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NCT Number: NCT07245017

JN002 for the Treatment of 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

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

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

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

Primary outcomes

  1. Corneal Fluorescein Staining score

    Time frame: Baseline, 7±2 days, 14±2 days and 28 ± 2 days

    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.

  2. Ocular Surface Disease Index score

    Time frame: Baseline, 7±2 days, 14±2 days and 28±2 days

    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.

Secondary outcomes

  1. Schirmer I test

    Time frame: Baseline and 28 ± 2 days

    Change from baseline in Schirmer I test result (measuring aqueous tear secretion) at the 28±2 days follow-up.

  2. Tear meniscus height

    Time frame: Baseline and 28 ± 2 days

    Change from baseline in tear meniscus height at the 28±2 days follow-up.

  3. Non-invasive tear film break-up time

    Time frame: Baseline and 28 ± 2 days

    Change from baseline in non-invasive tear film break-up time (measured via Keratograph 5M) at the 28±2 days follow-up.

  4. Tear inflammatory cytokines

    Time frame: Baseline and 28 ± 2 days

    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.

Other outcomes

  1. Corneal dendritic cell density

    Time frame: Baseline and 28 ± 2 days

    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.

  2. Best-corrected visual acuity

    Time frame: Baseline, 7 ± 2 days, 14 ± 2 days, and 28 ± 2 days

    Best-corrected visual acuity assessed at baseline, 7±2 days, 14±2 days, and 28±2 days.

  3. Intraocular pressure

    Time frame: Baseline, 7±2 days, 14±2 days, and 28±2 days.

    Intraocular pressure assessed at baseline, 7±2 days, 14±2 days, and 28±2 days.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiaxu Hong

CONTACT

[email protected]

021-64377134

Sponsors and collaborators

Lead sponsor

Eye & ENT Hospital of Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 24, 2025
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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