Dry EyeNCT06818487
Ganyan-1 in Dry Eye
A study testing Ganyan1, Sodium Hyaluronate and 1/2Ganyan1 in people with Dry Eye and TCM, run by Beijing Tongren Hospital.
Trial summary
Ganyan -1 for the patients with dry eye Read more about this study
- Who is it for?
- Ages 18 to 70 years
- What is being tested?
- Ganyan1, Sodium Hyaluronate and 1/2Ganyan1
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 219 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age >=18 and Age <=70, complaint of DED symptoms for 6 months or longer at screening.
- 3. ocular surface disease index (OSDI) score of 25 or higher. 4. tear film breakup time (TFBUT) of 5 seconds or less. 5. Schirmer I test without anesthesia of 5 mm or more at 5 minutes. 6. CFS score of 4 or higher.
Who cannot join
- History systemic autoimmune diseases and ocular/periocular malignancy.
- Clinically relevant slitlamp findings or abnormal lid anatomy.
- Active ocular allergies and active infection.
- Pregnant or lactating women.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Ganyan-1 in Dry Eye: A Randomized Clinical Trial
Ganyan -1 for the patients with dry eye
Read the detailed description
Objective: Ganyan-1 for the patients with dry eye Methods: The investigators enrolled 219 patients at Beijing Tongren Hospital. Patients completed questionnaires at baseline, week2, week4, week8, week12, and week16.
- Being tested
- Ganyan1, Sodium Hyaluronate, 1/2Ganyan1, Placebo
- Keywords
- Dry eye, TCM, RCT
- 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.
Ganyan1Drug
During the treatment period, participants will receive the following Chinese herbal granules, including Chrysanthemum, Dendrobium, Salvia miltiorrhiza, Gypsum Fibrosum, and Goji berries, administered twice daily at a dose of 10 g per time for a duration of 4 weeks.
Sodium HyaluronateDrug
Participants received 0.1% sodium hyaluronate eye drop
1/2Ganyan1Drug
During the treatment period, participants will receive the following Chinese herbal granules, including Chrysanthemum, Dendrobium, Salvia miltiorrhiza, Gypsum Fibrosum, and Goji berries, administered twice daily at a dose of 5 g per time for a duration of 4 weeks.
PlaceboDrug
Participants will receive the following placebo Chinese herbal granules, administered twice daily at a dose of 10 g per time for a duration of 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Ganyan1 | Experimental | Not described Receives: Drug: Ganyan1; Drug: Sodium Hyaluronate |
| 1/2Ganyan1 | Experimental | Not described Receives: Drug: Sodium Hyaluronate; Drug: 1/2Ganyan1 |
| Placebo | Placebo comparator | Not described Receives: Drug: Sodium Hyaluronate; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
OSDI
The Ocular Surface Disease Index (OSDI) includes 12 questions grouped by poor symptoms and visual disturbance (light sensitivity, eyes feel gritty, painful or sore eyes, blurred vision or poor vision); visual function/tasks (problems when reading, driving at night, working on a computer or watching TV); and environmental questions (problems in windy conditions, places/ areas with low humidity or areas that are air conditioned). The scores range from 0 to 100. On the basis of the score, the patient's symptoms can be categorized as normal (0-12), mild dry eye (13-22), moderate dry eye (23-32), or severe dry eve (33-100).
Measured: Baseline, week 2, 4, 8, 12 and 16
Secondary outcomes (6)
TBUT
Tear breakup time (TBUT) is a clinical test used to assess for evaporative dry eye disease. To measure TBUT, fluorescein is instilled into the patient's tear film and the patient is asked not to blink while the tear film is observed under a broad beam of cobalt blue illumination. The TBUT is recorded as the number of seconds that elapse between the last blink and the appearance of the first dry spot in the tear film, as seen in this progression of these slit lamps' photos over time. A TBUT under 10 seconds is considered abnormal.
Measured: Baseline, week 2, 4, 8, 12 and 16
Schirmer
The Schirmer test is objectively used to measure tear secretion without anesthetized. A healthy eye should wet more than 10 mm of the standard filter strip in 5 minutes. The travel rate along the test strip is proportional to the tear production rate.
Measured: Baseline, week 2, 4, 8, 12 and 16
SF-36
36-Item Short Form Health Survey (SF36) measures quality of life on the basis of eight dimensions or concepts that are frequently used in health studies. These eight dimensions are estimated from eight subscales that examine physical functioning (SF36-PF), role functioning-physical (SF36-RP), bodily pain (SF36-BP), general health (SF36- GH), vitality (SF36-VT), social functioning (SF36-SF), role functioning-emotional (SF36-RE), mental health (SF36-MH) and reported health transition (SF36-HT). Item responses were ranaina from 0 (best) to 100 (worst), with hiaher scores are equivalent to areater severity of better quality of life.
Measured: Baseline, week 2, 4, 8, 12 and 16
SAS
The SAS is a 20-item self-report instrument designed to assess anxiety symptoms in clinical and research settings. This scale ranges from 20 to 80, with lower scores indicating better self-reported mental health and fewer anxiety symptoms.
Measured: Baseline, week 2, 4, 8, 12 and 16
SDS
Medical Outcomes from study 20-Item Self-Rating Depression Scale. This scale range is 0-100 with lower scores indicating better self-reported mental health.
Measured: Baseline, week 2, 4, 8, 12 and 16
OQAS II
Medical Outcomes from the OQAS II Visual Quality Assessment The OQAS II measures visual quality using several optical parameters. Scores are generated based on metrics like the Modulation Transfer Function (MTF) and Objective Scatter Index (OSI). The scale ranges from 0-100, with lower scores indicating better optical quality and fewer distortions. Change is calculated as the score at follow-up time points (e.g., post-treatment or surgery) minus the baseline score.
Measured: Baseline, week 2, 4, 8, 12 and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 219 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818487
- Sponsor's protocol ID
- DED_TCM_2024
- Status last verified
- Dec 2024
- First submitted
- 5 Feb 2025
- Last updated
- 25 Jun 2025
- 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 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ganyan-1 in Dry Eye: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06818487
- Acronym / sponsor ID
- DED_TCM_2024
- Keywords
- Dry eye, TCM, RCT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 219 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 10 Feb 2025 (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.
Ganyan -1 for the patients with dry eye
Detailed description
Objective: Ganyan-1 for the patients with dry eye Methods: The investigators enrolled 219 patients at Beijing Tongren Hospital. Patients completed questionnaires at baseline, week2, week4, week8, week12, and week16.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ganyan1 | Experimental | Drug: Ganyan1, Drug: Sodium Hyaluronate |
| 1/2Ganyan1 | Experimental | Drug: Sodium Hyaluronate, Drug: 1/2Ganyan1 |
| Placebo | Placebo comparator | Drug: Sodium Hyaluronate, Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Age >=18 and Age <=70, complaint of DED symptoms for 6 months or longer at screening.
- 3. ocular surface disease index (OSDI) score of 25 or higher. 4. tear film breakup time (TFBUT) of 5 seconds or less. 5. Schirmer I test without anesthesia of 5 mm or more at 5 minutes. 6. CFS score of 4 or higher.
Key exclusion criteria (4 listed)
- History systemic autoimmune diseases and ocular/periocular malignancy.
- Clinically relevant slitlamp findings or abnormal lid anatomy.
- Active ocular allergies and active infection.
- Pregnant or lactating women.
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 |
|---|---|---|
| Ganyan1During the treatment period, participants will receive the following Chinese herbal granules, including Chrysanthemum, Dendrobium, Salvia miltiorrhiza, Gypsum Fibrosum, and Goji berries, administered twice daily at a dose of 10 g per time for a duration of 4 weeks. | Drug | Ganyan1 |
| Sodium HyaluronateParticipants received 0.1% sodium hyaluronate eye drop | Drug | 1/2Ganyan1, Ganyan1, Placebo |
| 1/2Ganyan1During the treatment period, participants will receive the following Chinese herbal granules, including Chrysanthemum, Dendrobium, Salvia miltiorrhiza, Gypsum Fibrosum, and Goji berries, administered twice daily at a dose of 5 g per time for a duration of 4 weeks. | Drug | 1/2Ganyan1 |
| PlaceboParticipants will receive the following placebo Chinese herbal granules, administered twice daily at a dose of 10 g per time for a duration of 4 weeks. | Drug | Placebo |
Primary outcome
OSDI
Time frame: Baseline, week 2, 4, 8, 12 and 16
The Ocular Surface Disease Index (OSDI) includes 12 questions grouped by poor symptoms and visual disturbance (light sensitivity, eyes feel gritty, painful or sore eyes, blurred vision or poor vision); visual function/tasks (problems when reading, driving at night, working on a computer or watching TV); and environmental questions (problems in windy conditions, places/ areas with low humidity or areas that are air conditioned). The scores range from 0 to 100. On the basis of the score, the patient's symptoms can be categorized as normal (0-12), mild dry eye (13-22), moderate dry eye (23-32), or severe dry eve (33-100).
6 secondary outcomes
TBUT
Time frame: Baseline, week 2, 4, 8, 12 and 16
Schirmer
Time frame: Baseline, week 2, 4, 8, 12 and 16
SF-36
Time frame: Baseline, week 2, 4, 8, 12 and 16
SAS
Time frame: Baseline, week 2, 4, 8, 12 and 16
SDS
Time frame: Baseline, week 2, 4, 8, 12 and 16
OQAS II
Time frame: Baseline, week 2, 4, 8, 12 and 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Ganyan1, Sodium Hyaluronate and 1/2Ganyan1 in people with Dry Eye and TCM, run by Beijing Tongren Hospital.
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 2 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: opening soon, as of the sponsor's last update on 25 Jun 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dong Wu, Doctor (8613810988682, wudong0120@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OSDI (time frame: Baseline, week 2, 4, 8, 12 and 16). 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 25 Jun 2025.