About this trial
The purpose of this study is to evaluate the safety and efficacy of GP-asPNA for in vivo treatment of severe antibiotic resistant bacterial keratitis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The results of antimicrobial susceptibility testing in patients with bacterial keratitis showed multidrug-resistant bacterial infections, and the existing commercial antibiotics could not effectively control the disease.
Age over 18 years.
No systemic immune eye disease.
Good eyelid structure and blink function.
Disqualifiers
Lacrimal coating and blink function loss.
Schirmer's test result is less than 2mm for severe dry eye disease.
Pregnant and lactating women (pregnancy defined in this study as positive urine pregnancy test).
Currently is involved in clinical trials of other drugs or medical devices.
Trial design
Single group
Treatments tested in this trial
ASO
DrugAnticipated 20 Participants will receive a single group administered via eye drops in the study eye.
Treatment groups
Trial outcomes
Primary outcomes
Bacteria testing outcome of the intervention eye
Assess the efficacy of bacteria clearance based on RNA sequencing data using techniques such as ELISA and PCR. For instance, real-time polymerase chain reaction (PCR) is utilized to identify 16S rRNA in corneal biopsy samples.
Ophthalmic therapeutic effect of ASO eye drops
Measure the decrease in size, depth and infiltrate of the ulcer in millimeters by slit lamp biomicroscopy.
Secondary outcomes
Visual improvement compared with baseline
Judge the visual recovery progress according to visual examination results on day 1,3±1,7±1,14±2,30±2,90±5.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Eye & ENT Hospital of Fudan University
Lead sponsor
Soochow University
Collaborator