Dry Eye
Conditions
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
Interventions
Placebo ophthalmic solution (vehicle without active ingredient JN002), administered three times daily (1 drop per eye per dose) for 28 ± 2 consecutive days
DRUGJN002 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
DRUGJN002 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
Sponsors
Eye & ENT Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged 18 years or older 2. Ocular Surface Disease Index (OSDI) score ≥ 13 3. Schirmer I test result ≤ 10 mm/5 min 4. Fluorescein tear film break-up time \< 10 seconds 5. Corneal Fluorescein Staining score (National Eye Institute grading) ≥ 4 6. Best corrected visual acuity ≥ 0.6 7. Intraocular pressure ≤ 21 mmHg 8. Voluntarily agrees to participate in the study
Exclusion criteria
1. History of refractive surgery or intraocular surgery within the past 6 months 2. 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 3. Uncontrolled ocular or systemic diseases 4. Other conditions deemed by the investigators likely to interfere with study parameters 5. Females with plans for pregnancy at enrollment or during the treatment period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal Fluorescein Staining score | 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. |
| Ocular Surface Disease Index score | 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
| Measure | Time frame | Description |
|---|---|---|
| Schirmer I test | Baseline and 28 ± 2 days | Change from baseline in Schirmer I test result (measuring aqueous tear secretion) at the 28±2 days follow-up. |
| Tear inflammatory cytokines | 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. |
| Tear meniscus height | Baseline and 28 ± 2 days | Change from baseline in tear meniscus height at the 28±2 days follow-up. |
| Non-invasive tear film break-up time | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Best-corrected visual acuity | 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. |
| Corneal dendritic cell density | 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. |
| Intraocular pressure | 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. |
Countries
China
Contacts
Primary ContactJiaxu Hong
Outcome results
None listed