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A randomized, blind, and positive controlled clinical trial to evaluate the safety and efficacy of 1% voriconazole eye drops in the treatment of fungal keratitis

A randomized, blind, and positive controlled clinical trial to evaluate the safety and efficacy of 1% voriconazole eye drops in the treatment of fungal keratitis

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033968
Enrollment
Unknown
Registered
2020-06-19
Start date
2020-06-22
Completion date
Unknown
Last updated
2020-06-22

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

Conditions

Fungal keratitis

Interventions

experimental group:1% voriconazole eye drops
control group :Natamycin eye drops

Sponsors

Shenyang Sinqi Eye Hospital Co., Ltd
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-65 years old, regardless of gender; 2. Patients with typical history, symptoms and signs of fungal keratitis, 3 points <= eye score <= 8 points; 3. Patients identified as fungal infection by laboratory examination (fungal hyphae can be seen by corneal scraping microscopy, fungal hyphae can be seen by confocal microscopy, and any one of the two items can be positive); 4. The subjects did not receive antifungal drug treatment; 5. Patients who voluntarily participated in the trial and signed the written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with the longest diameter line 6mm; patients with impending or existing corneal perforation and prominent posterior elastic layer; 2. Patients with bacterial infection were found by corneal scraping; 3. Patients with acute and chronic dacryocystitis; 4. Patients with dystrophic corneal ulcer and incomplete eyelid closure; 5. Patients who need to use steroid hormone or other immunosuppressants locally or in the whole body; 6. Patients with monocular or monocular vision; 7. Patients with corneal ulcer in both eyes; 8. Patients who are allergic to the drugs used in this study; 9. Patients with immune system diseases, cardiopulmonary insufficiency, liver and kidney dysfunction, and diabetes history; 10. The researcher judges the patients with abnormal laboratory examination indexes and clinical significance; 11. Patients with corneal surgery history; 12. Pregnancy (defined as positive pregnancy test), lactating women or patients with family planning within the past six months; 13. Patients who have participated in other clinical trials in the past 3 months; 14. Patients who are not considered suitable for the clinical trial.

Design outcomes

Primary

MeasureTime frame
Effective rate of clinical treatment at the 12th week;Changes of ocular score relative to baseline at each follow-up point;

Secondary

MeasureTime frame
Effective rate of clinical treatment at the fourth, sixth and eighth week;Best corrected vision;Intraocular pressure;routine blood test;Hepatorenal function;Urine routine + microscopic examination of urine sediment;Urinary pregnancy;

Countries

China

Contacts

Public ContactXiaonan Sun

Shenyang Xingqi Eye Hospital Co., Ltd

13897913977@163.com+86 13897913977

Outcome results

None listed

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