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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Group | Placebo Comparator | Placebo ophthalmic solution |
|
| Low-Dose JN002 Group | Experimental | JN002 Ophthalmic Solution at a concentration of 0.05 mg/mL |
|
| High-Dose JN002 Group | Experimental | JN002 Ophthalmic Solution at a concentration of 0.1 mg/mL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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. |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiaxu Hong | Contact | 021-64377134 | Jiaxu.hong@fdeent.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye & ENT Hospital of Fudan University | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| 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 |
|
| 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 |
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. |