ACTRN12623001230640招募中2 期
A Multicenter, Randomized, Controlled, Double-Masked, Phase 2 Trial of the Safety and Therapeutic Effects of ILYX-002 Versus Vehicle Control for Treatment of Dry-Eye Disease in Patients with Autoimmune Disease
Iolyx Australia Pty Ltd.0 个研究点目标入组 110 人开始时间: 2023年11月30日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 85 Years（—）
- 性别
- All
入选标准
- •1. Male or Female >=18 and <=85 years
- •2. History of autoimmune disease
- •3. BCVA of 20/100 or better in trial eye
- •4. Moderate to severe Dry Eye Disease
- •5.. Use of artificial tears at least 2 times per days for at least 30 days prior to screening
排除标准
- •1. Known hypersensitivity or contraindications to the trial treatment or its components
- •2. Within 30 days prior to screening have taken contraindicated medications or investigational treatments
- •3. Contact lens use during the trial
- •4. Ocular surface or anterior segment surgery within 12 months of screening
- •5. Change in dose or frequency within 90 days prior to screening, or anticipated during trial, of chronic medications
- •6. History of uncontrolled glaucoma or actively being treated for glaucoma
- •7. History of punctal cautery
- •8. Current use of punctal plugs
- •9. Hepatic insufficiency
- •10. Currently pregnant or lactating.
研究者
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