Keratitis, UlcerativeEarly Phase 1NCT05268718
Au-Ag-Cu2O NG With PTT Anti Drug-resistant Microbial Keratitis
A Early Phase 1 study testing Hollow gold and silver alloy cuprous oxide shell nano-shell hydrogel, Voriconazole eye drops and Normal saline in people with Keratitis, Ulcerative and Antibiotic Resistance, Microbial, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This clinical study was conducted to evaluate the efficacy and safety of gold-silver cuprous oxide composite nanogels combined with photothermal therapy system in the treatment of severe drug-resistant bacterial keratitis ineffective by traditional antibiotic treatment in human eyes, and to provide translational… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Keratitis, Ulcerative, Antibiotic Resistance, Microbial, Photothermal Therapy
- What is being tested?
- Hollow gold and silver alloy cuprous oxide shell nano-shell hydrogel, Voriconazole eye drops and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2021to 1 Jul 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The monocular cases of severe infectious keratitis admitted to our center were diagnosed as fungal keratitis according to their medical history, physical signs and surface secretions smear examination of corneal ulcer lesions (severe was defined as subjects with visual acuity < 0.15, deep stromal infiltration or involvement diameter >2mm, with extensive infiltration around or with extensive suppuration)
- After more than 2 weeks of active treatment with antibiotics, there was no effect
- The researchers communicated with the subjects in detail, and the subjects cooperated well and they voluntarily participated and signed informed consent
Who cannot join
- Allergic to the drug in this test.
- Pregnant and lactating women.
- The medical history suggests serious heart, lung, liver, kidney dysfunction.
- Patients with other factors that would affect the results of this result.
- No signed informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Yue Qiao, PhD, +8619818504850, qiaosensei@zju.edu.cn
About this study
Official title: Gold-silver-cuprous Oxide (Au-Ag-Cu2O) Composite Nanogel Combined With Photothermal Therapy in the Treatment of Severe Drug-resistant Microbial Keratitis
This clinical study was conducted to evaluate the efficacy and safety of gold-silver cuprous oxide composite nanogels combined with photothermal therapy system in the treatment of severe drug-resistant bacterial keratitis ineffective by traditional antibiotic treatment in human eyes, and to provide translational applications. Based on the clinical evidence, a more effective and safe innovative treatment plan for corneal diseases has been developed.
- Being tested
- Hollow gold and silver alloy cuprous oxide shell nano-shell hydrogel, Voriconazole eye drops, Normal saline
- Keywords
- Photothermal Therapy, Keratitis, Ulcerative, Antibiotic Resistance, Microbial
- Medical subject headings
- Corneal Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hollow gold and silver alloy cuprous oxide shell nano-shell hydrogelDrug
Also called Au-Ag-Cu2O nano-gel
Hollow gold and silver alloy cuprous oxide shell nano-shell hydrogel was excited by NIR laser to release functional silver ions, copper ions and ROS.
Voriconazole eye dropsDrug
Also called VRC
Voriconazole eye drops (1%) were administrated to infectious eye very frequently (once half an hour)
Normal salineOther
Also called NS
To be placebo, normal saline were administrated to infectious eye
| Study group | Role | What they receive |
|---|---|---|
| Nanogel photothermal therapy | Experimental | After the subjects were enrolled in the study, the eyes were coated with Au-Ag-Cu2O nano-gel once (the concentration was 26.4μg/mL, the dosage was suitable to cover the ulcer surface evenly, and the dosage was recorded). Combined with mdl-n-808-10w near-infrared laser (China changchun new industry photoelectric technology) combined with photothermal therapy (laser wavelength 808 nm, power 1.5W/cm2, temperature controlled at 40℃, lasting 10min) Receives: Drug: Hollow gold and silver alloy cuprous oxide shell nano-shell hydrogel |
| Voriconazole eye drops | Active comparator | Voliconazole eye drops (once in half an hour) were also used in the control group. Receives: Drug: Voriconazole eye drops |
| Normal saline | Placebo comparator | Normal saline eye drops (once in half an hour) were also used in the control group. Receives: Other: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior segment photography
corneal edema, keratohelcosis, hppopyon
Measured: 1 month
confocal microscopy
fungal hyphae in corneal surface
Measured: 1 month
Secondary outcomes (2)
eye pressure
Measurement of contact tonometry with iCare TA01i tonometer after treatment (1 day, 1 week, 1 month)
Measured: 1 month
visual acuity
Measurement of distance visual acuity with subjective refraction after treatment (1 week, 1 month)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start1 Aug 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratitis, UlcerativeStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ke Yao, MD, Study director, Second Affiliated Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268718
- Sponsor's protocol ID
- 2021-0635
- Status last verified
- Aug 2021
- First submitted
- 9 Feb 2022
- Last updated
- 7 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gold-silver-cuprous Oxide (Au-Ag-Cu2O) Composite Nanogel Combined With Photothermal Therapy in the Treatment of Severe Drug-resistant Microbial Keratitis
- ClinicalTrials.gov ID
- NCT05268718
- Acronym / sponsor ID
- 2021-0635
- Keywords
- Photothermal Therapy, Keratitis, Ulcerative, Antibiotic Resistance, Microbial
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 7 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study was conducted to evaluate the efficacy and safety of gold-silver cuprous oxide composite nanogels combined with photothermal therapy system in the treatment of severe drug-resistant bacterial keratitis ineffective by traditional antibiotic treatment in human eyes, and to provide translational applications. Based on the clinical evidence, a more effective and safe innovative treatment plan for corneal diseases has been developed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nanogel photothermal therapy | Experimental | Drug: Hollow gold and silver alloy cuprous oxide shell nano-shell hydrogelAfter the subjects were enrolled in the study, the eyes were coated with Au-Ag-Cu2O nano-gel once (the concentration was 26.4μg/mL, the dosage was suitable to cover the ulcer surface evenly, and the dosage was recorded). Combined with mdl-n-808-10w near-infrared laser (China changchun new industry photoelectric technology) combined with photothermal therapy (laser wavelength 808 nm, power 1.5W/cm2, temperature controlled at 40℃, lasting 10min) |
| Voriconazole eye drops | Active comparator | Drug: Voriconazole eye dropsVoliconazole eye drops (once in half an hour) were also used in the control group. |
| Normal saline | Placebo comparator | Other: Normal salineNormal saline eye drops (once in half an hour) were also used in the control group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The monocular cases of severe infectious keratitis admitted to our center were diagnosed as fungal keratitis according to their medical history, physical signs and surface secretions smear examination of corneal ulcer lesions (severe was defined as subjects with visual acuity < 0.15, deep stromal infiltration or involvement diameter >2mm, with extensive infiltration around or with extensive suppuration)
- After more than 2 weeks of active treatment with antibiotics, there was no effect
- The researchers communicated with the subjects in detail, and the subjects cooperated well and they voluntarily participated and signed informed consent
Key exclusion criteria (5 listed)
- Allergic to the drug in this test.
- Pregnant and lactating women.
- The medical history suggests serious heart, lung, liver, kidney dysfunction.
- Patients with other factors that would affect the results of this result.
- No signed informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hollow gold and silver alloy cuprous oxide shell nano-shell hydrogelAlso: Au-Ag-Cu2O nano-gelHollow gold and silver alloy cuprous oxide shell nano-shell hydrogel was excited by NIR laser to release functional silver ions, copper ions and ROS. | Drug | Nanogel photothermal therapy |
| Voriconazole eye dropsAlso: VRCVoriconazole eye drops (1%) were administrated to infectious eye very frequently (once half an hour) | Drug | Voriconazole eye drops |
| Normal salineAlso: NSTo be placebo, normal saline were administrated to infectious eye | Other | Normal saline |
Primary outcome
Anterior segment photography
Time frame: 1 month
corneal edema, keratohelcosis, hppopyon
confocal microscopy
Time frame: 1 month
fungal hyphae in corneal surface
2 secondary outcomes
eye pressure
Time frame: 1 month
visual acuity
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ke Yao, MD study director
Second Affiliated Hospital of Zhejiang University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Hollow gold and silver alloy cuprous oxide shell nano-shell hydrogel, Voriconazole eye drops and Normal saline in people with Keratitis, Ulcerative and Antibiotic Resistance, Microbial, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yue Qiao, PhD (+8619818504850, qiaosensei@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anterior segment photography (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2022.