NCT04785261

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

March 16, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

December 6, 2021

Status Verified

December 1, 2021

Enrollment Period

1.2 years

First QC Date

March 3, 2021

Last Update Submit

December 3, 2021

Conditions

Dry Eye DiseaseDry Eye SyndromesDry Eye

Outcome Measures

Primary Outcomes (2)

  • Schirmer's Test

    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)

    Measured by Antares Corneal Topography.

    Change from baseline NiBUT at week 4, week 8 and week 12

Secondary Outcomes (4)

  • Tear Meniscus Height

    Change from baseline Tear meniscus height at week 4, week 8 and week 12

  • Meibomian Gland Loss Rate

    Change from baseline Meibomian gland loss rate at week 4, week 8 and week 12

  • Tear Cytokines

    Change from baseline Tear cytokines at week 4, week 8 and week 12

  • Ocular Surface Disease Index (OSDI)

    Change from baseline OSDI at week 4, week 8 and week 12

Study Arms (2)

conventional treatment

ACTIVE COMPARATOR

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: MethylhydroxypropylcelluloseDrug: Carbomer

conventional treatment + TCM

EXPERIMENTAL

Patients in this group will be given conventional treatment and traditional Chinese medicine (6.0g twice daily) for 12 weeks.

Drug: MethylhydroxypropylcelluloseDrug: CarbomerDrug: TCM Formula

Interventions

MethylhydroxypropylcelluloseDRUG

1-2 drips each time, every 4 hours, for 12 weeks.

Also known as: Artelac® Eye Drops
conventional treatmentconventional treatment + TCM
CarbomerDRUG

1 drip each time, at bedtime, for 12 weeks.

Also known as: Vidisic® Gel
conventional treatmentconventional treatment + TCM
TCM FormulaDRUG

6.0g Chi-Ju-Di-Huang-Wan plus 6.0g Jia-Wei-Xiao-Yao-San, 6.0g twice daily for 12 weeks.

conventional treatment + TCM

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, 404332, Taiwan

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

carbomer

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Hui-Ju Lin, PhD

    China Medical University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Teng-I Huang, MD

CONTACT

+886-4-22052121d31204@mail.cmuh.org.tw

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2021

First Posted

March 5, 2021

Study Start

March 16, 2021

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

December 6, 2021

Record last verified: 2021-12

Locations

TW(1)