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

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

Study Overview

• Status: Recruiting
• Conditions: Dry Eye
• Intervention / Treatment: Drug: Placebo Ophthalmic Solution (Vehicle); Drug: JN002 Ophthalmic Solution (0.05 mg/mL); Drug: JN002 Ophthalmic Solution (0.1 mg/mL)

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Jiaxu Hong; Phone Number: 021-64377134; Email: Jiaxu.hong@fdeent.org

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Eye & ENT Hospital of Fudan University
    • Contact: Jiaxu Hong; Phone Number: 86 21 64377134; Email: Jiaxu.hong@fdeent.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Group; Placebo ophthalmic solution	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
Experimental: Low-Dose JN002 Group; JN002 Ophthalmic Solution at a concentration of 0.05 mg/mL	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
Experimental: High-Dose JN002 Group; JN002 Ophthalmic Solution at a concentration of 0.1 mg/mL	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal Fluorescein Staining score	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.	Baseline, 7±2 days, 14±2 days and 28 ± 2 days
Ocular Surface Disease Index score	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.	Baseline, 7±2 days, 14±2 days and 28±2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Schirmer I test	Change from baseline in Schirmer I test result (measuring aqueous tear secretion) at the 28±2 days follow-up.	Baseline and 28 ± 2 days
Tear meniscus height	Change from baseline in tear meniscus height at the 28±2 days follow-up.	Baseline and 28 ± 2 days
Non-invasive tear film break-up time	Change from baseline in non-invasive tear film break-up time (measured via Keratograph 5M) at the 28±2 days follow-up.	Baseline and 28 ± 2 days
Tear inflammatory cytokines	Change from baseline in tear inflammatory cytokines (IL-1β, IL-6, IL-17A, TNF-α, INF-γ) levels at the 28±2 days follow-up.	Baseline and 28 ± 2 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal dendritic cell density	Change from baseline in corneal dendritic cell density at the 28±2 days follow-up, assessed and quantified via in vivo corneal confocal microscopy (IVCM)-a specialized imaging tool for ocular surface evaluation.	Baseline and 28 ± 2 days
Best-corrected visual acuity	Best-corrected visual acuity assessed at baseline, 7±2 days, 14±2 days, and 28±2 days.	Baseline, 7 ± 2 days, 14 ± 2 days, and 28 ± 2 days
Intraocular pressure	Intraocular pressure assessed at baseline, 7±2 days, 14±2 days, and 28±2 days.	Baseline, 7±2 days, 14±2 days, and 28±2 days.

Collaborators and Investigators

• Sponsor: Eye & ENT Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Estimated): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 28, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: EENTFudan-JN002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No