Dry Eye Disease (DED)
Conditions
Brief summary
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.
Interventions
DEVICEAbsorbable tacrolimus lacrimal canalicular plug
Insertion of an investigational absorbable tacrolimus lacrimal canalicular plug into the lower punctum for temporary mechanical tear duct occlusion combined with local anti-inflammatory drug delivery in moderate to severe dry eye. The plug degrades naturally over time, providing sustained release of tacrolimus to treat dry eye.
DEVICEDissolvable VisiPlug
Insertion of a Dissolvable VisiPlug into the lower punctum for temporary mechanical tear duct occlusion in moderate to severe dry eye.
Sponsors
Zhejiang Raytone Bioscience Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Schirmer I test (Non-anesthetic) | Baseline, Week 12 | Tear secretion is measured using a standardized filter paper strip placed in the lower conjunctival sac for 5 minutes. Results are reported in mm/5 min. An increase indicates improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Total Corneal Fluorescein Staining (tCFS) Score | Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 | The National Eye Institute（NEI） scale assesses corneal fluorescein staining. The cornea is divided into 5 regions, each scored 0-3. Total score ranges from 0 to 15. Higher scores indicate worse corneal epithelial damage. |
| Change From Baseline in Conjunctival Staining Score | Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 | The Lissamine Green Oxford scale assesses conjunctival staining. The conjunctiva is divided into nasal and temporal quadrants, each scored 0-5. Total score ranges from 0 to 10. Higher scores indicate worse conjunctival staining. |
| Change From Baseline in Fluorescein Staining Tear Film Break-Up Time (FBUT) | Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 | FBUT is measured in seconds from the last blink to the appearance of the first black spot on the cornea after fluorescein instillation. A longer time indicates better tear film stability. |
| Change From Baseline in Ocular Surface Disease Index (OSDI) Score | Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 | The OSDI is a 12-item questionnaire assessing ocular symptoms, visual function, and environmental triggers. Each item is scored 0-4. Total score ranges from 0 to 100. Higher scores indicate worse ocular surface disease. |
| Change From Baseline in Dry Eye Symptom Score on the SANDE Visual Analog Scale (VAS) | Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 | The SANDE questionnaire uses a 100-mm horizontal VAS to assess frequency and severity of dry eye symptoms. The score is calculated as the square root of (frequency × severity) and ranges from 0 to 100. Higher scores indicate worse dry eye symptoms. |
| Change From Baseline in Schirmer I test (Non-anesthetic) | Baseline, Week 1, Week 4, Week 8, Week 16, Week 20, Week 24 | Tear secretion is measured using a standardized filter paper strip placed in the lower conjunctival sac for 5 minutes. Results are reported in mm/5 min. An increase indicates improvement. |
| Change From Baseline in Intraocular Pressure (IOP） | Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 | IOP is measured in mmHg using a non-contact tonometer. A lower value within normal range indicates better safety. |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) | Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 | BCVA is assessed using a 5-meter standard logarithmic visual acuity chart. |
| Anterior Segment Examination Anterior Segment Findings | Baseline, Week 24 | The anterior segment will be examined using slit-lamp biomicroscopy. Findings will be categorized as normal or abnormal.Reported as number of participants. |
| Posterior Segment Examination | Baseline, Week 24 | Posterior segment is examined by ophthalmoscopy. Findings will be categorized as normal or abnormal.Reported as number of participants. |
| Patient Comfort Assessment | Baseline, Week 12, Week 24 | Patient comfort is assessed by asking about discomfort or pain. Responses are comfortable or uncomfortable. |
| Adverse Events | Through Week 24 | Number and incidence of adverse events, including serious adverse events, are recorded. A lower number indicates better safety. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORYing Jie, MD
Beijing Tongren Hospital Affiliated to Capital Medical University
Outcome results
None listed