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Recruiting EARLY_Phase 1 NCT06451172

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

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Trial Parameters

Condition Bacterial Keratitis
Sponsor Eye & ENT Hospital of Fudan University
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 20
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-10-11
Completion 2024-10-01
Interventions
ASO

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Brief Summary

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

Inclusion Criteria: * 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. * Exists the potential of visual recovery by evaluation of ocular structure and function. * Subjects or their legal guardians voluntarily participate in this study, sign informed consent, good compliance and cooperation with follow-up visits. Exclusion Criteria: * 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. * Active eye infection (including but not limited to: blepharitis, infectious conjunctivitis, sclerotiti

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