JN002 for the Treatment of Dry Eye Disease
ConditionDry Eye
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEye & ENT Hospital of Fudan University
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Placebo Ophthalmic Solution (Vehicle)
DrugPlacebo 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)
DrugJN002 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)
DrugJN002 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
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: Placebo GroupPlacebo comparator 1 intervention
Group B: Low-Dose JN002 GroupExperimental treatment 1 intervention
Group C: High-Dose JN002 GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, 7±2 days, 14±2 days and 28 ± 2 days2
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.
Time frame
Baseline, 7±2 days, 14±2 days and 28±2 daysSecondary outcomes
1
Schirmer I test
Change from baseline in Schirmer I test result (measuring aqueous tear secretion) at the 28±2 days follow-up.
Time frame
Baseline and 28 ± 2 days2
Tear meniscus height
Change from baseline in tear meniscus height at the 28±2 days follow-up.
Time frame
Baseline and 28 ± 2 days3
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.
Time frame
Baseline and 28 ± 2 days4
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.
Time frame
Baseline and 28 ± 2 daysOther outcomes
1
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.
Time frame
Baseline and 28 ± 2 days2
Best-corrected visual acuity
Best-corrected visual acuity assessed at baseline, 7±2 days, 14±2 days, and 28±2 days.
Time frame
Baseline, 7 ± 2 days, 14 ± 2 days, and 28 ± 2 days3
Intraocular pressure
Intraocular pressure assessed at baseline, 7±2 days, 14±2 days, and 28±2 days.
Time frame
Baseline, 7±2 days, 14±2 days, and 28±2 days.Sponsors and contacts
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Source ClinicalTrials.gov