Dry Eye SyndromesNCT06089317
Traditional Chinese Medicine Ultrasonic Atomization Treatment for Dry Eye Disease
A study testing TCM ultrasonic atomization treatment with herbal Compound Decoction (CD), TCM ultrasonic atomization treatment with Dendrobii Caulis (DC) and TCM ultrasonic atomization treatment with Houttuynia Cordata (HC) in people with Dry Eye Syndromes, run by Chinese University of Hong Kong at 4 sites in Hong Kong.
Trial summary
Dry eye disease (DED) is the most prevalent ocular surface disease worldwide. Standard treatments like artificial tears show limited effect. Regarding the ultrasonic atomization, the ultrasonic nebulizer produces consistent steam from the solution with a treatment effect delivered to the ocular surface. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- TCM ultrasonic atomization treatment with herbal Compound Decoction (CD), TCM ultrasonic atomization treatment with Dendrobii Caulis (DC) and TCM ultrasonic atomization treatment with Houttuynia Cordata (HC)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 4 sitesHong Kong
- Study dates
- 28 Jul 2024to 22 Jun 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least one eye of subjects meets DED diagnostic criteria as the Tear Film and Ocular Surface Society (TFOS) Dry Eye Workshop (DEWS II); and
- Ocular Surface Disease Index (OSDI)≥13 and <33; and
- The age range between years 18-80, no sex limitation; and
- Symptoms of dry eye for at least 6 months; and
- Can complete the questionnaires independently and understand Chinese or English.
Who cannot join
- Had or currently suffering from other concomitant ocular surface diseases, including chronic conjunctivitis, ocular rosacea, cicatricial pemphigoid, graft-versus-host disease, limbal stem cell deficiency, and severe ocular allergy;
- Received any refractive surgery and corneal surgery before, including corneal transplant; or any eye surgery in the past 6 months;
- Receiving DED-related medications, including topical steroid eyedrops, topical antibiotics, topical cyclosporin A, and topical diquafosol;
- Received intense pulsed laser (IPL) or vectored thermal pulsation (VTP) therapy in the past 12 months;
- Received topical antiglaucomatous treatment in the past 12 months
- Plans to use contact lenses during treatment and follow-up periods or used contact lenses 2 weeks before the baseline measurement and recruitment;
Show all 12Show fewer
- Had or currently suffering from severe cardiopulmonary disease, liver and kidney dysfunction, and severe blood system diseases;
- Suffering from glucose-6-phosphate dehydrogenase deficiency (G6PD);
- Had or currently suffering from specific respiratory diseases, e.g. emphysema, bronchitis, asthma, chronic obstructive pulmonary disease, bronchial dilatation;
- Has adverse reaction history to herbs used in this study before;
- Whose TCM constitution is manifested as "yang-deficiency" or diagnosed by TCM practitioners that their TCM syndrome is not suitable for the atomization treatment;
- Pregnancy, preparation for pregnancy, or lactation;
Trial locations and contacts
4 sites in 1 country.
Hong Kong4 sites
Hong Kong Eye Hospital
Kowloon, Hong Kong
The Chinese University of Hong Kong Eye Centre (CUHKEC)
Kowloon, 000000
The CUHK Medical Centre (CUHKMC)
Shatin, 000 000
Prince of Wales Hospital
Shatin, 000000
About this study
Official title: Traditional Chinese Medicine Ultrasonic Atomization Treatment for Dry Eye Disease: A Randomized, Double-masked, Placebo-controlled Trial
Dry eye disease (DED) is the most prevalent ocular surface disease worldwide. Standard treatments like artificial tears show limited effect. Regarding the ultrasonic atomization, the ultrasonic nebulizer produces consistent steam from the solution with a treatment effect delivered to the ocular surface. We aim to evaluate the effectiveness and safety of traditional Chinese medicine (TCM) ultrasonic atomization as an adjuvant treatment for DED.
This is a randomized double-masked, active- and placebo-controlled trial. 200 subjects will be equally assigned to the herbal compound decoction(CD) group, dendrobium caulis (DC) group, houttuynia cordata (HC) group, placebo atomization(PA) group, and artificial tear (AT) group by stratified permuted block randomization.
Subjects of CD, DC, HC, and PA groups will receive TCM ultrasonic atomization treatment (6 times/week). All patients will receive hypromellose 0.3% w/v lubricant eye drops for a 1-week wash-out and a 4-month follow-up period. Outcomes included non-invasive tear break-up times, corneal and conjunctival fluorescein staining, and other dry eye-related parameter examined by LipiView II Ocular Surface Interferometer, OCULUS® Keratograph 5M, and slit lamp biomicroscope evaluated by masked clinical assessors at baseline, week 1, 2, 3, 4 and month 2, 3, 4. The other subjective questionnaires like the Ocular Surface Disease Index (OSDI) questionnaire are also selected.
- Conditions
- Dry Eye Syndromes
- Being tested
- TCM ultrasonic atomization treatment with herbal Compound Decoction (CD), TCM ultrasonic atomization treatment with Dendrobii Caulis (DC), TCM ultrasonic atomization treatment with Houttuynia Cordata (HC), Placebo TCM ultrasonic atomization treatment (PA), Artificial Tears (AT)
- Keywords
- Dry Eye Syndromes, Traditional Chinese Medicine, Ultrasonic Atomization, Randomized Controlled Trial
- 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.
TCM ultrasonic atomization treatment with herbal Compound Decoction (CD)Drug
The subjects will receive TCM ultrasonic atomization treatment with the ultrasonic nebulizer (WH-2000, YueHua, China) 6 days a week, once daily, 10 minutes per session, for 4 weeks. The solution for atomization of the CD group is TCM compound decoction.
The prescription of atomization solution in the CD group contains Honeysuckle flower (金銀花) 5g, Chrysanthemum flower (菊花) 5g, Pale betterflybush flower (密蒙花) 5g, Mild mint herb (薄荷) 5g, Barbary wolfberry fruit (枸杞子) 10g, and Ophiopogon japonicus (麥冬) 5g.
Subjects will be treated with hypromellose 0.3% w/v eye drops four times per day too.
TCM ultrasonic atomization treatment with Dendrobii Caulis (DC)Drug
The subjects will receive TCM ultrasonic atomization treatment with the ultrasonic nebulizer (WH-2000, YueHua, China) 6 days a week, once daily, 10 minutes per session, for 4 weeks. The solution for atomization of the DC group is Dendrobii Caulis extracts.
The prescription of the DC group contains Dendrobium (石斛) 35g.
Subjects will be treated with hypromellose 0.3% w/v eye drops four times per day too.
TCM ultrasonic atomization treatment with Houttuynia Cordata (HC)Drug
The subjects will receive TCM ultrasonic atomization treatment with the ultrasonic nebulizer (WH-2000, YueHua, China) 6 days a week, once daily, 10 minutes per session, for 4 weeks. The solution for atomization of the HC group is Heartleaf Houttuynia Herb extracts.
The prescription of the HC group contains Heartleaf Houttuynia Herb(魚腥草) 35g.
Subjects will be treated with hypromellose 0.3% w/v eye drops four times per day too.
Placebo TCM ultrasonic atomization treatment (PA)Drug
The subjects will receive TCM ultrasonic atomization treatment with the ultrasonic nebulizer (WH-2000, YueHua, China) 6 days a week, once daily, 10 minutes per session, for 4 weeks. The solution for atomization of the PA group is low-concentration compound decoction (5%) same with the CD group.
Subjects will be treated with hypromellose 0.3% w/v eye drops four times per day too.
Artificial Tears (AT)Drug
The subjects will receive lubricant eye drop (Hypromellose 0.3% w/v Eye Drops) four times per day only.
| Study group | Role | What they receive |
|---|---|---|
| Compound Decoction (CD) group | Active comparator | Not described Receives: Drug: TCM ultrasonic atomization treatment with herbal Compound Decoction (CD); Drug: Artificial Tears (AT) |
| Dendrobii Caulis (DC) group | Active comparator | Not described Receives: Drug: TCM ultrasonic atomization treatment with Dendrobii Caulis (DC); Drug: Artificial Tears (AT) |
| Houttuynia Cordata (HC) group | Active comparator | Not described Receives: Drug: TCM ultrasonic atomization treatment with Houttuynia Cordata (HC); Drug: Artificial Tears (AT) |
| Placebo Atomization (PA) group | Placebo comparator | Not described Receives: Drug: Placebo TCM ultrasonic atomization treatment (PA); Drug: Artificial Tears (AT) |
| Artificial Tears (AT) group | Other | Not described Receives: Drug: Artificial Tears (AT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Ocular Surface Disease Index (OSDI)
The Ocular Surface Disease Index (OSDI) is a 12-item symptom frequency-based questionnaire. It is self-administered to assess DED-related symptoms and severity.
The final OSDI score is calculated by dividing the product of the total sum of the score and 25 by the total number of answered questions, with a range from 0 to 100. The score reflects the severity of DED(normal: 0-12, mild: 13-22, moderate: 23-32, severe: >33).
Measured: baseline to 4th week
Change in Non-invasive Tear Break-up Times (NIBUT)
The non-invasive tear break-up time (NIBUT) will be measured by the OCULUS Keratograph® 5M (Oculus, Wetzlar, Germany). Subjects will be instructed to keep their eyes on as much as possible during the examination. First and average NIBUT will be recorded by the machine accordingly.
Shortening NIBUT(< 10 seconds) suggests instability of the tear film.
Measured: baseline to 4th week
Secondary outcomes (19)
Change in Ocular Surface Disease Index (OSDI)
The Ocular Surface Disease Index (OSDI) is a 12-item symptom frequency-based questionnaire. It is self-administered to assess DED-related symptoms and severity.
The final OSDI score is calculated by dividing the product of the total sum of the score and 25 by the total number of answered questions, with a range from 0 to 100. The score reflects the severity of DED: normal: 0-12, mild: 13-22, moderate: 23-32, severe: >33).
Measured: 4 months
Change in symptom Assessment iN Dry Eye (SANDE, modified)
Symptom Assessment iN Dry Eye (SANDE) questionnaire is a 2-item frequency- and severity-based visual analog scale. It is self-administered to evaluate the frequency and severity of dry eye symptoms.
The final SANDE score is calculated by obtaining the square root of the product of the frequency of symptoms score and the severity of symptoms score, with a range from 0 (minimal degree of dry eye symptoms) to 100 (maximal degree of dry eye symptoms)
Measured: 4 months
Change in 36-Item Short Form Health Survey (SF-36)
The 36-Item Short Form Health Survey (SF-36) is a 36-item self-administered questionnaire, with 8 domains included: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). The physical health sub-scale and Mental health sub-scale will be graded respectively.
Measured: 4 months
Change in the Work Productivity and Activity Impairment Questionnaire: General Health V2.0 (WPAI:GH)
The Work Productivity and Activity Impairment Questionnaire: General Health V2.0 (WPAI: GH) is a 6-item questionnaire that measures impairments in work and activities.
Measured: 4 months
Change in Non-Invasive Tear Break Up Times (NIBUT)
Non-Invasive tear break up time (NIBUT) will be measured by the OCULUS Keratograph® 5M (Oculus, Wetzlar, Germany) in both eyes. Participants were instructed to keep their eyes on as much as possible during the examination. First and average NIKBUTs will be recorded by the machine.
Shortening NIBUT(< 10 seconds) suggests instability of the tear film.
Measured: 4 months
Changes in Tear Meniscus Height (TMH)
The tear meniscus height (TMH) will be measured by the OCULUS Keratograph® 5M (Oculus, Wetzlar, Germany).
Measured: 4 months
Changes in Bulbar Redness
Bulbar conjunctival hyperaemia is automatically evaluated the Keratograph 5M (OCULUS, Wetzlar, Germany) according to the JENVIS grading scale from 0 to 4.
Measured: 4 months
Changes in Lipid Layer Thickness
The lipid layer thickness (LLT) of the tear film will be determined with the LipiView ® II Ocular Surface Interferometer (TearScience, Morrisville, NC). Minimum, Maximum, and Average thickness in nanometers (nm) will be measured.
Measured: 4 months
Changes in Partial Blinking Rate
The partial blinking rate will be reported as the percentage of incomplete blinks. The total and partial blinking times will be automatically recorded by the LipiView ® II Ocular Surface Interferometer (TearScience, Morrisville, NC).
Measured: 4 months
Changes in Meiboscore
The meiboscore grading will be based on the infrared meibography captured by the LipiView ® II Ocular Surface Interferometer (TearScience, Morrisville, NC). Both superior and inferior eyelids will be recorded. The result will be graded by a masked assessor.
The grading scheme is a 3-point scale (grade 0, no meibomian gland atrophy; grade 1, less than 1/3 area of glands lost; grade 2, 1/3-2/3 area of glands lost; grade 3, more than 2/3 area of glands lost)
Measured: 4 months
Change in Tear Film Breakup Time (TBUT)
The tear film breakup time (TBUT) is the time of the initial breakup of the tear film after a full blink. 2% Sodium fluorescein will be instilled in both eyes of the subjects. A masked follow-up assessor will do the examination via the slit lamp with a blue cobalt light. The TBUT will be measured three times with a stopwatch and taken on average.
Measured: 4 months
Change in Corneal and Conjunctival Fluorescein Staining
Fluorescein sodium liquid will be instilled on the ocular surface. After 3 minutes, the corneal and conjunctival punctate epithelial erosions will be observed and graded via the slit lamp biomicroscope with a blue cobalt light.
The Oxford Grading System is selected for grading. The severity will be divided into 6 grades (Grade 0, absent; Grade 1, minimal; Grade 2, mild; Grade 3, moderate; Grade 4, marked; Grade 5, severe)
Measured: 4 months
Change in Expressibility of Meibomian Glands in the Meibomian Glands Yielding Liquid Secretion (MGYLS) (the inferior eyelid)
Expressibility of the inferior eyelid meibomian glands is assessed with the Meibomian Gland Evaluator (TearScience, North Carolina, USA) applied inferior to central aspects of the inferior eyelid margin. The result is graded by a masked assessor.
The meibomian glands yielding liquid secretion (MGYLS) is the total number of glands that yield lipid secretions at the central aspects of the eyelid margin.
Measured: 4 months
Change in Quality of Expressed Meibum
The meibomian gland evaluator will be applied to the central aspects of the inferior eyelid margin. The result will be graded by a masked assessor.
Each gland in each area will be assessed for expressibility and graded according to a 4-point scale: grade 0, no secretion; grade 1, inspissated/ toothpaste-like expression; grade 2, cloudy fluid secretion; and grade 3, clear fluid/normal secretion. The sum scores of 5 glands will be between 0 and 15.
Measured: 4 months
Change in Lid Margin and Eyelash Abnormalities
Lid margin and eyelash abnormalities will be accessed by a slit lamp, including telangiectasia, meibomian gland capping, Demodex lash cylindrical collarettes, staphylococcal lash crusting, and seborrheic lash crusting.
All items will be graded based on a four-point scale: grade 0, absent; grade 1, mild; grade 2, moderate; grade 3, severe.
Measured: 4 months
Change in Tear Film Osmolarity (TFO)
The tear film osmolarity (TFO) is measured by the ScoutPro™ Osmolarity System (TearLab , San Diego, CA) via the disposable test card in both eyes.
The normal osmolarity was considered as lower than 308 mOsm/L in both eyes. A difference more than 8 mOsm/L between two eyes reflects the stability of the tear film.
Measured: 4 months
Changes in Schirmer I test
The Schirmer I test (ST) will be performed by sterile standard filter paper strips without anesthesia. The filter paper strips will be gently put on the temporal side of both lower eyelids for 5 minutes. The wetting length by tears in each strip will be recorded in nanometers (mm) by a masked assessor.
The strips will be collected in sterile centrifuge tubes respectively for further laboratory tests.
Measured: 4 months
Changes in Matrix metallopeptidase 9 (MMP-9)
The MMP-9 enzyme-linked immunosorbent assay (ELISA) development kit (Invitrogen, Carlsbad, CA)) will be applied for measurement of the concentration of MMP-9 in participants' tears.
Measured: 4 months
Adverse events (AEs)
The adverse events (AEs) will be the number of incidents based on a checklist of symptoms, signs, and diseases by patients' reporting, slit-lamp examination, or doctor's diagnosis.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start28 Jul 2024
- Primary completion22 Jun 2025
- Study completion22 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Model description
- A total of 200 subjects with mild to moderate DED will be recruited. Only one eye of recruited subjects with the shorter NIBUT will be selected and analyzed as the study eye. The subjects will be randomly divided into TCM compound decoction (CD) group, dendrobium caulis (DC) group, houttuynia cordata (HC) group, placebo atomization (PA) group, and artificial tears (AT) group equally. An online-based clinical trial randomization tool with a permuted block and stratification randomization method is applied for the randomization, and block sizes are randomly chosen. Stratification variances is sex and age.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelvin Kam Lung Chong, MD, Chinese University of Hong Kong
- Investigators
- Kelvin KL Chong, MBChB, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089317
- Sponsor's protocol ID
- CMDF-21B2005A_R1
- Status last verified
- Mar 2026
- First submitted
- 13 Oct 2023
- Last updated
- 19 Mar 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 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional Chinese Medicine Ultrasonic Atomization Treatment for Dry Eye Disease: A Randomized, Double-masked, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06089317
- Acronym / sponsor ID
- CMDF-21B2005A_R1
- Conditions
- Dry Eye Syndromes
- Keywords
- Dry Eye Syndromes, Traditional Chinese Medicine, Ultrasonic Atomization, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 28 Jul 2024 (actual)
- Primary completion
- 22 Jun 2025 (actual)
- Study completion
- 22 Jun 2025 (actual)
- First posted
- 18 Oct 2023 (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.
Dry eye disease (DED) is the most prevalent ocular surface disease worldwide. Standard treatments like artificial tears show limited effect. Regarding the ultrasonic atomization, the ultrasonic nebulizer produces consistent steam from the solution with a treatment effect delivered to the ocular surface. We aim to evaluate the effectiveness and safety of traditional Chinese medicine (TCM) ultrasonic atomization as an adjuvant treatment for DED.
This is a randomized double-masked, active- and placebo-controlled trial. 200 subjects will be equally assigned to the herbal compound decoction(CD) group, dendrobium caulis (DC) group, houttuynia cordata (HC) group, placebo atomization(PA) group, and artificial tear (AT) group by stratified permuted block randomization.
Subjects of CD, DC, HC, and PA groups will receive TCM ultrasonic atomization treatment (6 times/week). All patients will receive hypromellose 0.3% w/v lubricant eye drops for a 1-week wash-out and a 4-month follow-up period. Outcomes included non-invasive tear break-up times, corneal and conjunctival fluorescein staining, and other dry eye-related parameter examined by LipiView II Ocular Surface Interferometer, OCULUS® Keratograph 5M, and slit lamp biomicroscope evaluated by masked clinical assessors at baseline, week 1, 2, 3, 4 and month 2, 3, 4. The other subjective questionnaires like the Ocular Surface Disease Index (OSDI) questionnaire are also selected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- A total of 200 subjects with mild to moderate DED will be recruited. Only one eye of recruited subjects with the shorter NIBUT will be selected and analyzed as the study eye. The subjects will be randomly divided into TCM compound decoction (CD) group, dendrobium caulis (DC) group, houttuynia cordata (HC) group, placebo atomization (PA) group, and artificial tears (AT) group equally. An online-based clinical trial randomization tool with a permuted block and stratification randomization method is applied for the randomization, and block sizes are randomly chosen. Stratification variances is sex and age.
| Arm | Type | Receives |
|---|---|---|
| Compound Decoction (CD) group | Active comparator | Drug: TCM ultrasonic atomization treatment with herbal Compound Decoction (CD), Drug: Artificial Tears (AT) |
| Dendrobii Caulis (DC) group | Active comparator | Drug: TCM ultrasonic atomization treatment with Dendrobii Caulis (DC), Drug: Artificial Tears (AT) |
| Houttuynia Cordata (HC) group | Active comparator | Drug: TCM ultrasonic atomization treatment with Houttuynia Cordata (HC), Drug: Artificial Tears (AT) |
| Placebo Atomization (PA) group | Placebo comparator | Drug: Placebo TCM ultrasonic atomization treatment (PA), Drug: Artificial Tears (AT) |
| Artificial Tears (AT) group | Other | Drug: Artificial Tears (AT) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least one eye of subjects meets DED diagnostic criteria as the Tear Film and Ocular Surface Society (TFOS) Dry Eye Workshop (DEWS II); and
- Ocular Surface Disease Index (OSDI)≥13 and <33; and
- The age range between years 18-80, no sex limitation; and
- Symptoms of dry eye for at least 6 months; and
- Can complete the questionnaires independently and understand Chinese or English.
Key exclusion criteria (12 listed)
- Had or currently suffering from other concomitant ocular surface diseases, including chronic conjunctivitis, ocular rosacea, cicatricial pemphigoid, graft-versus-host disease, limbal stem cell deficiency, and severe ocular allergy;
- Received any refractive surgery and corneal surgery before, including corneal transplant; or any eye surgery in the past 6 months;
- Receiving DED-related medications, including topical steroid eyedrops, topical antibiotics, topical cyclosporin A, and topical diquafosol;
- Received intense pulsed laser (IPL) or vectored thermal pulsation (VTP) therapy in the past 12 months;
- Received topical antiglaucomatous treatment in the past 12 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 |
|---|---|---|
| TCM ultrasonic atomization treatment with herbal Compound Decoction (CD)The subjects will receive TCM ultrasonic atomization treatment with the ultrasonic nebulizer (WH-2000, YueHua, China) 6 days a week, once daily, 10 minutes per session, for 4 weeks. The solution for atomization of the CD group is TCM compound decoction. The prescription of atomization solution in the CD group contains Honeysuckle flower (金銀花) 5g, Chrysanthemum flower (菊花) 5g, Pale betterflybush flower (密蒙花) 5g, Mild mint herb (薄荷) 5g, Barbary wolfberry fruit (枸杞子) 10g, and Ophiopogon japonicus (麥冬) 5g. Subjects will be treated with hypromellose 0.3% w/v eye drops four times per day too. | Drug | Compound Decoction (CD) group |
| TCM ultrasonic atomization treatment with Dendrobii Caulis (DC)The subjects will receive TCM ultrasonic atomization treatment with the ultrasonic nebulizer (WH-2000, YueHua, China) 6 days a week, once daily, 10 minutes per session, for 4 weeks. The solution for atomization of the DC group is Dendrobii Caulis extracts. The prescription of the DC group contains Dendrobium (石斛) 35g. Subjects will be treated with hypromellose 0.3% w/v eye drops four times per day too. | Drug | Dendrobii Caulis (DC) group |
| TCM ultrasonic atomization treatment with Houttuynia Cordata (HC)The subjects will receive TCM ultrasonic atomization treatment with the ultrasonic nebulizer (WH-2000, YueHua, China) 6 days a week, once daily, 10 minutes per session, for 4 weeks. The solution for atomization of the HC group is Heartleaf Houttuynia Herb extracts. The prescription of the HC group contains Heartleaf Houttuynia Herb(魚腥草) 35g. Subjects will be treated with hypromellose 0.3% w/v eye drops four times per day too. | Drug | Houttuynia Cordata (HC) group |
| Placebo TCM ultrasonic atomization treatment (PA)The subjects will receive TCM ultrasonic atomization treatment with the ultrasonic nebulizer (WH-2000, YueHua, China) 6 days a week, once daily, 10 minutes per session, for 4 weeks. The solution for atomization of the PA group is low-concentration compound decoction (5%) same with the CD group. Subjects will be treated with hypromellose 0.3% w/v eye drops four times per day too. | Drug | Placebo Atomization (PA) group |
| Artificial Tears (AT)The subjects will receive lubricant eye drop (Hypromellose 0.3% w/v Eye Drops) four times per day only. | Drug | Artificial Tears (AT) group, Compound Decoction (CD) group, Dendrobii Caulis (DC) group, Houttuynia Cordata (HC) group, Placebo Atomization (PA) group |
Primary outcome
Change in the Ocular Surface Disease Index (OSDI)
Time frame: baseline to 4th week
The Ocular Surface Disease Index (OSDI) is a 12-item symptom frequency-based questionnaire. It is self-administered to assess DED-related symptoms and severity. The final OSDI score is calculated by dividing the product of the total sum of the score and 25 by the total number of answered questions, with a range from 0 to 100. The score reflects the severity of DED(normal: 0-12, mild: 13-22, moderate: 23-32, severe: >33).
Change in Non-invasive Tear Break-up Times (NIBUT)
Time frame: baseline to 4th week
The non-invasive tear break-up time (NIBUT) will be measured by the OCULUS Keratograph® 5M (Oculus, Wetzlar, Germany). Subjects will be instructed to keep their eyes on as much as possible during the examination. First and average NIBUT will be recorded by the machine accordingly. Shortening NIBUT(< 10 seconds) suggests instability of the tear film.
19 secondary outcomes
Change in Ocular Surface Disease Index (OSDI)
Time frame: 4 months
Change in symptom Assessment iN Dry Eye (SANDE, modified)
Time frame: 4 months
Change in 36-Item Short Form Health Survey (SF-36)
Time frame: 4 months
Change in the Work Productivity and Activity Impairment Questionnaire: General Health V2.0 (WPAI:GH)
Time frame: 4 months
Change in Non-Invasive Tear Break Up Times (NIBUT)
Time frame: 4 months
Changes in Tear Meniscus Height (TMH)
Time frame: 4 months
Changes in Bulbar Redness
Time frame: 4 months
Changes in Lipid Layer Thickness
Time frame: 4 months
Changes in Partial Blinking Rate
Time frame: 4 months
Changes in Meiboscore
Time frame: 4 months
Change in Tear Film Breakup Time (TBUT)
Time frame: 4 months
Change in Corneal and Conjunctival Fluorescein Staining
Time frame: 4 months
Change in Expressibility of Meibomian Glands in the Meibomian Glands Yielding Liquid Secretion (MGYLS) (the inferior eyelid)
Time frame: 4 months
Change in Quality of Expressed Meibum
Time frame: 4 months
Change in Lid Margin and Eyelash Abnormalities
Time frame: 4 months
Change in Tear Film Osmolarity (TFO)
Time frame: 4 months
Changes in Schirmer I test
Time frame: 4 months
Changes in Matrix metallopeptidase 9 (MMP-9)
Time frame: 4 months
Adverse events (AEs)
Time frame: 4 months
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 19 Mar 2026.
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A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
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)
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.
Kelvin KL Chong, MBChB principal investigator
Chinese University of Hong Kong
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TCM ultrasonic atomization treatment with herbal Compound Decoction (CD), TCM ultrasonic atomization treatment with Dendrobii Caulis (DC) and TCM ultrasonic atomization treatment with Houttuynia Cordata (HC) in people with Dry Eye Syndromes, run by Chinese University of Hong Kong at 4 sites in Hong Kong.
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 5 inclusion and 12 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 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Hong Kong. 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. Some participants in this study may receive a placebo. 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 in the Ocular Surface Disease Index (OSDI) (time frame: baseline to 4th week). The study lists 2 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 19 Mar 2026.