JN002 for the Treatment of Dry Eye Disease

Eye & ENT Hospital of Fudan University

Status and phase: Enrolling; Early Phase 1

Conditions: Dry Eye

Treatments: Drug: JN002 Ophthalmic Solution (0.05 mg/mL); Drug: Placebo Ophthalmic Solution (Vehicle); Drug: JN002 Ophthalmic Solution (0.1 mg/mL)

Study type: Interventional

Funder types: Other

Identifiers

NCT07245017

EENTFudan-JN002

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

30 participants in 3 patient groups, including a placebo group

Placebo Group

Placebo Comparator group

Description:

Placebo ophthalmic solution

Treatment:

Drug: Placebo Ophthalmic Solution (Vehicle)

Low-Dose JN002 Group

Experimental group

Description:

JN002 Ophthalmic Solution at a concentration of 0.05 mg/mL

Treatment:

Drug: JN002 Ophthalmic Solution (0.05 mg/mL)

High-Dose JN002 Group

Experimental group

Description:

JN002 Ophthalmic Solution at a concentration of 0.1 mg/mL

Treatment:

Drug: JN002 Ophthalmic Solution (0.1 mg/mL)