Comparison of Therapeutic Effects of Once-daily Fluorometholone 0.1% Versus Twice-daily Cyclosporine 0.05% in Patients with Dry Eye Disease: a Randomized, Assessor-blinded Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Ocular Surface Disease Index (OSDI) score
研究概览
简要总结
This study compares the therapeutic effects of once-daily fluorometholone 0.1% versus twice-daily cyclosporine 0.05% after short-term fluorometholone induction treatment in dry eye disease.
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)
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
- •participants aged 18 years or older
- •complaint of dry eye symptoms for 6 months or longer at screening
- •ocular surface disease index (OSDI) score of 33 or higher
- •tear film breakup time of 7 seconds or less
排除标准
- •abnormal lid anatomy or active blepharitis
- •severe systemic autoimmune diseases
- •received permanent lacrimal plug within 3 months
- •DED secondary to alkali burns, cicatricial pemphigoid, or Stevens-Johnson syndrome
- •ocular/periocular malignancy
- •active ocular allergies or allergy to the study drug or its components
- •active infection
- •intraocular surgery or ocular laser surgery within 6 months
- •uncontrolled systemic disease or history of herpetic keratitis
- •contact lens user
- •intraocular pressure >25mmHg
- •pregnancy or current breast-feeding.
研究组 & 干预措施
once-daily fluorometholone 0.1% group
After induction therapy with fluorometholone 0.1% four times a day for 4 weeks, patients continued with fluorometholone 0.1% once a day for 8 weeks.
干预措施: Fluorometholone 0.1% ophthalmic solution (Drug)
twice-daily cyclosporine 0.05% group
After induction therapy with fluorometholone 0.1% four times a day for 4 weeks, patients continued with cyclosporine 0.05% twice a day for 8 weeks.
干预措施: Cyclosporine 0.05% eye drops (Drug)
结局指标
主要结局
Ocular Surface Disease Index (OSDI) score
时间窗: From enrollment to the end of treatment at 12 weeks
Score 0-100
tear breakup time (TBUT)
时间窗: From enrollment to the end of treatment at 12 weeks
Unit: Seconds
corneal staining score (CSS)
时间窗: From enrollment to the end of treatment at 12 weeks
National Eye Institute Scale, 0-15
Schirmer's test
时间窗: From enrollment to the end of treatment at 12 weeks
Unit: mm/5 min
Meibomian gland dysfunction grade (0-4)
时间窗: From enrollment to the end of treatment at 12 weeks
Scale 0-4
tear matrix metalloproteinase-9 (MMP-9) grade
时间窗: From enrollment to the end of treatment at 12 weeks
Grade 0-4
tear osmolarity
时间窗: From enrollment to the end of treatment at 12 weeks
Unit: mOsm/L
次要结局
- Tear IL-6 levels(From enrollment to the end of treatment at 12 weeks)
- tear 8-oxo-dG levels(From enrollment to the end of treatment at 12 weeks)
研究者
Dong Hyun Kim
Principal Investigator
Korea University Anam Hospital