JN002 for the Treatment of Dry Eye Disease

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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

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

Study summary

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

Primary outcome measure(s)

• Corneal Fluorescein Staining score — Baseline, 7±2 days, 14±2 days and 28 ± 2 days
  Change from baseline in Corneal Fluorescein Staining (CFS) score at the 7±2 days, 14±2 days and 28±2 days follow-up. CFS is evaluated following the guidelines from the National Eye Institute: the corneal surface is divided into five regions (central, superior, inferior, nasal, temporal), with each region assigned a score ranging from 0 to 3, resulting in a total possible score of 0 to 15-higher scores indicate more severe corneal epithelial damage and a worse clinical outcome.
• Ocular Surface Disease Index score — Baseline, 7±2 days, 14±2 days and 28±2 days
  Change from baseline in Ocular Surface Disease Index (OSDI) score at the 7±2 days, 14±2 days and 28±2 days follow-up. OSDI is assessed via a 12-item self-reported questionnaire, where raw scores are converted to a standardized 0-100 scale through a specific calculation, with higher scores indicating more severe ocular surface disease symptoms.

Trial sites (1)

More Eye & ENT Hospital of Fudan University trials in China

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