Au-Ag-Cu2O NG With PTT Anti Drug-resistant Microbial Keratitis

NCT05268718 | Unknown Early Phase 1

• 1 other identifier: 2021-0635
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study was conducted to evaluate the efficacy and safety of gold-silver cuprous oxide composite nanogels combined with photothermal therapy system in the treatment of severe drug-resistant bacterial keratitis ineffective by traditional antibiotic treatment in human eyes, and to provide translational applications. Based on the clinical evidence, a more effective and safe innovative treatment plan for corneal diseases has been developed.

Conditions

Keratitis, Ulcerative; Antibiotic Resistance, Microbial; Photothermal Therapy

Keywords

Photothermal Therapy; Keratitis, Ulcerative; Antibiotic Resistance, Microbial

Outcome Measures

Primary Outcomes (2)

• Anterior segment photography

  corneal edema, keratohelcosis, hppopyon

  1 month

• confocal microscopy

  fungal hyphae in corneal surface

  1 month

Secondary Outcomes (2)

• eye pressure

  1 month

• visual acuity

  1 month

Study Arms (3)

Nanogel photothermal therapy

EXPERIMENTAL

After the subjects were enrolled in the study, the eyes were coated with Au-Ag-Cu2O nano-gel once (the concentration was 26.4μg/mL, the dosage was suitable to cover the ulcer surface evenly, and the dosage was recorded). Combined with mdl-n-808-10w near-infrared laser (China changchun new industry photoelectric technology) combined with photothermal therapy (laser wavelength 808 nm, power 1.5W/cm2, temperature controlled at 40℃, lasting 10min)

Drug: Hollow gold and silver alloy cuprous oxide shell nano-shell hydrogel

Voriconazole eye drops

ACTIVE COMPARATOR

Voliconazole eye drops (once in half an hour) were also used in the control group.

Drug: Voriconazole eye drops

Normal saline

PLACEBO COMPARATOR

Normal saline eye drops (once in half an hour) were also used in the control group.

Other: Normal saline

Interventions

Hollow gold and silver alloy cuprous oxide shell nano-shell hydrogel DRUG

Hollow gold and silver alloy cuprous oxide shell nano-shell hydrogel was excited by NIR laser to release functional silver ions, copper ions and ROS.

Also known as: Au-Ag-Cu2O nano-gel

Nanogel photothermal therapy

Voriconazole eye drops DRUG

Voriconazole eye drops (1%) were administrated to infectious eye very frequently (once half an hour)

Also known as: VRC

Voriconazole eye drops

Normal saline OTHER

To be placebo, normal saline were administrated to infectious eye

Also known as: NS

Normal saline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The monocular cases of severe infectious keratitis admitted to our center were diagnosed as fungal keratitis according to their medical history, physical signs and surface secretions smear examination of corneal ulcer lesions (severe was defined as subjects with visual acuity \< 0.15, deep stromal infiltration or involvement diameter \>2mm, with extensive infiltration around or with extensive suppuration)
• After more than 2 weeks of active treatment with antibiotics, there was no effect
• The researchers communicated with the subjects in detail, and the subjects cooperated well and they voluntarily participated and signed informed consent

You may not qualify if:

• Allergic to the drug in this test.
• Pregnant and lactating women.
• The medical history suggests serious heart, lung, liver, kidney dysfunction.
• Patients with other factors that would affect the results of this result.
• No signed informed consent.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Corneal Ulcer

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Eye Infections; Infections; Keratitis; Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ke Yao, MD

  Second Affiliated Hospital of Zhejiang University School of Medicine

  STUDY DIRECTOR

Central Study Contacts

Yue Qiao, PhD

CONTACT

+8619818504850; qiaosensei@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: March 7, 2022
• Study Start: August 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: July 1, 2024
• Last Updated: March 7, 2022

Record last verified: 2021-08

Locations

CN (1)