Kera Sol Post-LASIK: A Benefit Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Baseline of Corneal Staining
研究概览
简要总结
Collecting data using Kera Sol tear usage during the initial two-week post-operative period after Laser-Assisted In Situ Keratomileusis (LASIK) has on the signs and symptoms of surgical temporary ocular discomfort syndrome (STODS)
详细描述
Prospective, single-site, two-arm randomized study evaluating the impact of, Kera Sol tears on the signs and symptoms of STODS in 60 patients who underwent bilateral LASIK. Both groups will be prescribed the standard of care post-operative prescription combination steroid and antibiotic drop. Additionally, subjects will be randomized to administer the study drop (Kera Sol) dosed QID for 14 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 是
入选标准
- •Be willing and able to sign the informed consent form (ICF)
- •Be at least 18 years of age at the screening visit
- •Be undergoing LASIK treatment in both eyes
- •Be literate and able to complete questionnaires independently
- •Be able and willing to use the study drug and participate in all study assessments and visits
- •Have provided verbal and written informed consent
排除标准
- •Use of topical prescription dry eye medications such as lifitegrast, cyclosporine, loltilaner, etc.
- •Have a break in the integrity of the corneal epithelium such as a persistent corneal epithelial defect, or corneal ulcer.
- •Have presence of corneal pathology that may interfere with LASIK outcomes
- •Active infectious, ocular or systemic disease
- •Have a history of ocular inflammation or macular edema
- •Have had clinically significant active infectious keratitis in the past 3 months
- •Have history of prior refractive surgery
- •Have placement of temporary punctal plugs in the past 1 month or current presence of permanent punctal plugs at time of screening
- •Patients with usual relative and absolute contraindications for LASIK surgery (Patients with severe dry eye, recurrent corneal erosion, uncontrolled Glaucoma, collagen vascular disorders, keratoconus or signs of keratoconus, uncontrolled Diabetes, Herpes)
- •Autoimmune or immunodeficiency diseases
- •Pregnant or nursing women
- •Patients with history of previous ocular surgery, , except for previous cataract surgery.
研究组 & 干预措施
Kera Sol
Subjects will be randomized to administer the study drop (Kera Sol) dosed QID for 14 days.
干预措施: Kera Sol Eye Drops (Drug)
Standard of Care
No Kera Sol drops
结局指标
主要结局
Change in Baseline of Corneal Staining
时间窗: 14 days
Using the National Eye Institute (NEI) scale system. The NEI scale system for grading fluorescein staining divides the corneal and conjunctival surfaces. The conjunctival surface is divided into 6 areas and the corneal surface is divided into 5 areas. A standardized grading system of 0 to 3 is used for each of areas on cornea and conjunctiva. The maximum staining score for the cornea is 15, and for conjunctiva, the maximum score is 18. The values above 3 is considered abnormal for cornea or conjunctiva in each eye. Grade 0 (i.e., no staining) indicates normal cornea or normal conjunctiva Grade 3 (i.e., highest severity staining) indicates severe ocular surface damage NEI Scale ranges from 0-4. Grade 0 = no dots; Grade 1 = 1-15 dots; Grade 2 = 16-30 dots, and Grade 3 = 31 or \> dots.
次要结局
未报告次要终点