Prospective, Randomized Multi-Center Study of Using the Hyper-CL™ Lens in Subjects Suffering From Bacterial Keratitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Change in Bacterial Keratitis severity score
研究概览
简要总结
This study is a prospective, randomized, open-label, two arms, clinical study aim to evaluate the efficacy and safety of treatment with Hyper-CL™ lens + Antibiotics compared with treatment with Antibiotics only, in subjects with Bacterial keratitis.
The design of the Hyper-CL™ lens increases contact time of the antibiotics on the cornea enabling increased bioavailability of the active drug.
详细描述
The Hyper-CL™ Therapeutic soft contact lenses for short-term wear (up to 7 days) are indicated for therapeutic use to promote corneal healing and relieve corneal pain by protecting the cornea during the treatment of acute or chronic pathologies, such as corneal edema, corneal erosions, entropion, bullous keratopathy, and corneal dystrophies as well as post-surgical conditions resulting from cataract extraction and corneal surgery.
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
- None
入排标准
- 年龄范围
- 18 Years 至 86 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 18-86 years old
- •Subject with Bacterial keratitis in one eye only
- •Subject with Bacterial Keratitis of at least grade 2 score in Average length of infiltration and in Average length of epithelial defect (1mm or above)
- •Best-corrected visual acuity of 6/60 or better in the uninvolved eye
- •No prior antibiotic treatment for current Bacterial Keratitis
- •Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
排除标准
- •Perforation or imminent perforation of cornea
- •Subject with glaucoma shunts (e.g. Ahmed valve) and or bleb
- •Sign of inflammation in both eyes
- •Severe itching suggesting viral infection or allergy reaction
- •Subepithelial infiltrate suggesting viral infection
- •Dendrite like ulcer or suspecting of Herpes keratitis
- •Previous penetrating keratoplasty
- •No light perception in the affected eye
- •Other active ocular infection
- •Any infiltration suggesting other than bacterial infection e.g. parasite, fungal
- •Any corneal transplant
- •Post refractive surgery
- •Corneal inlays
- •Any other condition which in the opinion of the investigator would place the patient at undue risk for participation.
- •Participation in another clinical study within the past 30 days
结局指标
主要结局
Change in Bacterial Keratitis severity score
时间窗: From date of randomization up to 14 days
Will be measured by Bacterial keratitis severity score (0-5). A low score is considered an improvement, a high score is considered worsening.
次要结局
未报告次要终点