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New treatment option for Dry Eye
Official title JN002 for the Treatment of Dry Eye Disease
ClinicalTrials.gov ID: NCT07245017
What this study is testing
What is JN002 Ophthalmic Solution (0.05 mg/mL)?
JN002 Ophthalmic Solution (0.05 mg/mL) is an investigational medicine, given as an once-daily, being studied as a potential treatment for dry eye.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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...
- 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
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.