Novel Antisense Oligonucleotide Eye Drops for Treating Antibiotic-Resistant Bacterial Keratitis
China20 participantsStarted 2023-10-11
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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, sclerotitis, endophthalmitis) in target eye or contralateral eye within 30 days prior to enrollment.
* Ocular surface malignant tumor.
* A history of allergic reaction or allergy to sodium luciferin, allergy to protein products used for treatment or diagnosis, allergy to ≥ 2 drugs or non-drug factors, or current allergic disease.
* current in an infectious disease requiring oral, intramuscular or intravenous administration.
* Patients with systemic immune diseases.
* Any uncontrolled clinical problems …