Ganyan-1 in Dry Eye

June 19, 2025 updated by: Beijing Tongren Hospital

Ganyan-1 in Dry Eye: A Randomized Clinical Trial

Ganyan -1 for the patients with dry eye

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
219

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

  1. History systemic autoimmune diseases and ocular/periocular malignancy.
  2. Clinically relevant slitlamp findings or abnormal lid anatomy.
  3. Active ocular allergies and active infection.
  4. Pregnant or lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Sodium Hyaluronate
Participants received 0.1% sodium hyaluronate eye drop
Drug: Placebo
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.
Experimental: Ganyan1
Drug: Ganyan1
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.
Drug: Sodium Hyaluronate
Participants received 0.1% sodium hyaluronate eye drop
Experimental: 1/2Ganyan1
Drug: Sodium Hyaluronate
Participants received 0.1% sodium hyaluronate eye drop
Drug: 1/2Ganyan1
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Baseline, week 2, 4, 8, 12 and 16

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
TBUT
Time Frame: Baseline, week 2, 4, 8, 12 and 16
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.
Baseline, week 2, 4, 8, 12 and 16
Schirmer
Time Frame: Baseline, week 2, 4, 8, 12 and 16
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.
Baseline, week 2, 4, 8, 12 and 16
SF-36
Time Frame: Baseline, week 2, 4, 8, 12 and 16
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.
Baseline, week 2, 4, 8, 12 and 16
SAS
Time Frame: Baseline, week 2, 4, 8, 12 and 16
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.
Baseline, week 2, 4, 8, 12 and 16
SDS
Time Frame: Baseline, week 2, 4, 8, 12 and 16
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.
Baseline, week 2, 4, 8, 12 and 16
OQAS II
Time Frame: Baseline, week 2, 4, 8, 12 and 16
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.
Baseline, week 2, 4, 8, 12 and 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Tongren Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DED_TCM_2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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