Randomized, Double-Blind, Placebo-Controlled, Single Center Clinical Trial to Evaluate the Safety and Preliminary Efficacy of JN002 Ophthalmic Solution in Adult Patients With Dry Eye Disease
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Corneal Fluorescein Staining score
研究概览
简要总结
This is a first-in-human, single-center, randomized, double-blind, placebo-controlled clinical trial designed to:·Evaluate the efficacy of JN002 Ophthalmic Solution in treating dry eye disease (DED)·Assess the safety of JN002 Ophthalmic SolutionResearchers will compare three groups-placebo (vehicle), low-dose JN002 (0.05 mg/mL), and high-dose JN002 (0.1 mg/mL)-to evaluate whether JN002 Ophthalmic Solution improves DED outcomes and to assess its safety profile relative to placebo.Participants will:·Complete a baseline assessment (V0) including ocular exams, OSDI questionnaire, and systemic evaluation;·Administer the assigned study medication three times daily (1 drop per eye per administration);·Attend three follow-up visits (V1: 7±2 days, V2: 14±2 days, V3: 28±2 days post-treatment initiation) for ocular assessments, symptom queries, and adherence checks;·Undergo a full repeat of baseline assessments at V3 to evaluate treatment effects and safety profile
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older
- •Ocular Surface Disease Index (OSDI) score ≥ 13
- •Schirmer I test result ≤ 10 mm/5 min
- •Fluorescein tear film break-up time < 10 seconds
- •Corneal Fluorescein Staining score (National Eye Institute grading) ≥ 4
- •Best corrected visual acuity ≥ 0.6
- •Intraocular pressure ≤ 21 mmHg
- •Voluntarily agrees to participate in the study
排除标准
- •History of refractive surgery or intraocular surgery within the past 6 months
- •Clinically relevant ocular abnormalities at screening or baseline, including but not restricted to eye trauma, pterygium, allergic keratoconjunctivitis, active ocular infections, or abnormal ocular structures
- •Uncontrolled ocular or systemic diseases
- •Other conditions deemed by the investigators likely to interfere with study parameters
- •Females with plans for pregnancy at enrollment or during the treatment period
研究组 & 干预措施
Placebo Group
Placebo ophthalmic solution
干预措施: Placebo Ophthalmic Solution (Vehicle) (Drug)
Low-Dose JN002 Group
JN002 Ophthalmic Solution at a concentration of 0.05 mg/mL
干预措施: JN002 Ophthalmic Solution (0.05 mg/mL) (Drug)
High-Dose JN002 Group
JN002 Ophthalmic Solution at a concentration of 0.1 mg/mL
干预措施: JN002 Ophthalmic Solution (0.1 mg/mL) (Drug)
结局指标
主要结局
Corneal Fluorescein Staining score
时间窗: Baseline, 7±2 days, 14±2 days and 28 ± 2 days
Change from baseline in Corneal Fluorescein Staining (CFS) score at the 7±2 days, 14±2 days and 28±2 days follow-up. CFS is evaluated following the guidelines from the National Eye Institute: the corneal surface is divided into five regions (central, superior, inferior, nasal, temporal), with each region assigned a score ranging from 0 to 3, resulting in a total possible score of 0 to 15-higher scores indicate more severe corneal epithelial damage and a worse clinical outcome.
Ocular Surface Disease Index score
时间窗: Baseline, 7±2 days, 14±2 days and 28±2 days
Change from baseline in Ocular Surface Disease Index (OSDI) score at the 7±2 days, 14±2 days and 28±2 days follow-up. OSDI is assessed via a 12-item self-reported questionnaire, where raw scores are converted to a standardized 0-100 scale through a specific calculation, with higher scores indicating more severe ocular surface disease symptoms.
次要结局
- Tear inflammatory cytokines(Baseline and 28 ± 2 days)
- Schirmer I test(Baseline and 28 ± 2 days)
- Tear meniscus height(Baseline and 28 ± 2 days)
- Non-invasive tear film break-up time(Baseline and 28 ± 2 days)