Dry Eye Disease (DED)DED OSDI FBUTNCT06605495
Using Dry Eye As a Disease Model, Investigators Demonstrated the Optimal Selection of Individualized Clinical Interventions and the Superiority of Dynamic Treatment Discrimination in Chinese Medicine.
A study testing fumigation with Chinese medicine, Oral herbal medicine and Modern Western Medicine in people with Dry Eye Disease (DED), run by Xuejing Lu.
Trial summary
In this study, dry eye disease (leukoaraiosis) is used as a model disease, and the methodological system for evaluating the clinical efficacy of Chinese medicine for dry eye disease is constructed with the core of "subgrouping dynamic and static parallel group design", so as to carry out a real-world demonstration… 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?
- fumigation with Chinese medicine, Oral herbal medicine and Modern Western Medicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- No sites listed yet
- Study dates
- 25 Sep 2024to 1 Oct 2025
- 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
- Be 18-75 years of age and of any gender
- Meets Western diagnostic criteria for dry eye
- Formed consent and signed the Informed Consent Form
Who cannot join
- Those who are unable to perform a dry eye examination due to various factors
- Patients with severe diseases of the liver or renal system, or infectious eye diseases
- Those who are allergic to the medications used in this study
- Women who are pregnant or breastfeeding Mental illness or intellectual disability; Participants in clinical trials of other drugs within the last 3 months.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Demonstration Clinical Study of Dry Eye Disease Advantage
In this study, dry eye disease (leukoaraiosis) is used as a model disease, and the methodological system for evaluating the clinical efficacy of Chinese medicine for dry eye disease is constructed with the core of "subgrouping dynamic and static parallel group design", so as to carry out a real-world demonstration study of dry eye disease as a dominant disease in Chinese medicine treatment. The purpose of this study is to demonstrate the selection of individualized clinical interventions and the superiority of dynamic diagnosis and treatment using dry eye as a disease model. The study provides a clinical example of a subgroup-based dynamic and static parallel group design for TCM clinical research on "disease-based integrated treatment". Based on the conclusions of the efficacy evaluation study, investigators will provide real-world clinical data of dry eye syndrome for the artificial intelligence prediction of the integrated platform of individualized clinical evaluation and evidence support of Chinese medicine with multi-source data integration.
- Conditions
- Dry Eye Disease (DED)
- Being tested
- fumigation with Chinese medicine, Oral herbal medicine, Modern Western Medicine
- 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.
fumigation with Chinese medicineCombination product
Eye fumigation with the Eyesight Eye Therapy,10 minutes once daily for 6 weeks.
Oral herbal medicineDrug
Patients were identified into the appropriate group according to the individual evidence profile, and the herbal formula under the corresponding evidence profile was taken orally as one dose of 150 ml of water twice a day for 6 weeks.
Modern Western MedicineDrug
Referring to the Chinese Expert Consensus on Dry Eye: Treatment (2020), this course of treatment totaled 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Chinese Medicine External Treatment Group | Active comparator | Not described Receives: Combination Product: fumigation with Chinese medicine |
| Chinese Medicine Internal Treatment Group (Oral Herbal Medicine) | Experimental | Not described Receives: Drug: Oral herbal medicine |
| Western medicine treatment group | Active comparator | Not described Receives: Drug: Modern Western Medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chinese Medical Evidence Scale
The TCM evidence scale converts symptoms and signs into TCM evidence, and assigns 1, 2, and 3 points according to three levels of severity, with reference to the "Guiding Principles for Clinical Research on New Drugs of Traditional Chinese Medicine" and the "International TCM Clinical Practice Guidelines for Stemmed Eyes (2021-12-14)". If the points of TCM evidence are higher or unchanged after the intervention, it means that the intervention measures are ineffective or inefficient, and that patients\' clinical symptoms do not improve significantly or their conditions worsen after the treatment. If the TCM syndrome score increases or remains unchanged after the intervention compared with that before treatment, it means that the intervention is ineffective or inefficient, and the patient\'s clinical symptoms do not improve or worsen after treatment.
Measured: From enrollment to end of 6-week treatment
Ocular Surface Disease Index
By evaluating the points before and after the intervention treatment, if the points are lower than before the treatment, it suggests that the intervention treatment is effective, on the contrary, it indicates that the intervention is ineffective or ineffective, and the clinical symptoms of the patients do not improve significantly or worsen after the treatment.
Measured: From enrollment to end of 6-week treatment
Fluorescein Breakup Time
Efficacy was evaluated by the values tested before and after the intervention
Measured: From enrollment to end of 6-week treatment
Secondary outcomes (4)
Schirmer Ⅰ test
Efficacy was evaluated by the values tested before and after the intervention
Measured: From enrollment to end of 6-week treatment
Height of the River of Tears
Efficacy was evaluated by the values tested before and after the intervention
Measured: From enrollment to end of 6-week treatment
fluorescent staining of the cornea
See the Chinese Expert Consensus on Dry Eye: Expert Consensus on Definition and Classification (2020): the cornea was divided into 4 quadrants on average, and each quadrant was scored from 0 to 3 according to the staining of sodium fluorescein, with a score of 0: no staining; 1: 1-30 punctate staining; 2: \>30 punctate staining but staining not fused; and 3: fusion of the corneal punctate staining with the appearance of filaments and ulcers, etc. The final tally scores for each quadrant were summed. The efficacy was evaluated by tallying the scores detected before and after the intervention.
Measured: From enrollment to end of 6-week treatment
Classification of blepharoplasty deficiency
The efficacy was evaluated by scoring the blepharoplasty area values detected before and after the intervention. According to the Chinese Expert Consensus on Meibomian Gland Dysfunction (2023), investigators graded the results as follows: score 0: no meibomian gland deficiency; score 1: meibomian gland deficiency ratio \<1/3; score 2: meibomian gland deficiency ratio 1/3-2/3; and score 3: meibomian gland deficiency ratio \>2/3.
Measured: From enrollment to end of 6-week treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start25 Sep 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
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
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuejing Lu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xuejing Lu, Ineye Hospital of Chengdu University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06605495
- Sponsor's protocol ID
- 2024YH008
- Acronym
- DED OSDI FBUT
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstration Clinical Study of Dry Eye Disease Advantage
- ClinicalTrials.gov ID
- NCT06605495
- Acronym / sponsor ID
- DED OSDI FBUT / 2024YH008
- Conditions
- Dry Eye Disease (DED)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Xuejing LuUniversity, hospital or other
- Study start
- 25 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 20 Sep 2024 (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.
In this study, dry eye disease (leukoaraiosis) is used as a model disease, and the methodological system for evaluating the clinical efficacy of Chinese medicine for dry eye disease is constructed with the core of "subgrouping dynamic and static parallel group design", so as to carry out a real-world demonstration study of dry eye disease as a dominant disease in Chinese medicine treatment. The purpose of this study is to demonstrate the selection of individualized clinical interventions and the superiority of dynamic diagnosis and treatment using dry eye as a disease model. The study provides a clinical example of a subgroup-based dynamic and static parallel group design for TCM clinical research on "disease-based integrated treatment". Based on the conclusions of the efficacy evaluation study, investigators will provide real-world clinical data of dry eye syndrome for the artificial intelligence prediction of the integrated platform of individualized clinical evaluation and evidence support of Chinese medicine with multi-source data integration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chinese Medicine External Treatment Group | Active comparator | Combination Product: fumigation with Chinese medicine |
| Chinese Medicine Internal Treatment Group (Oral Herbal Medicine) | Experimental | Drug: Oral herbal medicine |
| Western medicine treatment group | Active comparator | Drug: Modern Western Medicine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be 18-75 years of age and of any gender
- Meets Western diagnostic criteria for dry eye
- Formed consent and signed the Informed Consent Form
Key exclusion criteria (4 listed)
- Those who are unable to perform a dry eye examination due to various factors
- Patients with severe diseases of the liver or renal system, or infectious eye diseases
- Those who are allergic to the medications used in this study
- Women who are pregnant or breastfeeding Mental illness or intellectual disability; Participants in clinical trials of other drugs within the last 3 months.
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 |
|---|---|---|
| fumigation with Chinese medicineEye fumigation with the Eyesight Eye Therapy,10 minutes once daily for 6 weeks. | Combination product | Chinese Medicine External Treatment Group |
| Oral herbal medicinePatients were identified into the appropriate group according to the individual evidence profile, and the herbal formula under the corresponding evidence profile was taken orally as one dose of 150 ml of water twice a day for 6 weeks. | Drug | Chinese Medicine Internal Treatment Group (Oral Herbal Medicine) |
| Modern Western MedicineReferring to the Chinese Expert Consensus on Dry Eye: Treatment (2020), this course of treatment totaled 6 weeks. | Drug | Western medicine treatment group |
Primary outcome
Chinese Medical Evidence Scale
Time frame: From enrollment to end of 6-week treatment
The TCM evidence scale converts symptoms and signs into TCM evidence, and assigns 1, 2, and 3 points according to three levels of severity, with reference to the "Guiding Principles for Clinical Research on New Drugs of Traditional Chinese Medicine" and the "International TCM Clinical Practice Guidelines for Stemmed Eyes (2021-12-14)". If the points of TCM evidence are higher or unchanged after the intervention, it means that the intervention measures are ineffective or inefficient, and that patients\' clinical symptoms do not improve significantly or their conditions worsen after the treatment. If the TCM syndrome score increases or remains unchanged after the intervention compared with that before treatment, it means that the intervention is ineffective or inefficient, and the patient\'s clinical symptoms do not improve or worsen after treatment.
Ocular Surface Disease Index
Time frame: From enrollment to end of 6-week treatment
By evaluating the points before and after the intervention treatment, if the points are lower than before the treatment, it suggests that the intervention treatment is effective, on the contrary, it indicates that the intervention is ineffective or ineffective, and the clinical symptoms of the patients do not improve significantly or worsen after the treatment.
Fluorescein Breakup Time
Time frame: From enrollment to end of 6-week treatment
Efficacy was evaluated by the values tested before and after the intervention
4 secondary outcomes
Schirmer Ⅰ test
Time frame: From enrollment to end of 6-week treatment
Height of the River of Tears
Time frame: From enrollment to end of 6-week treatment
fluorescent staining of the cornea
Time frame: From enrollment to end of 6-week treatment
Classification of blepharoplasty deficiency
Time frame: From enrollment to end of 6-week treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Dry Eye Disease (DED)
Not yet recruitingPhase 2
Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments
Dry Eye Disease (DED), Graft-Versus-Host Disease(GVHD)
Active, not recruiting
Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
Meibomian Gland Dysfunction, Dry Eye Disease
Not yet recruitingEarly Phase 1
a Novel siRNA Eyedrops for DED Treatment
Dry Eye
Recruiting
Treating Contact Lens Discomfort With Cyclosporine 0.1% Ophthalmic Solution
Dry Eye Disease (DED), Contact Lens Discomfort (CLD)
Not yet recruitingPhase 1
A Clinical Study to Evaluate the Safety and Effectiveness of MSCohi-O Lens in the Treatment of Immune-related Ocular Surface Diseases.
Keratitis, Autoimmunity
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.
Questions about this trial
What is this clinical trial studying?
A study testing fumigation with Chinese medicine, Oral herbal medicine and Modern Western Medicine in people with Dry Eye Disease (DED), run by Xuejing Lu.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lu (18908178510, luxuejing@cdutcm.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chinese Medical Evidence Scale (time frame: From enrollment to end of 6-week treatment). The study lists 3 primary outcomes in all. 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 2024.