Antibiotic ResistancePhase 4ARIESNCT04750655
Antibiotic Resistance In Eye Surgeries
A Phase 4 study testing Moxifloxacin (Topical) in people with Antibiotic Resistance and Ocular Surface Microbiome, run by University of California, San Francisco at 1 site in United States.
Trial summary
In this study, the investigators seek to determine the effect of antibiotic use post-surgery on antimicrobial resistance. The investigators will be studying adults (aged 18 or older) who will undergo eye surgery at University of California, San Francisco (UCSF). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Antibiotic Resistance, Ocular Surface Microbiome, Gut Resistome
- What is being tested?
- Moxifloxacin (Topical)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 31 Aug 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years of age
- Undergoing cataract surgeries that would benefit from intracameral antibiotics
- Able to provide swabs
- Able to provide consent
- Surgery of the second eye occurs at least 8 weeks after surgery of the first eye
Who cannot join
- Same-day bilateral cataract surgeries
- On immunosuppression medication such as Prednisone, Methotrexate, Cellcept, or anti-TNF inhibitors within past 3 months
- On systemic antibiotic within past 3 months
- On topical antibiotics within past 8 weeks
- Allergies to fluoroquinolone
- Patients needing glaucoma drainage device or trabeculectomy
- Inability to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94158
About this study
Official title: Antibiotic Resistance In Eye Surgeries (ARIES)
In this study, the investigators seek to determine the effect of antibiotic use post-surgery on antimicrobial resistance. The investigators will be studying adults (aged 18 or older) who will undergo eye surgery at University of California, San Francisco (UCSF). We seek to gain a better understanding of how antibiotic use during the perioperative period influences local and systemic antibiotic resistance at the individual level.
Read the detailed description
Antibiotic use has saved millions of lives globally. However, this comes at the cost of selecting for antibiotic-resistant organisms at the individual and the community level. It is estimated that every year, approximately 700,000 deaths are associated with drug resistance globally. This places a significant burden on the public health system and the judicious use of antibiotics is more important than ever before.
The proposed masked, randomized controlled trial evaluates the effects of topical antibiotic use on the selection of antibiotic resistance determinants at the local and systemic levels. The results will provide guidance for antibiotic usage in ophthalmology and may have the potential to inform public health policies.
- Being tested
- Moxifloxacin (Topical)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxifloxacin (Topical)Drug
We are using moxifloxacin as indicated and as intended for use as an antibiotic during surgery. Frequency of postoperative antibiotics dependent on group randomization.
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative antibiotics (Abx) only; no postoperative topical antibiotics | Placebo comparator | intraoperative/ intracameral antibiotic (moxifloxacin) only; no postoperative topical antibiotic drops Receives: Drug: Moxifloxacin (Topical) |
| Intraoperative antibiotics (Abx); Postoperative topical antibiotics four times a day for 1 week | Active comparator | intraoperative/ intracameral antibiotic (moxifloxacin); postoperative topical antibiotic drops four times a day for 1 week Receives: Drug: Moxifloxacin (Topical) |
| Intraoperative antibiotics (Abx); Postoperative topical antibiotics once a day for 1 week | Active comparator | intraoperative/ intracameral antibiotic (moxifloxacin); postoperative topical antibiotic drops once a day for 1 week Receives: Drug: Moxifloxacin (Topical) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antimicrobial Resistance (AMR) of Conjunctiva at 1 Week
Normalized read counts (reads per million reads or rM) for fluoroquinolone resistance determinants from DNA deep sequencing for the conjunctival swabs at 1 week, which represent the abundance of resistance in the sample.
Measured: 1 Week
Secondary outcomes (4)
Antimicrobial Resistance (AMR) of Nasopharynx at 1 Week
Normalized read counts (reads per million reads or rM) for fluoroquinolone resistance determinants from DNA deep sequencing for the nasopharyngeal swabs at 1 week, which represent the abundance of resistance in the sample.
Measured: 1 week
Shannon's Index
Conjunctival samples were evaluated for microbiome heterogeneity at 1 week. Shannon's index (H) represents a measure of bacteria species heterogeneity and is calculated through the following formula, H = -sum(pi*log(b)*pi), where pi is the proportional abundance of species and b is the base of the logarithm. Here, we are using the natural logarithm.
The Shannon's Index ranges from 0 to ln(S), where S is the number of species in the community. We report the exponentiated Shannon's Index, which is expressed as the "effective number of species", which ranges from 1 to S species. An effective number of species of 1 indicates that 1 species dominates the microbiome. The greater the effective number of species, the greater the heterogeneity of species abundance in the microbiome. Low heterogeneity of bacterial species in the microbiome is a proxy for a less healthy system.
Measured: 1 week
Simpson's Index
Conjunctival samples were evaluated for microbiome heterogeneity at 1 week. Simpson's index (D) represents a measure of bacteria species heterogeneity and is calculated through the following formula, D = sum(pi^2), where pi is the proportional abundance of species.
The Simpson's Index ranges from 0 to 1, where 0 represents infinite heterogeneity and 1 represents no heterogeneity. We report the inverse of Simpson's Index, which is expressed as the "effective number of species", which ranges from 1 to S species. An effective number of species of 1 indicates that 1 species dominates the microbiome. The greater the effective number of species, the greater the heterogeneity of species abundance in the microbiome. Low heterogeneity of bacterial species in the microbiome is a proxy for a less healthy system.
Measured: 1 week
Simpson's Index
Nasopharyngeal samples were evaluated for microbiome heterogeneity at 1 week. Simpson's index (D) represents a measure of bacteria species heterogeneity and is calculated through the following formula, D = sum(pi^2), where pi is the proportional abundance of species.
The Simpson's Index ranges from 0 to 1, where 0 represents infinite heterogeneity and 1 represents no heterogeneity. We report the inverse of Simpson's Index, which is expressed as the "effective number of species", which ranges from 1 to S species. An effective number of species of 1 indicates that 1 species dominates the microbiome. The greater the effective number of species, the greater the heterogeneity of species abundance in the microbiome. Low heterogeneity of bacterial species in the microbiome is a proxy for a less healthy system.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start1 Mar 2021
- Primary completion10 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antibiotic ResistanceStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying Han, MD, PhD, Principal investigator, University of California, San FranciscoThuy Doan, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04750655
- Sponsor's protocol ID
- IRB#20-30037
- Acronym
- ARIES
- Status last verified
- Mar 2025
- First submitted
- 5 Feb 2021
- Last updated
- 28 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gaynor BD, Chidambaram JD, Cevallos V, Miao Y, Miller K, Jha HC, Bhatta RC, Chaudhary JS, Osaki Holm S, Whitcher JP, Holbrook KA, Fry AM, Lietman TM. Topical ocular antibiotics induce bacterial resistance at extraocular sites. Br J Ophthalmol. 2005 Sep;89(9):1097-9. doi: 10.1136/bjo.2005.068981.
PubMed 16113356
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Resistance In Eye Surgeries (ARIES)
- ClinicalTrials.gov ID
- NCT04750655
- Acronym / sponsor ID
- ARIES / IRB#20-30037
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 11 Feb 2021 (actual)
- Results
- Posted 28 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the investigators seek to determine the effect of antibiotic use post-surgery on antimicrobial resistance. The investigators will be studying adults (aged 18 or older) who will undergo eye surgery at University of California, San Francisco (UCSF). We seek to gain a better understanding of how antibiotic use during the perioperative period influences local and systemic antibiotic resistance at the individual level.
Detailed description
Antibiotic use has saved millions of lives globally. However, this comes at the cost of selecting for antibiotic-resistant organisms at the individual and the community level. It is estimated that every year, approximately 700,000 deaths are associated with drug resistance globally. This places a significant burden on the public health system and the judicious use of antibiotics is more important than ever before.
The proposed masked, randomized controlled trial evaluates the effects of topical antibiotic use on the selection of antibiotic resistance determinants at the local and systemic levels. The results will provide guidance for antibiotic usage in ophthalmology and may have the potential to inform public health policies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intraoperative antibiotics (Abx) only; no postoperative topical antibiotics | Placebo comparator | Drug: Moxifloxacin (Topical)intraoperative/ intracameral antibiotic (moxifloxacin) only; no postoperative topical antibiotic drops |
| Intraoperative antibiotics (Abx); Postoperative topical antibiotics four times a day for 1 week | Active comparator | Drug: Moxifloxacin (Topical)intraoperative/ intracameral antibiotic (moxifloxacin); postoperative topical antibiotic drops four times a day for 1 week |
| Intraoperative antibiotics (Abx); Postoperative topical antibiotics once a day for 1 week | Active comparator | Drug: Moxifloxacin (Topical)intraoperative/ intracameral antibiotic (moxifloxacin); postoperative topical antibiotic drops once a day for 1 week |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Over 18 years of age
- Undergoing cataract surgeries that would benefit from intracameral antibiotics
- Able to provide swabs
- Able to provide consent
- Surgery of the second eye occurs at least 8 weeks after surgery of the first eye
Key exclusion criteria (7 listed)
- Same-day bilateral cataract surgeries
- On immunosuppression medication such as Prednisone, Methotrexate, Cellcept, or anti-TNF inhibitors within past 3 months
- On systemic antibiotic within past 3 months
- On topical antibiotics within past 8 weeks
- Allergies to fluoroquinolone
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 |
|---|---|---|
| Moxifloxacin (Topical)We are using moxifloxacin as indicated and as intended for use as an antibiotic during surgery. Frequency of postoperative antibiotics dependent on group randomization. | Drug | Intraoperative antibiotics (Abx) only; no postoperative topical antibiotics, Intraoperative antibiotics (Abx); Postoperative topical antibiotics four times a day for 1 week, Intraoperative antibiotics (Abx); Postoperative topical antibiotics once a day for 1 week |
Primary outcome
Antimicrobial Resistance (AMR) of Conjunctiva at 1 Week
Time frame: 1 Week
Normalized read counts (reads per million reads or rM) for fluoroquinolone resistance determinants from DNA deep sequencing for the conjunctival swabs at 1 week, which represent the abundance of resistance in the sample.
4 secondary outcomes
Antimicrobial Resistance (AMR) of Nasopharynx at 1 Week
Time frame: 1 week
Shannon's Index
Time frame: 1 week
Simpson's Index
Time frame: 1 week
Simpson's Index
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16113356Gaynor BD, Chidambaram JD, Cevallos V, Miao Y, Miller K, Jha HC, Bhatta RC, Chaudhary JS, Osaki Holm S, Whitcher JP, Holbrook KA, Fry AM, Lietman TM. Topical ocular antibiotics induce bacterial resistance at extraocular sites. Br J Ophthalmol. 2005 Sep;89(9):1097-9. doi: 10.1136/bjo.2005.068981.
- Individual participant dataSharing planned: No
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Effect of a Probiotic or Postbiotic on Gut Microbiome During Antibiotic Treatment
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Recruiting
Nasopharyngeal Carriage of S. Pneumoniae
Nasopharyngeal Carriage, Children, Only
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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.
Ying Han, MD, PhD principal investigator
University of California, San Francisco
Thuy Doan, MD, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Moxifloxacin (Topical) in people with Antibiotic Resistance and Ocular Surface Microbiome, run by University of California, San Francisco at 1 site in United States.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 28 Mar 2025. 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 United States. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antimicrobial Resistance (AMR) of Conjunctiva at 1 Week (time frame: 1 Week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04750655, which also lists 1 linked publication.
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 28 Mar 2025.