A Phase 1/2. Multicenter, Randomized, Double-blinded, Placebo and Active-controlled, Parallel Study for Comparing Efficacy and Safety of TJO-083 in Dry Eye Disease Patients
试验速览
- 阶段
- 1 期
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Evaluate the safety and tolerability of TJO-083 to use questionnaire [Part1]
研究概览
简要总结
This is a prospective randomized study compared with active control and placebo arms.
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
- Quadruple (Participant, Care Provider, 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
- •Patient who have been diagnosed with dry eye syndrome at least 6 months ago
- •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 months the patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease)
- •Intraocular pressure(IOP)> 21 mmHg
研究组 & 干预措施
TJO-083 [Part 2]
1 drop 3 times a day
干预措施: TJO-083 (Drug)
Placebo of TJO-083 [Part 2]
1 drop 6 times a day
干预措施: Placebo (vehicle) (Other)
Diquas-s Ophthalmic solution 3% 0.4mL [Part 2]
1 drop 6 times a day
干预措施: Diquafosol ophthalmic sodium solution 3% (Drug)
结局指标
主要结局
Evaluate the safety and tolerability of TJO-083 to use questionnaire [Part1]
时间窗: Baseline and Day 2, 8
Changes from Baseline in tolerability questionnaire in 4 point scale at Day 2, 8. The including lists are below. Stinging/Burning, Itching, Blurred vision, Sandiness/Grittiness, Dryness, Light sensitivity, Pain or soreness, Hyperemia.
Change From Baseline in Corneal Staining in 9 point Score at Week 4 [Part 2]
时间窗: Baseline and Week 4
Change from Baseline in corneal staining of the worse eye using blue fluorescein staining procedure in 9 point scare at Week 4. (As the score high, the condition of eye is worse)
次要结局
- Change From Baseline in Non-anesthetic Schirmer Test at Week 2, 4, 8, 12 [Part 2](Baseline and Week 2, 4, 8 and 12)