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JN002 for the Treatment of Dry Eye Disease

RecruitingEARLY Phase 1Ages 18 Years - anyAllEye & ENT Hospital of Fudan University
NCT07245017 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 baselin

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Aged 18 years or older 2. Ocular Surface Disease Index (OSDI) score ≥ 13 3. Schirmer I test result ≤ 10 mm/5 min 4. Fluorescein tear film break-up time \< 10 seconds 5. Corneal Fluorescein Staining score (National Eye Institute grading) ≥ 4 6. Best corrected visual acuity ≥ 0.6 7. Intraocular pressure ≤ 21 mmHg 8. Voluntarily agrees to participate in the study Exclusion Criteria: 1. History of refractive surgery or intraocular surgery within the past 6 months 2. 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 3. Uncontrolled ocular or systemic diseases 4. Other conditions deemed by the investigators likely to interfere with study parameters 5. Females with plans for pregnancy at enrollment or during the treatment period
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What it tests

  • Placebo Ophthalmic Solution (Vehicle)
  • JN002 Ophthalmic Solution (0.05 mg/mL)
  • JN002 Ophthalmic Solution (0.1 mg/mL)
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Where

1 site
Eye & ENT Hospital of Fudan University
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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