Dry Eye Disease (DED)NCT07806240
Safety and Efficacy Study of RTP-008 (an Absorbable Tacrolimus Lacrimal Canalicular Plug) for Dry Eye
A study testing RTP-008 and Dissolvable Plug in people with Dry Eye Disease (DED), run by Zhejiang Raytone Bioscience Co.,Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dry Eye Disease (DED)
- What is being tested?
- RTP-008 and Dissolvable Plug
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 8 Apr 2025to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Show all 29Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tongren Hospital Affiliated to Capital Medical University
Beijing
About this study
Official title: A Clinical New Technology Study on Evaluating the Safety and Efficacy of RTP-008 ( an Absorbable Tacrolimus Lacrimal Canalicular Plug) for Dry Eye Treatment
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?
Read more
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)
- Being tested
- RTP-008, Dissolvable Plug
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RTP-008Device
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.
Dissolvable PlugDevice
Insertion of a Dissolvable Plug into the lower punctum for temporary mechanical tear duct occlusion in moderate to severe dry eye.
| Study group | Role | What they receive |
|---|---|---|
| RTP-008 (Larger Size) | Experimental | Insertion of Absorbable Tacrolimus Lacrimal Canalicular Plug Receives: Device: RTP-008 |
| RTP-008 (Smaller Size) | Experimental | Insertion of Absorbable Tacrolimus Lacrimal Canalicular Plug Receives: Device: RTP-008 |
| Dissolvable Plug | Active comparator | Approved Device Receives: Device: Dissolvable Plug |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 12
Secondary outcomes (12)
Change From Baseline in Total Corneal Fluorescein Staining (tCFS) Score
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.
Measured: Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Change From Baseline in Conjunctival Staining Score
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.
Measured: 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)
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.
Measured: 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
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.
Measured: 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)
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.
Measured: Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
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.
Measured: Baseline, Week 1, Week 4, Week 8, Week 16, Week 20, Week 24
Change From Baseline in Intraocular Pressure (IOP）
IOP is measured in mmHg using a non-contact tonometer. A lower value within normal range indicates better safety.
Measured: Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Change From Baseline in Best Corrected Visual Acuity (BCVA)
BCVA is assessed using a 5-meter standard logarithmic visual acuity chart.
Measured: Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Anterior Segment Examination Anterior Segment Findings
The anterior segment will be examined using slit-lamp biomicroscopy. Findings will be categorized as normal or abnormal.Reported as number of participants.
Measured: Baseline, Week 24
Posterior Segment Examination
Posterior segment is examined by ophthalmoscopy. Findings will be categorized as normal or abnormal.Reported as number of participants.
Measured: Baseline, Week 24
Patient Comfort Assessment
Patient comfort is assessed by asking about discomfort or pain. Responses are comfortable or uncomfortable.
Measured: Baseline, Week 12, Week 24
Adverse Events
Number and incidence of adverse events, including serious adverse events, are recorded. A lower number indicates better safety.
Measured: Through Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start8 Apr 2025
- Primary completion9 Dec 2025
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Disease (DED)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Raytone Bioscience Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ying Jie, MD, Principal investigator, Beijing Tongren Hospital Affiliated to Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806240
- Sponsor's protocol ID
- TG202411-RTP-008
- Status last verified
- Sep 2026
- First submitted
- 12 Aug 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical New Technology Study on Evaluating the Safety and Efficacy of RTP-008 ( an Absorbable Tacrolimus Lacrimal Canalicular Plug) for Dry Eye Treatment
- ClinicalTrials.gov ID
- NCT07806240
- Acronym / sponsor ID
- TG202411-RTP-008
- Conditions
- Dry Eye Disease (DED)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Zhejiang Raytone Bioscience Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 9 Dec 2025 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RTP-008 (Larger Size) | Experimental | Device: RTP-008Insertion of Absorbable Tacrolimus Lacrimal Canalicular Plug |
| RTP-008 (Smaller Size) | Experimental | Device: RTP-008Insertion of Absorbable Tacrolimus Lacrimal Canalicular Plug |
| Dissolvable Plug | Active comparator | Device: Dissolvable PlugApproved Device |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- 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.
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RTP-008Insertion 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. | Device | RTP-008 (Larger Size), RTP-008 (Smaller Size) |
| Dissolvable PlugInsertion of a Dissolvable Plug into the lower punctum for temporary mechanical tear duct occlusion in moderate to severe dry eye. | Device | Dissolvable Plug |
Primary outcome
Change From Baseline in Schirmer I test (Non-anesthetic)
Time frame: 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.
12 secondary outcomes
Change From Baseline in Total Corneal Fluorescein Staining (tCFS) Score
Time frame: Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Change From Baseline in Conjunctival Staining Score
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Change From Baseline in Schirmer I test (Non-anesthetic)
Time frame: Baseline, Week 1, Week 4, Week 8, Week 16, Week 20, Week 24
Change From Baseline in Intraocular Pressure (IOP）
Time frame: Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Change From Baseline in Best Corrected Visual Acuity (BCVA)
Time frame: Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Anterior Segment Examination Anterior Segment Findings
Time frame: Baseline, Week 24
Posterior Segment Examination
Time frame: Baseline, Week 24
Patient Comfort Assessment
Time frame: Baseline, Week 12, Week 24
Adverse Events
Time frame: Through Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying Jie, MD principal investigator
Beijing Tongren Hospital Affiliated to Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RTP-008 and Dissolvable Plug in people with Dry Eye Disease (DED), run by Zhejiang Raytone Bioscience Co.,Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Schirmer I test (Non-anesthetic) (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.