A Comparative study of Chloroquine Cyclosporine and Lifitegrast in the management of Dry eye Disease-Clarity Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Tear Breakup Time Improvement from baseline to 12 weeks
研究概览
简要总结
The CLARITY trial is a randomized double blind parallel group active controlled clinical trial designed to compare the efficacy and safety of three topical anti inflammatory agents chloroquine 003 percent lifitegrast 5 percent and cyclosporine 005 percent in the treatment of moderate to severe dry eye disease DED A total of 225 participants 75 per group will be enrolled and followed for 12 weeks at a single tertiary care center in Odisha India Primary outcomes include changes in Tear Break Up Time TBUT and Ocular Surface Disease Index OSDI scores from baseline to week 12 Secondary outcomes include Schirmers test corneal and conjunctival staining and patient reported quality of life measures This study aims to provide comparative data to guide the selection of anti inflammatory agents for managing moderate to severe DED including evaluation of the emerging role of topical chloroquine
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed dry eye based on OSDI score lesser than 13 and TBUT lesser than 10 sec Schirmer test lesser than 10 mm without anesthesia Willing to provide informed consent and comply with study procedures.
排除标准
- •Presence of ocular surface diseases that might interfere with dry eye assessment example severe blepharitis active ocular infections, allergic conjunctivitis History of ocular surgery in the past 6 months Use of systemic medications affecting tear production or ocular surface Known hypersensitivity or contraindication to chloroquine, lifitegrast, or cyclosporine Pregnant or breastfeeding women Any systemic illness.
结局指标
主要结局
Tear Breakup Time Improvement from baseline to 12 weeks
时间窗: Tear Breakup Time Improvement from baseline to 12 weeks | Ocular Surface Disease Index Score Change from baseline to 12 weeks
Ocular Surface Disease Index Score Change from baseline to 12 weeks
时间窗: Tear Breakup Time Improvement from baseline to 12 weeks | Ocular Surface Disease Index Score Change from baseline to 12 weeks
次要结局
- Schirmer’s Test (without anesthesia): Tear production(Corneal and conjunctival staining (fluorescein and lissamine green): Ocular surface assessment)
研究者
SHWETA DHIMAN
JPM ROTARY EYE HOSPITAL AND RESEARCH INSTITUTE