Observation on the effect of Zhangyanming tablets combined with fluorometholone eye drops (0.02%) and human epidermal growth factor eye drops in the treatment of moderate and severe dry eye disease

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2024000386

Enrollment

Unknown

Registered

2024-09-05

Start date

2023-04-27

Completion date

Unknown

Last updated

2024-09-16

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

Conditions

Dry eye disease

Interventions

Observation group:Treated with ZYMT on the basis of the control group. 2 tablets each time, 3 times a day.

Control group:Fluorometholone eye drops (0.02%) (5 mL: 1 mg) 1-2 drops each time twice a day (both eyes)

Human epidermal growth factor eye drops (4 mL: 40000 IU/ piece) 1~2 drops each time twice a day (for both eyes).

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria of moderate and severe dry eye in Western medicine; (Note: In the Clinical Application Guide of Traditional Chinese Medicine for the Treatment of Dry Eye (2021) the Chinese patent medicine recommended for the treatment of dry eye is not recommended for treatment according to TCM dialectical classification so TCM dialectical classification is not set in this study) (2) Male and female aged 18-75; (3)Cooperate with the questionnaire and related tests and OSDI score >=13 points; (4) The patient volunteered to take the test and signed the informed consent.

Exclusion criteria

Exclusion criteria: (1) Known or suspected allergic history or serious adverse reaction to the test drug and its excipients or allergic constitution; (2) Patients with Sjogren's syndrome connective tissue disease systemic rheumatic immune disease and malignant tumor; (3) Patients with other eye diseases such as ocular chemical injury eyelid defect glaucoma keratoconjunctivitis obstruction of lacrimal passage and extensive scar of palpebral conjunctivitis; (4) People who are allergic to drugs or have drug contraindications; (5) pregnant lactating or mentally ill patients; (6) No drugs related to dry eye treatment were taken 2 weeks before enrollment. (7) Other situations that the researcher thinks should not be included in this observation.

Design outcomes

Primary

Measure	Time frame
Comprehensive effect of dry eye;	—

Secondary

Measure	Time frame
break-up time, BUT;Systemic symptom score;Schirmer I Test;Ocular surface disease index score, OSDI;	—

Countries

China

Contacts

Public ContactDahui Ma

Shenzhen Eye Hospital(SZEH)

bensma@163.com+86 132 6502 1391

Outcome results

None listed

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