Safety and Efficacy Study of RTP-008 (an Absorbable Tacrolimus Lacrimal Canalicular Plug) for Dry Eye

NCT07806240 | Completed

• 1 other identifier: TG202411-RTP-008
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

RTP-008, an absorbable tacrolimus lacrimal canalicular plug, targets two key pathophysiological mechanisms of dry eye: tear retention and local anti-inflammation. This clinical trial aims to evaluate the safety and efficacy of RTP-008 in adults with moderate to severe dry eye. The main questions it aims to answer are:

• Is RTP-008 safe for the eyes?
• How well does the plug work to improve dry eye?
• Which size provides a better fit for the human lacrimal canaliculus after swelling? Participants will be divided into three groups:
• Two groups will receive RTP-008 inserted into their lacrimal canaliculus (in two slightly different sizes).
• One comparison group will receive an already approved dissolvable plug. 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.

Conditions

Dry Eye Disease (DED)

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Schirmer I test (Non-anesthetic)

  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.

  Baseline, Week 12

Secondary Outcomes (12)

• 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

• Change From Baseline in Conjunctival Staining Score

  Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

• 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

• 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

• 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

Study Arms (3)

RTP-008 (Larger Size)

EXPERIMENTAL

Insertion of Absorbable Tacrolimus Lacrimal Canalicular Plug

Device: RTP-008

RTP-008 (Smaller Size)

EXPERIMENTAL

Insertion of Absorbable Tacrolimus Lacrimal Canalicular Plug

Device: RTP-008

Dissolvable Plug

ACTIVE COMPARATOR

Approved Device

Device: Dissolvable Plug

Interventions

RTP-008 DEVICE

Insertion of RTP-008 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.

RTP-008 (Larger Size); RTP-008 (Smaller Size)

Dissolvable Plug DEVICE

Insertion of a Dissolvable Plug into the lower punctum for temporary mechanical tear duct occlusion in moderate to severe dry eye.

Dissolvable Plug

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Raytone Bioscience Co.,Ltd: lead

Study Sites (1)

Beijing Tongren Hospital Affiliated to Capital Medical University

Beijing, China

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Ying Jie, MD

  Beijing Tongren Hospital Affiliated to Capital Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: September 8, 2026
• Study Start: April 8, 2025
• Primary Completion: December 9, 2025
• Study Completion: February 28, 2026
• Last Updated: September 24, 2026

Record last verified: 2026-09

Locations

CN (1)