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New treatment option for Bacterial Keratitis
Official title Novel Antisense Oligonucleotide Eye Drops for Treating Antibiotic-Resistant Bacterial Keratitis
ClinicalTrials.gov ID: NCT06451172
What this study is testing
What is ASO?
ASO is an investigational medicine, being studied as a potential treatment for bacterial keratitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The results of antimicrobial susceptibility testing in patients with bacterial keratitis showed multidrug-resistant bacterial infections, and the...
- 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.
You likely can't join if
- 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...
- Ocular surface malignant tumor.
See the full eligibility 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.
- people or their legal guardians voluntarily participate in this study, sign informed consent, good compliance and cooperation with follow-up visits.
- 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).
- people 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...
- Administration of Glucocorticoids and other systemic immunosuppressive drugs.
- The investigator judges other conditions unsuitable for the trial
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.