Actively Recruiting
JN002 for the Treatment of Dry Eye Disease
Led by Eye & ENT Hospital of Fudan University · Updated on 2025-12-01
30
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
JN002 for the Treatment of Dry Eye Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Ocular Surface Disease Index (OSDI) score 13 or higher
- Schirmer I test result 10 mm or less in 5 minutes
- Fluorescein tear film break-up time less than 10 seconds
- Corneal Fluorescein Staining score 4 or higher (National Eye Institute grading)
- Best corrected visual acuity of 0.6 or better
- Intraocular pressure of 21 mmHg or less
- Voluntarily agrees to participate in the study
You will not qualify if you...
- History of refractive surgery or intraocular surgery within the past 6 months
- Clinically relevant ocular abnormalities at screening or baseline, including eye trauma, pterygium, allergic keratoconjunctivitis, active ocular infections, or abnormal ocular structures
- Uncontrolled ocular or systemic diseases
- Other conditions likely to interfere with study parameters as judged by investigators
- Females planning pregnancy at enrollment or during the treatment period
AI-Screening
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Trial Site Locations
Total: 1 location
1
Eye & ENT Hospital of Fudan University
Shanghai, China
Actively Recruiting
Research Team
J
Jiaxu Hong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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