Dry EyeEarly Phase 1NCT07245017
JN002 for the Treatment of Dry Eye Disease
A Early Phase 1 study testing JN002 Ophthalmic Solution (0.05 mg/mL) and JN002 Ophthalmic Solution (0.1 mg/mL) in people with Dry Eye, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- JN002 Ophthalmic Solution (0.05 mg/mL) and JN002 Ophthalmic Solution (0.1 mg/mL)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 24 Nov 2025to Mar 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Eye & ENT Hospital of Fudan University
Shanghai
Jiaxu Hong, 86 21 64377134, Jiaxu.hong@fdeent.org
About this study
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
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
- Conditions
- Dry Eye
- Being tested
- Placebo Ophthalmic Solution (Vehicle), JN002 Ophthalmic Solution (0.05 mg/mL), JN002 Ophthalmic Solution (0.1 mg/mL)
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Ophthalmic Solution (Vehicle)Drug
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)Drug
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)Drug
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 group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | Placebo ophthalmic solution Receives: Drug: Placebo Ophthalmic Solution (Vehicle) |
| Low-Dose JN002 Group | Experimental | JN002 Ophthalmic Solution at a concentration of 0.05 mg/mL Receives: Drug: JN002 Ophthalmic Solution (0.05 mg/mL) |
| High-Dose JN002 Group | Experimental | JN002 Ophthalmic Solution at a concentration of 0.1 mg/mL Receives: Drug: JN002 Ophthalmic Solution (0.1 mg/mL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Fluorescein Staining score
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.
Measured: Baseline, 7±2 days, 14±2 days and 28 ± 2 days
Ocular Surface Disease Index score
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.
Measured: Baseline, 7±2 days, 14±2 days and 28±2 days
Secondary outcomes (4)
Schirmer I test
Change from baseline in Schirmer I test result (measuring aqueous tear secretion) at the 28±2 days follow-up.
Measured: Baseline and 28 ± 2 days
Tear meniscus height
Change from baseline in tear meniscus height at the 28±2 days follow-up.
Measured: Baseline and 28 ± 2 days
Non-invasive tear film break-up time
Change from baseline in non-invasive tear film break-up time (measured via Keratograph 5M) at the 28±2 days follow-up.
Measured: Baseline and 28 ± 2 days
Tear inflammatory cytokines
Change from baseline in tear inflammatory cytokines (IL-1β, IL-6, IL-17A, TNF-α, INF-γ) levels at the 28±2 days follow-up.
Measured: Baseline and 28 ± 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start24 Nov 2025
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245017
- Sponsor's protocol ID
- EENTFudan-JN002
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07245017
- Acronym / sponsor ID
- EENTFudan-JN002
- Conditions
- Dry Eye
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Drug: Placebo Ophthalmic Solution (Vehicle)Placebo ophthalmic solution |
| Low-Dose JN002 Group | Experimental | Drug: JN002 Ophthalmic Solution (0.05 mg/mL)JN002 Ophthalmic Solution at a concentration of 0.05 mg/mL |
| High-Dose JN002 Group | Experimental | Drug: JN002 Ophthalmic Solution (0.1 mg/mL)JN002 Ophthalmic Solution at a concentration of 0.1 mg/mL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Placebo Group |
| 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 | Drug | Low-Dose JN002 Group |
| 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 | Drug | High-Dose JN002 Group |
Primary outcome
Corneal Fluorescein Staining score
Time frame: 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
Time frame: 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.
4 secondary outcomes
Schirmer I test
Time frame: Baseline and 28 ± 2 days
Tear meniscus height
Time frame: Baseline and 28 ± 2 days
Non-invasive tear film break-up time
Time frame: Baseline and 28 ± 2 days
Tear inflammatory cytokines
Time frame: Baseline and 28 ± 2 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing JN002 Ophthalmic Solution (0.05 mg/mL) and JN002 Ophthalmic Solution (0.1 mg/mL) in people with Dry Eye, run by Eye & ENT Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiaxu Hong (021-64377134, Jiaxu.hong@fdeent.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal Fluorescein Staining score (time frame: Baseline, 7±2 days, 14±2 days and 28 ± 2 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.