NCT04384991已完成3 期
A Multicenter, Randomized, Double Blind, Restasis-controlled Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of HU007 Eye Drops in Patients With Dry Eye Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Change from baseline in corneal staining score-Oxford grading
研究概览
简要总结
This study is a multicenter, randomized, double blind, Restasis-controlled non-inferiority, Phase III Study to evaluate the efficacy and safety of HU007 eye drops in patients With 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female who over 19 years old
- •Those who meet below criteria at least one of two eyes
- •Those who have over than score 2 in corneal staining test-Oxford grading
- •Tear secretion test without anesthesia(Schirmer test) result would be under 10mm/5min (If the test result is 0mm/5min, it should be over than 3mm/5min on the nasal stimulation schirmer test in the same eye)
- •TBUT(Tear film break-up time) test result should be under 10sec.
- •Woman with no possibility of pregnancy or negative pregnancy test results at a screening visit, Women or men who have agreed to maintain at least one contraceptive method during study period
- •Those who could understand this study and agree to informed consent voluntarily
排除标准
- •Those who have clinically significant eye disease not related to dry eye symdrome
- •Those who are in anti-inflammatory medication for dry eye syndrome
- •Medication of systemic steroid or immunosuppressant
- •Those who have worn contact lenses before 72hours or have to wear contact lenses or disagree not to wear contact lenses during study period
- •Those who have medical history with intraocular surgery 90 days before screening visit
- •Those who have any active ophthalmic diseases such as active allergy, anterior uveitis, stevens-johnson syndrom which could affect the surfece of eye
- •Those who have any autoimmune diseases
- •Those who need a surgery for surface elevation caused by meibomian gland dysfunction(MGD)
- •Those who have any medical history of corneal transplantation or neurotrophic keratitis
- •Those who have diagnosed with glaucoma or have an intraocular pressure over than 25mmHg at least in one of the eyes
- •Those who have medicated cyclosporine or steroid eye-drops 30 days before screening visit
- •Those who have underwent any eye correction surgery such as LASIK(Laser-assistant in situ keratomileusis) 12 months before screening visit
- •Those who have underwent a silicone lacrimal punctal occlusion or cauterization of the punctum excluding collagen lacrimal punctal occlusion 90 days before screening visit
- •Those who have a hypersensitivity reaction for cyclosporine, trehalose or protein-based medication related to investigational drug
- •Those who have diagnosed a psychical disorder which could affect this study
- •Women who is pregnant or breastfeeding or those who have a plan to be pregnant
- •Those who have medical history on abusing medications or alchol
- •Those who have received other investigational drugs/devices 30 days before screening visit
- •Those who are inappropriate for participating in this study according to investigator's judgement
研究组 & 干预措施
Restasis Eye drop 0.05% (Cyclosporine)
Active Comparator
Adminster twice a day(one drop would be administered to both eyes once a time). When being administered, the IP should be mixed by upside down.
Medication is recommended at 9AM(±1H) and 9PM(±1H)
干预措施: Restasis eye drop (Drug)
HU007 Eye drop
Experimental
Adminster twice a day(one drop would be administered to both eyes once a time). When being administered, the IP should be mixed by upside down.
Medication is recommended at 9AM(±1H) and 9PM(±1H)
干预措施: HU007 (Drug)
结局指标
主要结局
Change from baseline in corneal staining score-Oxford grading
时间窗: Week 12
Change from baseline in corneal staining score-Oxford grading at Week 12
次要结局
- Change from baseline in corneal staining score-Oxford grading(Week 4, 8)
- Change from baseline in conjunctival staining score-Oxford grading(Week 4, 8, 12)
- Change from baseline in strip meniscometry(Week 4, 8, 12)
- Change from baseline in Tear film break-up time(at Week 4, 8, 12)
- Change from Baseline of Standard patient evaluation of eye dryness questionnaire(at Week 4, 8, 12)
- Time to achieve 100% clearance on the corneal staining score(upto week 12)
研究者
研究点 (1)
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