Novel Antisense Oligonucleotide Eye Drops for Treating Antibiotic-Resistant Bacterial Keratitis

ConditionsBacterial Keratitis Antibiotic-resistant Bacteria Infections, Bacterial Corneal Diseases Eye Diseases Vision Disorders Sensation Disorders Blindness Antisense Peptide Nucleic Acid Antibacterial Therapy

Trial statusRecruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorEye & ENT Hospital of Fudan University

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

Qualifiers

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

Treatments tested in this trial

Treatment groups

20 Participants

are divided into 1 treatment group

Sponsors and collaborators

Eye & ENT Hospital of Fudan University

Lead sponsor

Soochow University

Collaborator

Source ClinicalTrials.gov