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Recruiting NCT07245017

JN002 for the Treatment of Dry Eye Disease

Early Phase I Interventional Dry Eye

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Placebo Ophthalmic Solution (Vehicle), JN002 Ophthalmic Solution (0.05 mg/mL), JN002 Ophthalmic Solution (0.1 mg/mL).
Who it may be relevant to
Registry conditions: Dry Eye. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

Interventions

  • 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

Primary outcome measures

  • Corneal Fluorescein Staining score [Time frame: Baseline, 7±2 days, 14±2 days and 28 ± 2 days]
  • Ocular Surface Disease Index score [Time frame: Baseline, 7±2 days, 14±2 days and 28±2 days]
Secondary outcome measures (4)
  • Schirmer I test [Time frame: Baseline and 28 ± 2 days]
  • Tear meniscus height [Time frame: Baseline and 28 ± 2 days]
  • Non-invasive tear film break-up time [Time frame: Baseline and 28 ± 2 days]
  • Tear inflammatory cytokines [Time frame: Baseline and 28 ± 2 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Eye & ENT Hospital of Fudan University — Shanghai

Identifiers

NCT: NCT07245017 · EENTFudan-JN002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗