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0.1% tacrolimus (FK506) in the treatment of moderately severe dry eye clinical efficacy evaluation

0.1% tacrolimus (FK506) in the treatment of moderately severe dry eye clinical efficacy evaluation

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPQ-15006773
Enrollment
Unknown
Registered
2015-03-27
Start date
2015-07-20
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

dry eye

Interventions

Glucocorticoid treatment group:0.5% of chlorine for spilt + 0.1% sodium hyaluronate Twice a day for 30 days
combining therapy group:0.1%FK506+0.5%Chloromethyl+0.1%Sodium hyaluronate Twice a day, every time a drop, 30 days

Sponsors

Eye Institute of Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. participation in the clinical research, voluntary and sign a consent form; 2. gender unlimited, ages 18 to 70 years of age; 3. for patients (the following is common in patients with other patients according to the condition of clinical practical give priority to): Patients with moderately severe dry eye: (1) symptoms of selected indicators: dry eye questionnaire moderately severe dry eye (2) signs of selected indicators: frequent or permanent existence of discomfort, conjunctival congestion (+), the conjunctival fluorescence staining (+ +), fluorescence staining (+) of the cornea, filamentous keratitis, tears river height decreased obviously, frequent MDGS, BUT 5 s or less, schirmer test 5 mm/min or less, may be accompanied by trichiasis, keratinization, symblepharon; (3) possible disease:, Steven Johnson, sjogren syndrome, chronic graft versus host disease in patients with moderately severe dry eye, etc. 4. the study choice: patients' eyes are checked, for the signs and symptoms score high risk of eye eye;Such as integral equal, corneal fluorescein staining for the study of the heavier with eye, such as eyes fluorescein staining degree equal to take the right eye eye for research; 5. test in 2 weeks did not attend any other drug clinical trials; 6. don't use other medications, or use other drugs but has stopped for more than 2 weeks.

Exclusion criteria

Exclusion criteria: Exclusion criteria: Every one of the following circumstances, not as the case: (1) the test allergy to any ingredient in the drug; (2) pregnant or lactating women or recently have fertility planners; (3) the clinical examination for fungi, bacteria, Angle, conjunctivitis in active patients; (4) with other conjunctiva, cornea and iris obvious pathological changes; (5) with serious heart, cerebrovascular, liver, kidney and hematopoietic system, severe primary disease; (6) nearly six months have eye surgery within or outside of the injured eye; (7) postmenopausal hormone replacement therapy; (8) lacrimal point embolism therapy nearly 1 month; (9) high intraocular pressure of patients with glaucoma or seen; (10) may affect the outcome of treatment, such as systemic steroid hormones and immunosuppressive therapy); (11) experiments cannot stop wearing corneal contact lens; (12) patients with systemic or ocular long-term drug use may affect the research assessment; (13) during the test is no guarantee that drugs according to the requirements and with the visitor.

Design outcomes

Primary

MeasureTime frame
dry eye questionnaire;conjunctival nipples;tear meniscus height;TBUT;

Secondary

MeasureTime frame
corneal opacity;corneal neovascularization;corneal edema;schirmer I test;

Countries

China

Contacts

Public ContactZuguo Liu
zuguoliu@xmu.edu.cn+86 18959289999

Outcome results

None listed

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