Combination Therapy of Vevye and Flarex for Dry Eye Disease
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- VAS
研究概览
简要总结
This study evaluates the safety and efficacy of combination therapy with Vevye (cyclosporine ophthalmic solution) and Flarex (fluorometholone acetate ophthalmic suspension) in adults with moderate to severe dry eye disease. Participants receive Vevye twice daily and Flarex four times daily, with outcomes assessed over a 1-month period.
详细描述
Dry eye disease is a multifactorial disorder characterized by inflammation and tear film instability. Vevye is a cyclosporine formulation designed to enhance ocular surface penetration and tolerability. Flarex is a corticosteroid with a lower risk of intraocular pressure elevation compared to traditional steroids. Combination therapy may accelerate symptom relief and improve tear film stability.
This prospective, open-label, single-arm study evaluates the clinical outcomes of BID Vevye and QID Flarex over multiple visits, including Screening, Baseline, Day 3, Week 1, and Month 1. Both eyes are treated, with the study eye defined by the worse baseline VAS score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Adults ≥18 years VAS ≥30 mm (moderate-severe dry eye) Able to provide informed consent Women of childbearing potential must meet contraception requirements
排除标准
- •Uncontrolled systemic disease Ocular surgery/trauma within 12 months Punctal plugs <6 months Active ocular infection/inflammation Recent lid heating therapy (<6 months) Pregnant or breastfeeding Use of topical ocular meds after screening Significant corneal disease Systemic meds causing dry eye (e.g., antihistamines, antidepressants) Intraocular pressure >21 mmHg or glaucoma history Contact lens use within 7 days Substance abuse within 12 months
研究组 & 干预措施
Combination Therapy Arm
Participants receive Vevye (cyclosporine ophthalmic solution) twice daily and Flarex (fluorometholone acetate ophthalmic suspension) four times daily.
干预措施: Vevye(Cyclosporine 0.1% Ophthalmic Solution) (Drug)
Combination Therapy Arm
Participants receive Vevye (cyclosporine ophthalmic solution) twice daily and Flarex (fluorometholone acetate ophthalmic suspension) four times daily.
干预措施: Flarex (Drug)
结局指标
主要结局
VAS
时间窗: Baseline to 1 Month
Change in Visual Analog Scale (VAS) Score
次要结局
未报告次要终点
研究者
Milton Hom
Optometrist
Canyon City Eyecare