JN002 for the Treatment of Dry Eye Disease

NCT07245017 | Recruiting Early Phase 1

• 1 other identifier: EENTFudan-JN002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Dry Eye

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

• Tear inflammatory cytokines

  Baseline and 28 ± 2 days

Other Outcomes (3)

• Corneal dendritic cell density

  Baseline and 28 ± 2 days

• Best-corrected visual acuity

  Baseline, 7 ± 2 days, 14 ± 2 days, and 28 ± 2 days

• Intraocular pressure

  Baseline, 7±2 days, 14±2 days, and 28±2 days.

Study Arms (3)

Placebo Group

PLACEBO COMPARATOR

Placebo ophthalmic solution

Drug: Placebo Ophthalmic Solution (Vehicle)

Low-Dose JN002 Group

EXPERIMENTAL

JN002 Ophthalmic Solution at a concentration of 0.05 mg/mL

Drug: JN002 Ophthalmic Solution (0.05 mg/mL)

High-Dose JN002 Group

EXPERIMENTAL

JN002 Ophthalmic Solution at a concentration of 0.1 mg/mL

Drug: JN002 Ophthalmic Solution (0.1 mg/mL)

Interventions

Placebo Ophthalmic Solution (Vehicle) DRUG

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

Placebo Group

JN002 Ophthalmic Solution (0.05 mg/mL) DRUG

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

Low-Dose JN002 Group

JN002 Ophthalmic Solution (0.1 mg/mL) DRUG

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

High-Dose JN002 Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

Eye & ENT Hospital of Fudan University

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Central Study Contacts

Jiaxu Hong

CONTACT

021-64377134; Jiaxu.hong@fdeent.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 24, 2025
• Study Start: November 24, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)