Dry EyeEarly Phase 1NCT07908251
a Novel siRNA Eyedrops for DED Treatment
A Early Phase 1 study testing Low dose Arm and High dose Arm in people with Dry Eye, run by Eye & ENT Hospital of Fudan University.
Trial summary
A single-center, randomized, double-blind, placebo-controlled, cross-over clinical trial designed to evaluate the effectiveness and safety of a novel siRNA eye drops for the treatment of dry eye syndrome 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?
- Low dose Arm and High dose Arm
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Jan 2027
- 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
- Age ≥18 years at the time of consent.
- Provision of written informed consent.
- Male and female subjects of childbearing potential agree to use medically approved contraception during the trial and for 90 days after the trial ends.
- Subject-reported history of Dry Eye Disease (DED) in both eyes for at least 6 months prior to Visit 0.
- Subjects who have used artificial tears within 30 days prior to Visit 0 must discontinue their use for at least 72 hours before Visit 0.
- Tear film break-up time (TFBUT) ≤5 seconds at Visit 0.
Show all 11Show fewer
- Ocular Surface Disease Index (OSDI) score ≥25 at Visit 0.
- Unanesthetized Schirmer's Test I ≤10 mm/5 minutes at Visit 0.
- Total corneal fluorescein staining (tCFS) score ≥2 (NEI scale, sum of 5 regions) at Visit 0.
- At least one eye (the same eye) must satisfy all criteria for TFBUT, Schirmer's Test, and tCFS at Visit 0.
- Ability and willingness to follow instructions, including participation in all trial assessments and visits.
Who cannot join
- History of ocular or periocular malignancies.
- DED secondary to scarring (e.g., radiation, chemical burns, Stevens-Johnson syndrome) or conjunctival goblet cell destruction.
- Active or anticipated ocular allergies during the trial.
- Ocular or systemic infections (bacterial, viral, or fungal), including fever, herpes simplex keratitis, or ongoing antibiotic therapy at Visit 0.
- History of glaucoma.
- History of immunodeficiency, HIV, hepatitis B/C, acute hepatitis A, or organ/bone marrow transplantation.
Show all 24Show fewer
- Significant chronic disease interfering with study parameters (e.g., severe cardiopulmonary disease, uncontrolled hypertension, or diabetes), as determined by the investigator.
- Blood donation or significant blood loss (>400 mL) within 56 days prior to Visit 0.
- Active ocular rosacea, periocular acne, or pterygium.
- Eyelid anatomical abnormalities (e.g., lagophthalmos, entropion, or ectropion) or abnormal blinking.
- Clinically significant slit-lamp or fundus findings requiring treatment or potentially interfering with trial results.
- Intraocular or ocular laser surgery or meibomian gland procedures within 180 days prior to Visit 0, or planned during the trial.
- Punctal plug insertion or removal within the specified windows (60 days for surgical procedures and 180 days for dissolvable plugs), or planned insertion/removal or expected dissolution during the trial.
- Use of systemic immunomodulators, oral doxycycline, or tetracyclines within 90 days prior to Visit 0, or anticipated irregular use during the trial.
- Use of topical immunomodulators (e.g., cyclosporine A or tacrolimus) within 30 days prior to Visit 0.
- Use of medications known to induce dry eye (e.g., diuretics, antidepressants, or antihistamines) within 30 days prior to Visit 0, or anticipated irregular use.
- Active blepharitis or meibomian gland dysfunction (MGD) treated with eyelid scrubs, massage, systemic antibiotics, or similar treatments within 30 days prior to Visit 0, or anticipated irregular treatment.
- Use of ocular or systemic steroids or mast cell stabilizers within 30 days prior to Visit 0.
- Contact lens wear within 14 days prior to Visit 0 or planned use during the trial.
- Known hypersensitivity to the investigational drug, excipients, fluorescein, or trial-related substances.
- Pregnant, lactating, or planning pregnancy.
- Household members enrolled in this trial, or direct involvement of study staff or their relatives in trial management.
- Participation in other drug or device trials within 30 days or 5 half-lives (whichever is longer) prior to screening, or planned participation during this trial.
- Any condition that, in the judgment of the investigator or sponsor, may pose significant risk, confound study results, hinder participation, or compromise the subject's best interests.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
A single-center, randomized, double-blind, placebo-controlled, cross-over clinical trial designed to evaluate the effectiveness and safety of a novel siRNA eye drops for the treatment of dry eye syndrome
- Conditions
- Dry Eye
- Being tested
- Low dose Arm, High dose Arm, Placebo Arm
- 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.
Low dose ArmDrug
Low-dose siRNA eyedrops，one drop per eye, twice daily (BID) for 28 days. Adjunctive therapy: 0.3% Hyaluronic Acid (HA) eye drops, three times daily (TID).
High dose ArmDrug
High-dose siRNA eyedrops, one drop per eye, twice daily (BID) for 28 days. Adjunctive therapy: 0.3% Hyaluronic Acid (HA) eye drops, three times daily (TID).
Placebo ArmDrug
Vehicle control, one drop per eye, twice daily (BID) for 28 days. Adjunctive therapy: 0.3% Hyaluronic Acid (HA) eye drops, three times daily (TID).
| Study group | Role | What they receive |
|---|---|---|
| Placebo Arm | Placebo comparator | Not described Receives: Drug: Placebo Arm |
| High Dose Arm | Experimental | Not described Receives: Drug: High dose Arm |
| Low dose Arm | Experimental | Not described Receives: Drug: Low dose Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Period Baseline to Week 4 in Total Corneal Fluorescein Staining
Total corneal fluorescein staining (tCFS) will be assessed at the beginning and end of each 4-week treatment period. The change from the period-specific baseline to the end of each treatment period will be calculated. Results will be summarized according to the treatment received (low-dose, high-dose, or placebo), using data from both treatment periods.
Measured: Week 0 and Week 4 (Period 1); Week 8 and Week 12 (Period 2).
the proportion of CFS responders (defined as ≥3-grade improvement in CFS score)
Measured: Week 0 and Week 4 (Period 1); Week 8 and Week 12 (Period 2).
Number of Participants With Treatment-Emergent Ocular Adverse Events
Ocular safety will be assessed by recording treatment-emergent ocular adverse events during each 4-week treatment period. The number and percentage of participants experiencing at least one ocular adverse event will be summarized separately for the low-dose, high-dose, and placebo treatments, using data from both treatment periods according to the treatment received.
Measured: Week 0 and Week 4 (Period 1); Week 8 and Week 12 (Period 2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study startSep 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (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
- Crossover
- Model description
- This study employed a three-sequence, two-period incomplete block crossover design. Eligible subjects were randomly assigned in a 1:1:1 ratio to one of three treatment sequences (A, B, or C). Each sequence comprised two 4-week treatment periods, separated by a 4-week washout interval. The specific sequences were: Sequence A: Placebo → Low-dose Sequence B: Low-dose → High-dose Sequence C: High-dose → Placebo
- 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
- Principal investigator, Jiaxu Hong, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908251
- Sponsor's protocol ID
- EENTFudan-siRNA
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2026
- Last updated
- 2 Nov 2026
- 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 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Novel siRNA Eyedrops for DED Treatment
- ClinicalTrials.gov ID
- NCT07908251
- Acronym / sponsor ID
- EENTFudan-siRNA
- Conditions
- Dry Eye
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 2 Nov 2026 (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.
A single-center, randomized, double-blind, placebo-controlled, cross-over clinical trial designed to evaluate the effectiveness and safety of a novel siRNA eye drops for the treatment of dry eye syndrome
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This study employed a three-sequence, two-period incomplete block crossover design. Eligible subjects were randomly assigned in a 1:1:1 ratio to one of three treatment sequences (A, B, or C). Each sequence comprised two 4-week treatment periods, separated by a 4-week washout interval. The specific sequences were: Sequence A: Placebo → Low-dose Sequence B: Low-dose → High-dose Sequence C: High-dose → Placebo
| Arm | Type | Receives |
|---|---|---|
| Placebo Arm | Placebo comparator | Drug: Placebo Arm |
| High Dose Arm | Experimental | Drug: High dose Arm |
| Low dose Arm | Experimental | Drug: Low dose Arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥18 years at the time of consent.
- Provision of written informed consent.
- Male and female subjects of childbearing potential agree to use medically approved contraception during the trial and for 90 days after the trial ends.
- Subject-reported history of Dry Eye Disease (DED) in both eyes for at least 6 months prior to Visit 0.
- Subjects who have used artificial tears within 30 days prior to Visit 0 must discontinue their use for at least 72 hours before Visit 0.
Key exclusion criteria (24 listed)
- History of ocular or periocular malignancies.
- DED secondary to scarring (e.g., radiation, chemical burns, Stevens-Johnson syndrome) or conjunctival goblet cell destruction.
- Active or anticipated ocular allergies during the trial.
- Ocular or systemic infections (bacterial, viral, or fungal), including fever, herpes simplex keratitis, or ongoing antibiotic therapy at Visit 0.
- History of glaucoma.
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 |
|---|---|---|
| Low dose ArmLow-dose siRNA eyedrops，one drop per eye, twice daily (BID) for 28 days. Adjunctive therapy: 0.3% Hyaluronic Acid (HA) eye drops, three times daily (TID). | Drug | Low dose Arm |
| High dose ArmHigh-dose siRNA eyedrops, one drop per eye, twice daily (BID) for 28 days. Adjunctive therapy: 0.3% Hyaluronic Acid (HA) eye drops, three times daily (TID). | Drug | High Dose Arm |
| Placebo ArmVehicle control, one drop per eye, twice daily (BID) for 28 days. Adjunctive therapy: 0.3% Hyaluronic Acid (HA) eye drops, three times daily (TID). | Drug | Placebo Arm |
Primary outcome
Change From Period Baseline to Week 4 in Total Corneal Fluorescein Staining
Time frame: Week 0 and Week 4 (Period 1); Week 8 and Week 12 (Period 2).
Total corneal fluorescein staining (tCFS) will be assessed at the beginning and end of each 4-week treatment period. The change from the period-specific baseline to the end of each treatment period will be calculated. Results will be summarized according to the treatment received (low-dose, high-dose, or placebo), using data from both treatment periods.
the proportion of CFS responders (defined as ≥3-grade improvement in CFS score)
Time frame: Week 0 and Week 4 (Period 1); Week 8 and Week 12 (Period 2).
Number of Participants With Treatment-Emergent Ocular Adverse Events
Time frame: Week 0 and Week 4 (Period 1); Week 8 and Week 12 (Period 2).
Ocular safety will be assessed by recording treatment-emergent ocular adverse events during each 4-week treatment period. The number and percentage of participants experiencing at least one ocular adverse event will be summarized separately for the low-dose, high-dose, and placebo treatments, using data from both treatment periods according to the treatment received.
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 2 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Dry Eye
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Low dose Arm and High dose Arm in people with Dry Eye, run by Eye & ENT Hospital of Fudan University.
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 11 inclusion and 24 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Department chief, M.D., Ph.D, (021-64377134, yokchingwu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Period Baseline to Week 4 in Total Corneal Fluorescein Staining (time frame: Week 0 and Week 4 (Period 1); Week 8 and Week 12 (Period 2).). The study lists 3 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 2 Nov 2026.