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New eye drop offers hope for dry eye sufferers

NCT ID NCT04633213

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an eye drop called HBM9036 in 577 Chinese adults with moderate to severe dry eye. The goal was to see if it reduces eye surface damage and improves symptoms better than a placebo. Participants used the drops for about two months, and doctors measured changes in corneal staining and comfort.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

577 people

The number who actually took part.

Started

Feb 2021

Finished

Aug 2022

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. At least 6 months history of any dry eye symptoms; 2. Must use or feel the need to use any types of eye drops to treat dry eye disease symptoms within 6 months prior to Screening Visit; 3. Best corrected visual acuity (BCVA) ≥ logMAR+0.7 as assessed according to the Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at Screening Visit; 4. At least 1 eye dryness score ≥ 40mm measured by 100mm Visual Analogue Scale (VAS) at Screening Visit; 5. Schirmer's test score (anesthetized) ≥ 1mm and ≤ 10mm in the study eye at Screening Visit; 6. Average tear film breakup time (TFBUT) ≤5 seconds in the study eye at Screening Visit; 7. Total corneal fluorescein staining score ≥ 5.5 according to the Ora Calibra Corneal and Conjunctival Staining Scale at least in the study eye at Screening and Baseline Visits; 8. Conjunctival redness score ≥1 according to the Ora Calibra Conjunctival Redness Scale at least in the study eye at Screening Visit. Exclusion Criteria: 1. At Screening Visit, Subjects observed by investigator with any clinically significant signs including active blepharitis and ocular allergies. Patients with meibomian gland dysfunction that need treatment; 2. Currently active ocular infection (bacterial, viral, or fungal) or any ocular surface inflammation; 3. Patients whose dry eye disease secondary to Sjogren's syndrome, Steven-Johnson Syndrome or chronic graft versus host disease, or patients suffered from serious autoimmune disorders such as systemic lupus erythematosus or rheumatoid arthritis, If their systemic disease are instable or drug application changed such as the type or dose of immunosuppressive biologics had been adjusted within 3 months or had drug withdrawal within 1 month or expected to have their drugs adjusted or discontinued during the study; 4. Planning to undergo any ocular or eyelid surgery; 5. Patients suffered from insertion of temporary lacrimal plug surgery within 6 months or insertion of permanent lacrimal plug surgery within 3 months. Or planning to undergo insertion of lacrimal plug surgery during the study; 6. Use of Cyclosporine A, Tacrolimus or Xiidra within 60 days prior to Screening Visit; 7. History of HBM9036 (HL036) use; 8. Currently use of prescription (including but not limited to antiglaucoma drops) or OTC drugs that locally applied to eyes, artificial tears, ophthalmic gel and eye rinse that cannot be interrupted during the study (excluding medications allowed in this study); pharmacological wash-out periods are required for some drugs.

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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

  • Xiamen Eye Center of Xiamen University

    Xiamen, Fujian, 361100, China

More trials for these conditions

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