A Randomized, Masked (Reading Center), Prospective Pilot Study of the Safety and Effectiveness of the EyeGate Ocular Bandage Gel, a 0.75% Crosslinked Hyaluronic Acid Applied Topically, Versus a Bandage Contact Lens for Acceleration of Re-epithelialization of Large Corneal Epithelial Defects in Patients Having Undergone Photorefractive Keratectomy (PRK).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Time to corneal re-epithelization post PRK
研究概览
简要总结
This is a prospective, randomized (Reading Center), masked, controlled study in up to 45 subjects who have undergone bilateral PRK with epithelial removal using alcohol in a 9.0 mm well or trephine at the time of surgery to ensure consistency of the size of the ablation area.
详细描述
This is a prospective, randomized (Reading Center), masked, controlled study in up to 45 subjects who have undergone bilateral PRK with epithelial removal using alcohol in a 9.0 mm well or trephine at the time of surgery to ensure consistency of the size of the ablation area. Subjects will be assigned to one of three treatment arms on Day 0.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Used a masked reading center to review the corneal defect staining.
入排标准
- 年龄范围
- 22 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to comply with the protocol
排除标准
- 未提供
研究组 & 干预措施
Treatment 1
Ocular Bandage Gel
干预措施: Ocular Bandage Gel (Device)
Control Group
Artificial tears with Acuvue Oasys
干预措施: Acuvue Oasys (Device)
Control Group
Artificial tears with Acuvue Oasys
干预措施: Ocular Bandage Gel (Device)
Treatment 2
Ocular Bandage Gel
干预措施: Ocular Bandage Gel (Device)
结局指标
主要结局
Time to corneal re-epithelization post PRK
时间窗: Day 3
Time to corneal re-epithelization post PRK
次要结局
未报告次要终点