New eye drops to treat antibiotic-resistant bacterial keratitis
Novel Antisense Oligonucleotide Eye Drops for Treating Antibiotic-Resistant Bacterial Keratitis
This study is testing new eye drops for adults with severe antibiotic-resistant bacterial keratitis to see if they can safely help treat the infection.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Eye & ENT Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06451172 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of a novel antisense oligonucleotide (ASO) eye drop treatment for severe antibiotic-resistant bacterial keratitis in adults aged 18 to 70. Approximately 20 participants will be enrolled, and the treatment aims to deliver ASOs specifically to bacteria using a Trojan strategy that targets bacterial-specific transporters. Participants will be monitored over a 90-day follow-up period to assess treatment outcomes and safety.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with severe antibiotic-resistant bacterial keratitis who have not responded to existing antibiotic treatments.
Not a fit: Patients with active eye infections or those with severe dry eye disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new option for patients suffering from severe infections that are resistant to conventional antibiotics.
How similar studies have performed: While the approach of using antisense oligonucleotides is innovative, similar studies targeting antibiotic-resistant infections have shown promise, but this specific application is novel.
Eligibility criteria
Show full inclusion / exclusion 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, 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 (such as severe mental, neurological, cardiovascular, respiratory and other systemic diseases and malignant neoplasms). * Not effective contraception. * In uncontrolled hypertension, systolic is no less than 160 mmhg, diastolic is no less than 100 mmhg. * In uncontrolled diabetes, fasting glucose is no less than 10.0umol/L. * Renal insufficiency, serum creatinine is more than 133umol/L. * Arrhythmia, myocardial ischemia, myocardial infarction (diagnosed by electrocardiogram). * Liver dysfunction, al ANINE aminotransferase and aspartate aminotransferase levels are higher than 80 IU/L. * Platelet level is below 100,000 /uL or above 450,000 /uL. * Hemoglobin level is below 10.0g/dL (male) or 9.0g/dL (female). * No anticoagulant was used, prothrombin time is higher than 16s, and thrombin time of activated part is higher than 50s. * HIV infection (HIV-positive). * Subjects lack compliance with the study or the ability to sign informed consent. * There are currently signs of systemic infection, including fever and ongoing antibiotic treatment (in this study, systemic infection was defined as deviation from normal values of white blood cells, lymphocytes, and neutrophils on routine blood tests). * Administration of Glucocorticoids and other systemic immunosuppressive drugs. * The investigator judges other conditions unsuitable for the trial
Where this trial is running
Shanghai, Shanghai Municipality
- Eye & ENT Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Jiaxu Hong, M.D., Ph.D
- Email: chengmingruicmr@163.com
- Phone: +86-021-64377134
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.