Individualized Chinese Medicine for the Treatment of Symptoms Associated with Diabetes-induced Dry Eye Disease: A Single-case Randomized Controlled Trial

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR1900002461

Enrollment

Unknown

Registered

2019-07-13

Start date

2019-08-12

Completion date

Unknown

Last updated

2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes-induced Dry Eye Disease

Interventions

Experimental group:TCM individualized treatment

Control group:Placebo

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. patients with confirmed diabetes-induced Dry Eye Disease; 2. comply with TCM syndrome differentiation standards; 3. aged 18 to 75 years; 4. accepted the survey voluntarily and signed informed consent; 5. ability to return for study visits.

Exclusion criteria

Exclusion criteria: 1. women who were pregnant or breastfeeding; 2. patients with any ocular surface disease, scarring, acute ocular infection, blepharitis, and an unwillingness to discontinue contact lens wear during the study; 3. receive any eye surgery within 3 months; 4. history of diseases that affect vital organs, including heart, liver, and kidney; 5. mental disorder; 6. participated in other clinical trials in recent 3 months.

Design outcomes

Primary

Measure	Time frame
corneal fluorescein staining;TCM syndrome score;tear film break-up times;tears meniscus height;Ocular Surface Disease Index score;Meibomian gland loss rate;Schirmer tests;	—

Countries

China

Contacts

Public ContactXuejing Lu

xgl214@126.com+86 18908178510

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026