New eye drop offers hope for dry eye sufferers
NCT ID NCT04633213
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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577 people
The number who actually took part.
- Started
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Feb 2021
- Finished
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Aug 2022
- Lead sponsor
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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
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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. 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
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Xiamen Eye Center of Xiamen University
Xiamen, Fujian, 361100, China
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Other studies related to the condition(s) this trial covers.
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