Can a dissolvable eye plug deliver targeted relief for dry eye?
NCT ID NCT07806240
First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time
Summary
This trial tests a new dissolvable plug placed in the tear duct that releases tacrolimus, an anti-inflammatory drug, to treat moderate to severe dry eye. Adults aged 18 to 75 with dry eye will receive either the tacrolimus plug in one of two sizes or an approved dissolvable plug for comparison. All participants will also use standard lubricating eye drops. Researchers will track eye health and side effects over 24 weeks to see if the plug is safe and improves tear production and symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Absorbable tacrolimus lacrimal canalicular plug
- What this could lead to
- If it works, this could offer a new treatment option for moderate to severe dry eye, delivering anti-inflammatory medication directly to the eye over time.
- What could go wrong
- This is an early-stage trial with only 40 participants, so results may not apply to everyone. The plug could cause irritation, infection, or not improve symptoms as hoped.
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
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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40 people
The number who actually took part.
- Started
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Apr 2025
- Finished
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Feb 2026
- 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 to 75 years
- 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: * Aged 18 to 75 years old. * At the screening period and baseline visit, the participant must have dry eye as evidenced by both the following signs and symptoms, and the same eye (study eye) must meet all the following criteria: * tCFS score \>= 6 points * OSDI score \>= 23 points * Dry eye symptom score \>= 40 points according to the VAS * Schirmer I Test: \>= 1 mm and \<= 10 mm * FBUT \<= 10 s * History of dry eye for \>= 6 months. * Currently using or having used lubricating gel or artificial tears for dry eye, but still experience dry eye symptoms. * Best Corrected Visual Acuity (BCVA) \>= 0.2 in both eyes. * The participant or their legal guardian voluntarily signs the ICF, clearly understands the benefits and risks of the study, and has good compliance. * The participant must have the ability and willingness to comply with the study procedures. Exclusion Criteria: * Abnormal punctal structure of both eyes, making it impossible to place lacrimal canalicular plugs in the lower punctum of the study eye; or participants for whom the investigator assesses that the desired effect may not be achieved due to ocular structure after placement. * A history of malignant tumors in the eye/periorbital region or other parts of the body; unstable systemic diseases within 1 month prior to screening; or conditions judged by the investigator to be incompatible with the study or unable to meet the requirements of study visit follow-up. * Participants with other autoimmune diseases. * Participants with secondary ocular scars that the investigator assesses may affect participant compliance or outcome evaluation. * Participants with a history of possible or confirmed ocular infection or ocular herpes in either eye. * Participants with concurrent severe diseases of the heart, liver, kidneys, cerebrovascular system, and hematopoietic system. * Structural abnormalities, blink abnormalities, or ocular diseases in either eye that may affect trial evaluation within 1 month prior to screening. * Participants requiring treatment with any topical or systemic antibiotics, topical steroids, or other prescription drugs, or with diseases that may require such drug treatment during the trial. * Use of the following ocular medications within the specified period prior to screening: * Topical or systemic antihistamines: within 14 days prior to screening for any ocular medication * Topical immunosuppressants: within 6 weeks prior to screening * Topical, inhaled, intranasal, or topical cutaneous corticosteroids, mast cell stabilizers: within 14 days prior to screening * Other drugs for dry eye treatment: within 14 days prior to screening * Receipt of other dry eye treatments within 30 days prior to screening. * Dry eye caused or exacerbated by ocular surgery that has not yet stabilized. * Diagnosis of chronic epiphora due to lacrimal canalicular obstruction or lacrimal duct inflammatory diseases within 6 months prior to screening. * Use of contact lenses or scleral lenses within 2 weeks prior to screening, or planned use during the study period. * Use of systemic or topical drugs known to cause dry eye or affect efficacy evaluation within 7 days prior to screening. * Use of any serum tears, oral doxycycline, oral tetracycline, or any ocular drugs/cosmetics that promote eyelash growth within 30 days prior to screening, and inability to discontinue use during the study. * Planned use of any topical ophthalmic drugs or prescriptions other than the specified study drugs during the study period. * Previous corneal transplantation or planned corneal transplantation during the study period. * A history of any ocular surface surgery or external eye surgery within 6 months prior to screening, or planned ocular or eyelid surgery during the study period. * A history of intraocular surgery, ocular laser surgery, Nd:YAG laser capsulotomy, or any other surgery affecting the meibomian glands within 6 months prior to screening. * Intraocular pressure (IOP) exceeding 21 mmHg in either eye; or a history of glaucoma or ocular hypertension; or receipt of antiglaucoma drug treatment in either eye; or receipt of antiglaucoma laser or surgical treatment in the study eye within 90 days prior to screening. * Receipt or removal of lacrimal canalicular plugs within 3 months prior to screening, or a history of surgery for severe dry eye. * Current participation in any other ongoing drug or device study, or participation in a study within 1 month after the screening visit. * Known allergy or sensitivity to any components of the clinical or trial drugs/devices used in the study. * Pregnant women, lactating women, and women planning pregnancy. * Other conditions deemed unsuitable for participation in the trial by the investigator.
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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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Beijing Tongren Hospital Affiliated to Capital Medical University
Beijing, China
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Other studies related to the condition(s) this trial covers.
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