JN002 for the Treatment of Dry Eye Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-24

Study Completion Date

2026-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy and Safety of SJP-0132 Eye Drops in Chinese Patients With Dry Eye Disease

NCT06717152

Dry Eye

COMPLETED PHASE3

A Study to Evaluate the Safety, Tolerability, and Efficacy of A197 in Subjects With Dry Eye Disease

NCT05238597

Dry Eye Disease

COMPLETED PHASE2

The Effects of a Single Intravenous Administration of Secukinumab (AIN457) or Canakinumab (ACZ885) in Dry Eye Patients

NCT01250171

Dry Eye

COMPLETED PHASE2

Safety, PK and Efficacy Study of SJP-0132 in Subjects With Dry Eye Disease

NCT04139122

Dry Eye Disease Dry Eye Syndrome

COMPLETED PHASE1/PHASE2

Study of SY-201 Ophthalmic Solution in Subjects With Dry Eye Disease

NCT05370495

Dry Eye Disease

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dry Eye

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo Group

Placebo ophthalmic solution

Group Type PLACEBO_COMPARATOR

Placebo Ophthalmic Solution (Vehicle)

Intervention Type DRUG

Placebo ophthalmic solution (vehicle without active ingredient JN002), administered three times daily (1 drop per eye per dose) for 28 ± 2 consecutive days

Low-Dose JN002 Group

JN002 Ophthalmic Solution at a concentration of 0.05 mg/mL

Group Type EXPERIMENTAL

JN002 Ophthalmic Solution (0.05 mg/mL)

Intervention Type 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

High-Dose JN002 Group

JN002 Ophthalmic Solution at a concentration of 0.1 mg/mL

Group Type EXPERIMENTAL

JN002 Ophthalmic Solution (0.1 mg/mL)

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No