Daytime Corneal Swelling During Wear of Narafilcon B Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Corneal Thickness
研究概览
简要总结
The purpose of this research is to measure daytime open-eye response to wearing of narafilcon B lenses.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be of legal age (i.e. ≥ 18 years).
- •Be mentally competent, willing and able to sign a written informed consent form.
- •Have contact lens distance sphere requirement in the range -1.00D to -6.00D.
- •Have spectacle astigmatism <1.25D in each eye.
- •Currently wear soft contact lenses (for at least 6 months prior to the trial) with documentation of current prescription.
- •Have normal eyes with no evidence of abnormality or disease. For the purpose of this study a normal eye is defined as one having: i) no evidence of lid abnormality or infection; ii) no conjunctival abnormality or infection; iii) no clinically significant slit lamp findings (i.e, edema, staining, scarring, vascularization, infiltrates or abnormal opacities); iv) no other active ocular disease.
排除标准
- •Required concurrent ocular medication.
- •Any systemic illness which would contra-indicate lens wear or the medical treatment of which would affect vision or successful lens wear.
- •Eye injury or surgery within eight weeks immediately prior to enrollment for this study.
- •Abnormal lacrimal secretions.
- •Pre-existing ocular irritation that would preclude contact lens fitting.
- •Keratoconus or other corneal irregularity.
- •Pregnancy, lactating or planning a pregnancy at the time of enrollment.
- •Participation in any concurrent clinical trial.
研究组 & 干预措施
Spectacles No Lenses
Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
干预措施: Spectacles (Other)
narafilcon B
Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
干预措施: narafilcon B (Device)
polymacon
Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
干预措施: Polymacon (Device)
lotrafilcon A
Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
干预措施: Lotrafilcon A (Device)
结局指标
主要结局
Corneal Thickness
时间窗: After 8 hours of contact lens wear
Percentage of corneal swelling (positive value) or deswelling (negative value) measured with Haag-Streit pachymetry equipment in microns, reported as a percent.
Endothelial Blebs
时间窗: baseline, after 20 minutes of treatment conditions
Corneal images captured with equipment are measured, manually outlined to estimate total bleb area from 0 to 100%. This is measured as a change in percentage after 20 minutes compared to the value prior to lens wear (baseline).
Limbal Redness
时间窗: Baseline, After 8 hours of treatment conditions
Scale of 0 to 4, where 0=none and 4= severe redness. Measure reported as a comparison of 8 hours of wear to baseline with the difference being reported.
次要结局
- Overall Comfort(after 8 hours)