Safety and Efficacy Study of Absorbable Tacrolimus Lacrimal Canalicular Plug for Dry Eye

A Clinical New Technology Study on Evaluating the Safety and Efficacy of Absorbable Tacrolimus Lacrimal Canalicular Plug for Dry Eye Treatment

The goal of this clinical trial is to test if a new dissolvable tacrolimus plug placed in the tear duct is safe and to see how well it works for adults with moderate to severe dry eye. The main questions it aims to answer are:

Is the dissolvable tacrolimus plug safe for the eyes?

How well does the plug work to improve dry eye?

Participants will be divided into three groups:

Two groups will receive the dissolvable tacrolimus plug inserted into their tear duct (in two slightly different sizes).

One comparison group will receive an already approved dissolvable plug (Dissolvable VisiPlug).

All participants will use a standard lubricating eye drop four times a day in both eyes.

All participants will attend follow-up visits for 24 weeks so doctors can check their eye health and any side effects.

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.