JN002 for the Treatment of Dry Eye Disease
Recruiting now · Early Phase 1 · Has a placebo group
Conditions studied: Dry Eye
In brief
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
Key facts
- Study ID
- NCT07245017
- Run by
- Eye & ENT Hospital of Fudan University
- People needed
- 30
- Starts
- 2025-11-24
- Expected to finish
- 2026-03-01
- Last updated by the study team
- 2025-12-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Aged 18 years or older
- Ocular Surface Disease Index (OSDI) score ≥ 13
- Schirmer I test result ≤ 10 mm/5 min
- Fluorescein tear film break-up time < 10 seconds
- Corneal Fluorescein Staining score (National Eye Institute grading) ≥ 4
- Best corrected visual acuity ≥ 0.6
- Intraocular pressure ≤ 21 mmHg
- Voluntarily agrees to participate in the study
You may not qualify if…
- History of refractive surgery or intraocular surgery within the past 6 months
- 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
- Uncontrolled ocular or systemic diseases
- Other conditions deemed by the investigators likely to interfere with study parameters
- Females with plans for pregnancy at enrollment or during the treatment period
Where it is running
- Eye & ENT Hospital of Fudan University — Shanghai, China (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.