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A multi-center clinical study on the safety and efficacy of cyclosporine eye drops (II) in the treatment of dry eye

A multi-center clinical study on the safety and efficacy of cyclosporine eye drops (II) in the treatment of dry eye

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070695
Enrollment
Unknown
Registered
2023-04-20
Start date
2023-05-20
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

dry eye disease

Interventions

experimental group:The trial drug was used twice

Sponsors

Xiamen Eye Center of Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >= 16 years old, gender unlimited; 2. Patients complain of dry eyes, and EDS (Eye Dryness Score) refers to dry eyes score (VAS evaluation of 0-100 points) >=40 points; 3. Chinese Dry eye Questionnaire >=7 points 4. FBUT=1 point 6. Volunteer to participate in the study and sign a written informed consent

Exclusion criteria

Exclusion criteria: 1. Have an uncontrolled active eye disease that may affect the reliability of observations in this clinical trial, e.g Combined with infectious conjunctival keratitis, uveitis, nasolacrimal duct obstruction, intraocular infection, etc. 2. Fluorescein corneal staining completely fused into patches or the appearance of filamentous keratitis 3. Patients who used topical cyclosporins within 2 weeks 4. Patients with a history of allergies to any component of drugs or tests (e.g., cyclosporine, luciferin, etc.) intended for use in the study 5. Patients with exophthalmos or incomplete eyelid closure 6. Patients with uncontrolled systemic disease or for other reasons deemed unsuitable for admission to the study by the investigator 7. Pregnant women, lactating women, women of childbearing age who do not take effective contraceptive measures, or plan to conceive during the test period, and the pregnancy test results are positive before the test; 8. Patients who were unwilling to stop wearing contact lenses during the study 9. Patients who have participated in or are participating in other clinical trials within 3 months

Design outcomes

Primary

MeasureTime frame
Incidence of adverse reactions;

Secondary

MeasureTime frame
EDS at 24 weeks;

Countries

China

Contacts

Public ContactZuguo Liu

Xiamen Eye Center of Xiamen University

zuguoliu@xmu.edu.cn+86 13696984489

Outcome results

None listed

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