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New eye drops aim to soothe dry eyes

NCT ID NCT05486728

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

Anyone

Healthy volunteers

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

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

  • Australian Eye Specialists

    Werribee, Victoria, 3030, Australia

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, Kaohsiung, 813414, Taiwan

  • King Chulalongkorn Memorial Hospital

    Bangkok, 10330, Thailand

  • Ramathibodi Hospital, Mahidol University

    Bangkok, 10400, Thailand

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