Trial Outcomes & Findings for Antibiotic Resistance In Eye Surgeries (NCT NCT04750655)

NCT ID: NCT04750655

Last Updated: 2025-03-28

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 108 participants
• Primary outcome timeframe: 1 Week
• Results posted on: 2025-03-28

Participant Flow

Participant milestones

Measure	Intraoperative Antibiotics (Abx) Only; no Postoperative Topical Antibiotics intraoperative/ intracameral antibiotic (moxifloxacin) only; no postoperative topical antibiotic drops 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.	Intraoperative Antibiotics (Abx); Postoperative Topical Antibiotics Four Times a Day for 1 Week intraoperative/ intracameral antibiotic (moxifloxacin); postoperative topical antibiotic drops four times a day for 1 week 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.	Intraoperative Antibiotics (Abx); Postoperative Topical Antibiotics Once a Day for 1 Week intraoperative/ intracameral antibiotic (moxifloxacin); postoperative topical antibiotic drops once a day for 1 week 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.
Overall Study STARTED	36	36	36
Overall Study COMPLETED	32	32	34
Overall Study NOT COMPLETED	4	4	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Antibiotic Resistance In Eye Surgeries

Baseline characteristics by cohort

Measure	Intraoperative Antibiotics (Abx) Only; no Postoperative Topical Antibiotics n=36 Participants intraoperative/ intracameral antibiotic (moxifloxacin) only; no postoperative topical antibiotic drops 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.	Intraoperative Antibiotics (Abx); Postoperative Topical Antibiotics Once a Day for 1 Week n=36 Participants intraoperative/ intracameral antibiotic (moxifloxacin); postoperative topical antibiotic drops once a day for 1 week 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.	Intraoperative Antibiotics (Abx); Postoperative Topical Antibiotics Four Times a Day for 1 Week n=36 Participants intraoperative/ intracameral antibiotic (moxifloxacin); postoperative topical antibiotic drops four times a day for 1 week 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.	Total n=108 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=5 Participants	31 Participants n=7 Participants	30 Participants n=5 Participants	95 Participants n=4 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	13 Participants n=4 Participants
Age, Continuous	69 years n=5 Participants	69 years n=7 Participants	69 years n=5 Participants	69 years n=4 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	18 Participants n=7 Participants	15 Participants n=5 Participants	49 Participants n=4 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	18 Participants n=7 Participants	21 Participants n=5 Participants	59 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	13 Participants n=7 Participants	18 Participants n=5 Participants	37 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	17 Participants n=7 Participants	12 Participants n=5 Participants	49 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	17 Participants n=4 Participants
Region of Enrollment United States	36 Participants n=5 Participants	36 Participants n=7 Participants	36 Participants n=5 Participants	108 Participants n=4 Participants

PRIMARY outcome

Timeframe: 1 Week

Population: Enrolled patients who presented to their 1-week follow-up. 9 patients did not present to the 1 week follow-up visit.

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.

Outcome measures

Measure	Intraoperative Antibiotics (Abx) Only; no Postoperative Topical Antibiotics n=32 Participants intraoperative/ intracameral antibiotic (moxifloxacin) only; no postoperative topical antibiotic drops 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.	Intraoperative Antibiotics (Abx); Postoperative Topical Antibiotics Four Times a Day for 1 Week n=35 Participants intraoperative/ intracameral antibiotic (moxifloxacin); postoperative topical antibiotic drops four times a day for 1 week 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.	Intraoperative Antibiotics (Abx); Postoperative Topical Antibiotics Once a Day for 1 Week n=32 Participants intraoperative/ intracameral antibiotic (moxifloxacin); postoperative topical antibiotic drops once a day for 1 week 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.
Antimicrobial Resistance (AMR) of Conjunctiva at 1 Week	0 reads per million reads Standard Deviation 0	0 reads per million reads Standard Deviation 0	0 reads per million reads Standard Deviation 0

SECONDARY outcome

Timeframe: 1 week

Population: Enrolled patients who presented to their 1-week follow-up. 9 patients did not present to the 1 week follow-up visit.

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.

Outcome measures

Measure	Intraoperative Antibiotics (Abx) Only; no Postoperative Topical Antibiotics n=32 Participants intraoperative/ intracameral antibiotic (moxifloxacin) only; no postoperative topical antibiotic drops 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.	Intraoperative Antibiotics (Abx); Postoperative Topical Antibiotics Four Times a Day for 1 Week n=35 Participants intraoperative/ intracameral antibiotic (moxifloxacin); postoperative topical antibiotic drops four times a day for 1 week 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.	Intraoperative Antibiotics (Abx); Postoperative Topical Antibiotics Once a Day for 1 Week n=32 Participants intraoperative/ intracameral antibiotic (moxifloxacin); postoperative topical antibiotic drops once a day for 1 week 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.
Antimicrobial Resistance (AMR) of Nasopharynx at 1 Week	0 reads per million reads Standard Deviation 0	0 reads per million reads Standard Deviation 0	0 reads per million reads Standard Deviation 0

SECONDARY outcome

Timeframe: 1 week

Population: Enrolled patients who presented to their 1-week follow-up. 9 patients did not present to the 1 week follow-up visit.

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.

Outcome measures

Measure	Intraoperative Antibiotics (Abx) Only; no Postoperative Topical Antibiotics n=32 Participants intraoperative/ intracameral antibiotic (moxifloxacin) only; no postoperative topical antibiotic drops 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.	Intraoperative Antibiotics (Abx); Postoperative Topical Antibiotics Four Times a Day for 1 Week n=35 Participants intraoperative/ intracameral antibiotic (moxifloxacin); postoperative topical antibiotic drops four times a day for 1 week 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.	Intraoperative Antibiotics (Abx); Postoperative Topical Antibiotics Once a Day for 1 Week n=32 Participants intraoperative/ intracameral antibiotic (moxifloxacin); postoperative topical antibiotic drops once a day for 1 week 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.
Shannon's Index	14 index Standard Deviation 5	14 index Standard Deviation 5	17 index Standard Deviation 6

SECONDARY outcome

Timeframe: 1 week

Population: Enrolled patients who presented to their 1-week follow-up. 9 patients did not present to the 1 week follow-up visit.

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.

Outcome measures

Measure	Intraoperative Antibiotics (Abx) Only; no Postoperative Topical Antibiotics n=32 Participants intraoperative/ intracameral antibiotic (moxifloxacin) only; no postoperative topical antibiotic drops 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.	Intraoperative Antibiotics (Abx); Postoperative Topical Antibiotics Four Times a Day for 1 Week n=35 Participants intraoperative/ intracameral antibiotic (moxifloxacin); postoperative topical antibiotic drops four times a day for 1 week 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.	Intraoperative Antibiotics (Abx); Postoperative Topical Antibiotics Once a Day for 1 Week n=32 Participants intraoperative/ intracameral antibiotic (moxifloxacin); postoperative topical antibiotic drops once a day for 1 week 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.
Simpson's Index	7 index Standard Deviation 3	8 index Standard Deviation 4	9 index Standard Deviation 4

SECONDARY outcome

Timeframe: 1 week

Population: Enrolled patients who presented to their 1-week follow-up. 9 patients did not present to the 1 week follow-up visit.

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.

Outcome measures

Measure	Intraoperative Antibiotics (Abx) Only; no Postoperative Topical Antibiotics n=32 Participants intraoperative/ intracameral antibiotic (moxifloxacin) only; no postoperative topical antibiotic drops 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.	Intraoperative Antibiotics (Abx); Postoperative Topical Antibiotics Four Times a Day for 1 Week n=35 Participants intraoperative/ intracameral antibiotic (moxifloxacin); postoperative topical antibiotic drops four times a day for 1 week 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.	Intraoperative Antibiotics (Abx); Postoperative Topical Antibiotics Once a Day for 1 Week n=32 Participants intraoperative/ intracameral antibiotic (moxifloxacin); postoperative topical antibiotic drops once a day for 1 week 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.
Simpson's Index	6 index Standard Deviation 5	8 index Standard Deviation 7	5 index Standard Deviation 4

Adverse Events

Intraoperative Antibiotics (Abx) Only; no Postoperative Topical Antibiotics

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intraoperative Antibiotics (Abx); Postoperative Topical Antibiotics Four Times a Day for 1 Week

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intraoperative Antibiotics (Abx); Postoperative Topical Antibiotics Once a Day for 1 Week

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ying Han

University of California, San Francisco

Phone: (415) 353-2020

Email: ying.han@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place