Mucin Balls and Corneal Inflammation Events
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 289
- 试验地点
- 3
- 主要终点
- Corneal Infiltrate Event- Phase II
研究概览
简要总结
The purpose of this study is to determine if the formation of mucin balls is a marker for protection from inflammatory events to the cornea and if mucin balls play a role in protection during extended contact lens wear.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years
- •Free of any active anterior segment disorders that would preclude safe contact lens wear. Active anterior segment disorders and evidence of central microbial keratitis (via a large, >1mm central deep stromal scar) are not allowed. However, evidence of past Contact Lens-Induces Peripheral Ulcer (CLPU) will be allowed so long as no more then three such scars are detected bilaterally. Evidence of more than 3 CLPU-like scars places excessive risk on the subject for a subsequent Corneal Infiltrate Event (CIE).
- •Correctable vision to 20/25 or better in each eye with spectacles. Amblyopia will be excluded.
- •Flat and steep corneal curvatures from keratometry readings must be between 39.00 and 48.50 D, respectively.
- •Own or agree to purchase a pair of spectacles that can be worn when lenses are removed or in cases of ocular discomfort or emergency.
- •Correctable vision to 20/30 or better at distance with dispensed contact lenses.
排除标准
- •Use/wear of rigid gas permeable lenses within the last 30 days or Poly (methyl methacrylate) (PMMA) lenses within the last 3 months.
- •Immunocompromising disease or insulin dependent diabetes or any other systemic disease that in the investigator's opinion will affect ocular health or increase risk during extended wear.
- •Chronic use of systemic corticosteroids (with the exception of corticosteroid inhalers) or any other medication that in the investigator's opinion will affect ocular physiology or study participation.
- •Ocular disease or condition such as aphakia, corneal dystrophies, corneal edema, external ocular infection, iritis, or had any anterior segment surgery.
- •Use of any ocular medications in the last 2 weeks.
- •Less than or equal to grade 2 on any of the slit lamp observations of: upper tarsal papilla, corneal staining, corneal neovascularization, conjunctival injection, and lid erythema or scales.
- •Currently pregnant or lactating.
- •Swimming routine of more than twice per month.
研究组 & 干预措施
lotrafilcon A, comfilcon A
All subjects are assigned to lotrafilcon A during a run-in (Phase 1) and then randomized to one of two lenses. This arm is assigned to comfilcon A at phase 2. Subjects classified as a Neophyte wore etafilcon A for 2-weeks before entering the run-in period in Phase I.
干预措施: lotrafilcon A (Device)
lotrafilcon A, comfilcon A
All subjects are assigned to lotrafilcon A during a run-in (Phase 1) and then randomized to one of two lenses. This arm is assigned to comfilcon A at phase 2. Subjects classified as a Neophyte wore etafilcon A for 2-weeks before entering the run-in period in Phase I.
干预措施: comfilcon A (Device)
lotrafilcon A, comfilcon A
All subjects are assigned to lotrafilcon A during a run-in (Phase 1) and then randomized to one of two lenses. This arm is assigned to comfilcon A at phase 2. Subjects classified as a Neophyte wore etafilcon A for 2-weeks before entering the run-in period in Phase I.
干预措施: etafilcon A (Other)
lotrafilcon A, balafilcon A
All subjects are assigned to lotrafilcon A during a run-in (Phase 1) and then randomized to one of two lenses. This arm is assigned to balafilcon A at phase 2. Subjects classified as a Neophyte wore etafilcon A for 2-weeks before entering the run-in period in Phase I.
干预措施: lotrafilcon A (Device)
lotrafilcon A, balafilcon A
All subjects are assigned to lotrafilcon A during a run-in (Phase 1) and then randomized to one of two lenses. This arm is assigned to balafilcon A at phase 2. Subjects classified as a Neophyte wore etafilcon A for 2-weeks before entering the run-in period in Phase I.
干预措施: balafilcon A (Device)
lotrafilcon A, balafilcon A
All subjects are assigned to lotrafilcon A during a run-in (Phase 1) and then randomized to one of two lenses. This arm is assigned to balafilcon A at phase 2. Subjects classified as a Neophyte wore etafilcon A for 2-weeks before entering the run-in period in Phase I.
干预措施: etafilcon A (Other)
结局指标
主要结局
Corneal Infiltrate Event- Phase II
时间窗: 12-Month Follow-up
The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification.
Corneal Infiltrate Events - Phase I
时间窗: 1-Month Follow-up
The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification.
次要结局
未报告次要终点