JN002 for the Treatment of Dry Eye Disease
ConditionDry Eye
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEye & ENT Hospital of Fudan University
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Placebo Ophthalmic Solution (Vehicle)
- JN002 Ophthalmic Solution (0.05 mg/mL)
- JN002 Ophthalmic Solution (0.1 mg/mL)
Treatment groups
30 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov