NCT05245604Unknown3 期
A Phase Ⅲ, Multicenter, Randomized, Double-blind, Active-controlled, Parallel Study of TJO-087 for Evaluating 32 Weeks Safety and Efficacy in Moderate to Severe Dry Eye Disease Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Change From Baseline in Non-anesthetic Schirmer Test at Week 32
研究概览
简要总结
The purpose of this clinical study is to prove that the test drug (TJO-087) is not clinically inferior to the control drug after 32 weeks of administration to patients with suppressed tear production due to moderate or severe dry eye syndrome.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age 20 or over
- •Patients with moderate to severe dry eye
- •Screening both eyes, the corrected visual acuity is 0.2 or more
- •Written informed consent to participate in the trial
排除标准
- •Screening visits within 2 weeks who treated with topical NSAIDs/hyaluronate sodium ophthalmic solutions
- •Screening visits within 2 months the patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease)
- •Intraocular pressure(IOP)> 25 mmHg
- •Patient using or to use punctual plug within 1 months.
- •Patients with contact lens.
研究组 & 干预措施
TJO-087
Experimental
干预措施: TJO-087 (Drug)
Cyclosporine 0.05%
Active Comparator
干预措施: Cyclosporine ophthalmic solution 0.05% (Drug)
结局指标
主要结局
Change From Baseline in Non-anesthetic Schirmer Test at Week 32
时间窗: Baseline and Week 32
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac.
次要结局
- Change From Baseline in Corneal Fluorescein Staining Score at Week 8, 16, 24 and 32(Baseline, Week 8, 16, 24 and 32)
- Change From Baseline in Non-anesthetic Schirmer Test at Week 8, 16, 24(Baseline, Week 8, 16 and 24)
研究者
研究点 (1)
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