New eye drops aim to soothe dry eyes
NCT ID NCT05486728
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 2 trial tested an experimental eye drop called SHJ002 in 85 adults with dry eye disease. The drops are designed to block a specific microRNA linked to inflammation. Researchers measured changes in corneal staining and symptom scores over 84 days to see if the drops are safe and effective compared to a placebo.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SHJ002 (antisense oligonucleotide eye drops)
- What this could lead to
- If successful, this could lead to a new eye drop treatment that reduces dry eye symptoms and corneal damage.
- What could go wrong
- This is an early Phase 2 trial with only 85 people. The drug may not work better than placebo, and long-term safety is unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
85 people
The number who actually took part.
- Started
-
Feb 2023
- Finished
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Dec 2023
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female participants 18 years of age or older inclusive, at the time of signing the informed consent. 2. Have DED in both eyes for ≥ 6 months 3. Female participants must be 1 year postmenopausal, surgically sterilized, or females of childbearing potential with a negative urine pregnancy test Exclusion Criteria: 1. Ocular surface corneal disease, other than DED. 2. Lid margin disorder other than meibomian gland dysfunction (MGD) 3. Presence of any ocular condition 4. Any history of eyelid surgery or intraocular/ocular surgery 5. Cauterization of the punctum or punctal plug 6. Use of lid scrubs containing chemicals or baby shampoo, or eye makeup 7. Use of any of the contraindicated drugs medications 8. Any changes in the dosing of any chronically used systemic drug 9. Disease, condition, or disorder that in the judgement of Investigator could confound study assessments or limit compliance to study protocol 10. Known history of alcohol and/or drug abuse within 12 months 11. Known allergy or contraindication to any component of investigational product (IP) formulation or diagnostic agents. 12. Participation in any drug or device clinical investigation within 30 days
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Australian Eye Specialists
Werribee, Victoria, 3030, Australia
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Kaohsiung Veterans General Hospital
Kaohsiung City, Kaohsiung, 813414, Taiwan
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King Chulalongkorn Memorial Hospital
Bangkok, 10330, Thailand
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Ramathibodi Hospital, Mahidol University
Bangkok, 10400, Thailand
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two eye gels go head to head for dry eye relief
- Can a new eyedrop heal the cornea in dry eye disease?
- Can a daily eye drop safely treat dry eye? phase 3 trial puts tivanisiran to the test
- Can tiny fat bubbles in eye drops soothe dry eyes?
- Can a new eye drop fully clear dry eye redness?
- Could a common dry eye drop shield the Cornea's inner layer?