phase B - etafilcon A with Tangible Coatings (Device)
B3 - HydDD to BioTrue
1 week of Test HydDD contact lenses followed by cross over to 1 week of BIOTRUE ONEday® contact lenses.
干预措施: Phase B - etafilcon A with Tangible Coatings (Device)
B5 - HydDD to AqCom+
1 week of Test HydDD contact lenses followed by cross over to 1 week of DAILIES® AquaComfort PLUS® contact lenses.
干预措施: Phase B - etafilcon A with Tangible Coatings (Device)
B6 - AqCom+ to HydDD
1 week of DAILIES® AquaComfort PLUS® contact lenses followed by cross over to 1 week of Test HydDD contact lenses.
干预措施: Phase B - etafilcon A with Tangible Coatings (Device)
结局指标
主要结局
Subjective Lens Preference
时间窗: Visit 3 - Approximately 2 weeks
Subjective preference for either lens intervention or no preference. Likert question with forced preference for Test or Benchmark lens or no preference.
次要结局
- 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) score(Visit 2 and 3 - Approximately 1 and 2 weeks, respectively)