RECRUITINGEarly Phase 1INTERVENTIONAL

JN002 for the Treatment of Dry Eye Disease

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

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

Placebo Ophthalmic Solution (Vehicle)

Placebo ophthalmic solution (vehicle without active ingredient JN002), administered three times daily (1 drop per eye per dose) for 28 ± 2 consecutive days

DRUG

JN002 Ophthalmic Solution (0.05 mg/mL)

JN002 Ophthalmic Solution at a concentration of 0.05 mg/mL, administered three times daily (1 drop per eye per dose) for 28 ± 2 consecutive days

DRUG

JN002 Ophthalmic Solution (0.1 mg/mL)

JN002 Ophthalmic Solution at a concentration of 0.1 mg/mL, administered three times daily (1 drop per eye per dose) for 28 ± 2 consecutive days

Locations (1)

Eye & ENT Hospital of Fudan University

Shanghai, China