JN002 eye drops for dry eye disease
Official title: Randomized, Double-Blind, Placebo-Controlled, Single Center Clinical Trial to Evaluate the Safety and Preliminary Efficacy of JN002 Ophthalmic Solution in Adult Patients With Dry Eye Disease
Run by Eye & ENT Hospital of Fudan University · NCT07245017 · Data updated 2026-11-12
This trial will test whether JN002 eye drops, given three times daily at two different doses, help adults with dry eye disease feel better and improve eye test results compared with placebo.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Eye & ENT Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | November 24, 2025 |
| Main results expected | March 2026 |
| Study ends | March 2026 |
| Registry record updated | December 1, 2025 |
| Trial ID | NCT07245017 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 or older with symptomatic dry eye (OSDI ≥13) and objective signs such as Schirmer I ≤10 mm/5 min, tear break-up time <10 s, and corneal fluorescein staining score ≥4 are the intended participants.
✕Probably not a fit
People with recent refractive or intraocular surgery, active ocular infection or other clinically relevant ocular abnormalities, uncontrolled systemic disease, or women planning pregnancy are unlikely to be eligible or to benefit in this early-phase trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a first-in-human, single-center, randomized, double-blind, placebo-controlled early phase 1 trial comparing two doses of JN002 ophthalmic solution (0.05 mg/mL and 0.1 mg/mL) against vehicle. Adults with dry eye meeting symptom and objective tear-film criteria receive one drop in each eye three times daily and are followed for 28 days with visits at baseline, ~7, ~14, and ~28 days. Outcomes include symptom scores (OSDI), Schirmer I, tear film break-up time, corneal fluorescein staining, visual acuity and intraocular pressure, plus safety monitoring. The design focuses on initial signs of efficacy and the safety/tolerability profile of topical JN002.
Why it matters
Potential benefit: If successful, JN002 could provide a new topical option that reduces dry eye symptoms and improves tear stability with an acceptable safety profile.
How similar studies have gone: Other topical dry-eye medications (for example cyclosporine and lifitegrast) have shown benefit, but JN002 is being tested in humans for the first time and its effects in people are unproven.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Eye & ENT Hospital of Fudan University
Shanghai, China Recruiting
Study contacts
- Study coordinator: Jiaxu Hong
- Email: Jiaxu.hong@fdeent.org
- Phone: 021-64377134
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.