Dry Eye DiseasePhase 2NCT05486728
Phase II Study of SHJ002 Sterile Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye Disease
A Phase 2 study of Dry Eye Disease, run by Dreamhawk Vision Biotech, Inc. at 4 sites in 3 countries.
Trial summary
The purpose of this study is to measure efficacy and safety with SHJ002 sterile ophthalmic solution compared to vehicle in participants with Dry Eye Disease (DED). SHJ002 is an antisense oligonucleotide to neutralize a specific microRNA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 8 Feb 2023to 7 Dec 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female participants 18 years of age or older inclusive, at the time of signing the informed consent.
- Have DED in both eyes for ≥ 6 months
- Female participants must be 1 year postmenopausal, surgically sterilized, or females of childbearing potential with a negative urine pregnancy test
Who cannot join
- Ocular surface corneal disease, other than DED.
- Lid margin disorder other than meibomian gland dysfunction (MGD)
- Presence of any ocular condition
- Any history of eyelid surgery or intraocular/ocular surgery
- Cauterization of the punctum or punctal plug
- Use of lid scrubs containing chemicals or baby shampoo, or eye makeup
Show all 12Show fewer
- Use of any of the contraindicated drugs medications
- Any changes in the dosing of any chronically used systemic drug
- Disease, condition, or disorder that in the judgement of Investigator could confound study assessments or limit compliance to study protocol
- Known history of alcohol and/or drug abuse within 12 months
- Known allergy or contraindication to any component of investigational product (IP) formulation or diagnostic agents.
- Participation in any drug or device clinical investigation within 30 days
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Thailand2 sites
King Chulalongkorn Memorial Hospital
Bangkok, 10330
Ramathibodi Hospital, Mahidol University
Bangkok, 10400
Taiwan1 site
Kaohsiung Veterans General Hospital
Kaohsiung City, Kaohsiung, 813414
About this study
Official title: A Double-Blinded, Parallel, Vehicle-Controlled Phase 2 Study of SHJ002 Sterile Ophthalmic Solution in Participants With Dry Eye Disease
The purpose of this study is to measure efficacy and safety with SHJ002 sterile ophthalmic solution compared to vehicle in participants with Dry Eye Disease (DED). SHJ002 is an antisense oligonucleotide to neutralize a specific microRNA.
Read the detailed description
Participants will be randomized to treatment with SHJ002 Ophthalmic Solution or vehicle which will be administered to each eye BID for 84 days.
- Conditions
- Dry Eye Disease
- Being tested
- SHJ002/Vehicle
- Keywords
- Dry Eye Disease
- 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.
SHJ002/VehicleDrug
Topical ophthalmic
| Study group | Role | What they receive |
|---|---|---|
| SHJ002 | Experimental | SHJ002 Ophthalmic Solution: topically administered to each eye BID for 84 days Receives: Drug: SHJ002/Vehicle |
| Vehicle | Placebo comparator | Vehicle: topically administered to each eye BID for 84 days Receives: Drug: SHJ002/Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Total Corneal Fluorescein Staining (NEI Scale)
NEI Corneal Fluorescein Staining Score (range: 0 to 15, where higher scores indicate worse corneal staining). The score is the sum across five corneal regions (each 0-3).
Measured: Baseline and Day 84
Secondary outcomes (2)
Change From Baseline in SANDE Score
The SANDE questionnaire assesses dry eye symptoms on a scale from 0 (no symptoms) to 100 (worst symptoms). The reported values represent change from baseline to Day 84 (Day 84 - Baseline).
Measured: Baseline and Day 84
Change From Baseline in Eye Dryness Score (Visual Analogue Scale)
100-mm horizontal line from 0 (no discomfort) to 100 (worst discomfort). Reported values represent change from baseline to Day 84.
Measured: Baseline and Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start8 Feb 2023
- Primary completion7 Dec 2023
- Study completion7 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-Blinded, Parallel, Vehicle-Controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dreamhawk Vision Biotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486728
- Sponsor's protocol ID
- SHJ002-DED2203
- Status last verified
- Sep 2025
- First submitted
- 2 Aug 2022
- Last updated
- 14 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kasetsuwan N, Jaross N, Reinprayoon U, Daruwalla Z, Choo J, Liang YH, Juo SH, Liang CL. Assessing the Efficacy, Safety Profile, and Tolerability of Anti-microRNA-328 Anti-sense (SHJ002) for Dry Eye Disease: A Randomized Phase 2 Trial. Clin Ther. 2026 Jun;48(6):525-529. doi: 10.1016/j.clinthera.2026.03.023. Epub 2026 Apr 25.
PubMed 42036272
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blinded, Parallel, Vehicle-Controlled Phase 2 Study of SHJ002 Sterile Ophthalmic Solution in Participants With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT05486728
- Acronym / sponsor ID
- SHJ002-DED2203
- Conditions
- Dry Eye Disease
- Keywords
- Dry Eye Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Dreamhawk Vision Biotech, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- 7 Dec 2023 (actual)
- Study completion
- 7 Dec 2023 (actual)
- First posted
- 4 Aug 2022 (actual)
- Results
- Posted 14 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to measure efficacy and safety with SHJ002 sterile ophthalmic solution compared to vehicle in participants with Dry Eye Disease (DED). SHJ002 is an antisense oligonucleotide to neutralize a specific microRNA.
Detailed description
Participants will be randomized to treatment with SHJ002 Ophthalmic Solution or vehicle which will be administered to each eye BID for 84 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double-Blinded, Parallel, Vehicle-Controlled
| Arm | Type | Receives |
|---|---|---|
| SHJ002 | Experimental | Drug: SHJ002/VehicleSHJ002 Ophthalmic Solution: topically administered to each eye BID for 84 days |
| Vehicle | Placebo comparator | Drug: SHJ002/VehicleVehicle: topically administered to each eye BID for 84 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female participants 18 years of age or older inclusive, at the time of signing the informed consent.
- Have DED in both eyes for ≥ 6 months
- Female participants must be 1 year postmenopausal, surgically sterilized, or females of childbearing potential with a negative urine pregnancy test
Key exclusion criteria (12 listed)
- Ocular surface corneal disease, other than DED.
- Lid margin disorder other than meibomian gland dysfunction (MGD)
- Presence of any ocular condition
- Any history of eyelid surgery or intraocular/ocular surgery
- Cauterization of the punctum or punctal plug
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 |
|---|---|---|
| SHJ002/VehicleTopical ophthalmic | Drug | SHJ002, Vehicle |
Primary outcome
Change From Baseline in Total Corneal Fluorescein Staining (NEI Scale)
Time frame: Baseline and Day 84
NEI Corneal Fluorescein Staining Score (range: 0 to 15, where higher scores indicate worse corneal staining). The score is the sum across five corneal regions (each 0-3).
2 secondary outcomes
Change From Baseline in SANDE Score
Time frame: Baseline and Day 84
Change From Baseline in Eye Dryness Score (Visual Analogue Scale)
Time frame: Baseline and Day 84
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42036272Kasetsuwan N, Jaross N, Reinprayoon U, Daruwalla Z, Choo J, Liang YH, Juo SH, Liang CL. Assessing the Efficacy, Safety Profile, and Tolerability of Anti-microRNA-328 Anti-sense (SHJ002) for Dry Eye Disease: A Randomized Phase 2 Trial. Clin Ther. 2026 Jun;48(6):525-529. doi: 10.1016/j.clinthera.2026.03.023. Epub 2026 Apr 25.
- Individual participant dataSharing planned: No
Related trials for Dry Eye Disease
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Dry Eye Disease, run by Dreamhawk Vision Biotech, Inc. at 4 sites in 3 countries.
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 3 inclusion and 12 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: finished, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Thailand, Australia, Taiwan. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Total Corneal Fluorescein Staining (NEI Scale) (time frame: Baseline and Day 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05486728, which also lists 1 linked publication.
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 14 Oct 2025.