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

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • ASO

    Drug

    Anticipated 20 Participants will receive a single group administered via eye drops in the study eye.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: ASO Single GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
90 Days
2

Ophthalmic therapeutic effect of ASO eye drops

Measure the decrease in size, depth and infiltrate of the ulcer in millimeters by slit lamp biomicroscopy.

Time frame
90 Days

Secondary outcomes

1

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.

Time frame
90 Days

Other outcomes

Sponsors and contacts

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