Effect of Traditional Chinese Medicine on Basic Tear Secretion and Tear Cytokines in Patients With Dry Eye Disease

December 3, 2021 updated by: China Medical University Hospital

Pilot Study on The Effect of Traditional Chinese Medicine on Basic Tear Secretion and Tear Cytokines in Patients With Dry Eye Disease

This is a single center, randomized, single-blind, controlled pilot study of CJDHW plus JWXYS as a complementary therapy to treat dry eye disease during a 12-week period. The investigators intend to enroll 60 subjects aged between 20 and 75 years old (treatment group(N=30); controlled group(N=30)). Treatment group will be treated with artificial tears combined with TCM, while control group will use artificial tears only. The aim of this study is to explore the efficacy of TCM for dry eye disease.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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

Dry eye disease (DED) is a chronic inflammatory disease. In severe cases, it may cause corneal ulcers, blurred vision, and even blindness. The prevalence of DED is about 30% in Taiwan. With the popularity of technological products and prolonged average life expectancy, the incidence of dry eye disease is increasing at a rate of 10% per year in Taiwan. However, treatment of DED mainly focuses on symptom relief in modern medicine. It is a difficult problem to improve the pathological state of patients with DED. Hence, there is an urgent need for a more effective and safe method of treating this disease.

Chi-Ju-Di-Huang-Wan (CJDHW) is commonly used in traditional Chinese medicine (TCM) for eye diseases. However, current research shows that use CJDHW alone to treat dry eye is less effective for tear secretion, which may be related to the unimproved inflammation state. Ligustilide and ferulic acid, which own significant anti-inflammatory effects, are the effective ingredients of Jia-Wei-Xiao-Yao-San (JWXYS). Many studies have demonstrated that JWXYS can reduce serum TNF-α and IFN-γ levels in patients with DED. Therefore, the investigators choose to use CJDHW plus JWXYS for treatment in this study.

This is a single center, randomized, single-blind, controlled pilot study of CJDHW plus JWXYS as a complementary therapy to treat dry eye disease during a 12-week period. The investigators intend to enroll 60 subjects aged between 20 and 75 years old (treatment group(N=30); controlled group(N=30)). Treatment group will be treated with artificial tears combined with TCM, while control group will use artificial tears only. The evaluation will be conducted on 1st, 4th, 8th,12th week. Primary endpoints include Schirmer's test and non-invasive tear film breakup time(NiBUT); secondary endpoints include tear meniscus height, meibomian gland loss rate, tear cytokines and matrix metalloproteinases (MMPs) levels and Ocular Surface Disease Index (OSDI).

The aim of this study is to explore the efficacy and possible mechanism of TCM for DED.

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 (Anticipated)

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.
60

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.
  • Phase 2

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 Locations

  • Taiwan
      • Taichung, Taiwan, 404332
        • Recruiting
        • China Medical University Hospital
        • Contact:
        • Principal Investigator:
          • Hui-Ju Lin, PhD
        • Sub-Investigator:
          • Hung-Jen Lin, PhD

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

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 20 and 75 years.
  • A confirmed diagnosis of DED by ophthalmologists.
  • Willing to sign informed consent form.

Exclusion Criteria:

  • With autoimmune diseases.
  • Pregnant or lactating.
  • Underwent transplant surgery and got graft-versus-host disease in the past.
  • With eye infection, inflammation, trauma, or underwent eye surgery in the past three months.
  • Underwent dry eye intense pulse light treatment in the past three months.
  • Underwent other treatments including TCM drugs or acupuncture in the past month or during the trial.
  • Persistent in taking diuretics, antidepressant, antihistamines and anticholinergics.
  • Combined treatment with autologous serum, cyclosporine or steroid eye drops during the trial.
  • Took fish oil or vitamin D during the trial.

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: Single

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.
Active Comparator: conventional treatment
Patients in this group will be given conventional treatment including Artelac® Eye Drops (1-2 drips each time, every 4 hours) and Vidisic® Gel (1 drip each time, at bedtime) for 12 weeks.
Drug: Methylhydroxypropylcellulose
1-2 drips each time, every 4 hours, for 12 weeks.
Other Names:
  • Artelac® Eye Drops
Drug: Carbomer
1 drip each time, at bedtime, for 12 weeks.
Other Names:
  • Vidisic® Gel
Experimental: conventional treatment + TCM
Patients in this group will be given conventional treatment and traditional Chinese medicine (6.0g twice daily) for 12 weeks.
Drug: Methylhydroxypropylcellulose
1-2 drips each time, every 4 hours, for 12 weeks.
Other Names:
  • Artelac® Eye Drops
Drug: Carbomer
1 drip each time, at bedtime, for 12 weeks.
Other Names:
  • Vidisic® Gel
Drug: TCM Formula
6.0g Chi-Ju-Di-Huang-Wan plus 6.0g Jia-Wei-Xiao-Yao-San, 6.0g twice daily for 12 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
Schirmer's Test
Time Frame: Change from baseline Schirmer's Test at week 4, week 8 and week 12
Uses paper strips inserted into the eye for 5 minutes to measure the production of tears. Both eyes are tested at the same time.
Change from baseline Schirmer's Test at week 4, week 8 and week 12
Non-invasive Tear Film Break-up Time (NiBUT)
Time Frame: Change from baseline NiBUT at week 4, week 8 and week 12
Measured by Antares Corneal Topography.
Change from baseline NiBUT at week 4, week 8 and week 12

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
Tear Meniscus Height
Time Frame: Change from baseline Tear meniscus height at week 4, week 8 and week 12
Measured by Antares Corneal Topography.
Change from baseline Tear meniscus height at week 4, week 8 and week 12
Meibomian Gland Loss Rate
Time Frame: Change from baseline Meibomian gland loss rate at week 4, week 8 and week 12
Measured by Antares Corneal Topography.
Change from baseline Meibomian gland loss rate at week 4, week 8 and week 12
Tear Cytokines
Time Frame: Change from baseline Tear cytokines at week 4, week 8 and week 12
Change from baseline Tear cytokines at week 4, week 8 and week 12
Ocular Surface Disease Index (OSDI)
Time Frame: Change from baseline OSDI at week 4, week 8 and week 12
Change from baseline OSDI at week 4, week 8 and week 12

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.
China Medical University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hui-Ju Lin, PhD, China Medical University 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 (Actual)

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.
March 16, 2021

Primary Completion (Anticipated)

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.
May 31, 2022

Study Completion (Anticipated)

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.
May 31, 2022

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).
March 3, 2021

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.
March 3, 2021

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.
March 5, 2021

Study Record Updates

Last Update Posted (Actual)

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.
December 6, 2021

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.
December 3, 2021

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, 2021

More Information

Terms related to this study

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.
  • CMUH109-REC2-169

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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