Trial Outcomes & Findings for Study of Ocular Penetration of Topically Administered Fluoroquinolones (NCT NCT00924729)

Results Overview

Patients were randomly assigned to receive one drop of either moxifloxacin or besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30 minutes prior to the time of the cataract incision. The aqueous humor was corrected through the paracentesis site. The specimen was transferred immediately to a polypropylene tube and stored upright at ≤ 20° C. Moxifloxacin and besifloxacin concentrations in the aqueous humor were determined using a validated high performance liquid chromatography (HPLC)-tandem mass spectrometry method.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

50 participants

Primary outcome timeframe

approximately 3 to 4 months

Results posted on

2017-10-24

Participant Flow

Participant milestones

Participant milestones
Measure	Moxifloxacin 0.5% Ophthalmic Solution The patients in this group received one drop of moxifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.	Besifloxacin 0.6% Ophthalmic Suspension The patients in this group received one drop of besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
Overall Study STARTED	25	25
Overall Study COMPLETED	23	25
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Moxifloxacin 0.5% Ophthalmic Solution The patients in this group received one drop of moxifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.	Besifloxacin 0.6% Ophthalmic Suspension The patients in this group received one drop of besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
Overall Study insufficient volume for analysis	1	0
Overall Study Protocol Violation	1	0

Baseline Characteristics

Study of Ocular Penetration of Topically Administered Fluoroquinolones

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Moxifloxacin 0.5% Ophthalmic Solution n=25 Participants The patients in this group received one drop of moxifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.	Besifloxacin 0.6% Ophthalmic Suspension n=25 Participants The patients in this group received one drop of besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.	Total n=50 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
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	22 Participants n=5 Participants	18 Participants n=7 Participants	40 Participants n=5 Participants
Age, Continuous	74.0 years STANDARD_DEVIATION 8.90 • n=5 Participants	68.0 years STANDARD_DEVIATION 14.0 • n=7 Participants	71.0 years STANDARD_DEVIATION 12.0 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: approximately 3 to 4 months

Patients were randomly assigned to receive one drop of either moxifloxacin or besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30 minutes prior to the time of the cataract incision. The aqueous humor was corrected through the paracentesis site. The specimen was transferred immediately to a polypropylene tube and stored upright at ≤ 20° C. Moxifloxacin and besifloxacin concentrations in the aqueous humor were determined using a validated high performance liquid chromatography (HPLC)-tandem mass spectrometry method.

Outcome measures

Outcome measures
Measure	Moxifloxacin 0.5% Ophthalmic Solution n=23 Participants The patients in this group received one drop of moxifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.	Besifloxacin 0.6% Ophthalmic Suspension n=25 Participants The patients in this group received one drop of besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
Aqueous Humor Concentration of Study Drug	1.6108 µg/ml Standard Deviation 0.6835	0.0312 µg/ml Standard Deviation 0.0131

SECONDARY outcome

Timeframe: Approximately 3-4 months.

Population: The amount of aqueous concentration of antibiotic agent was not enough to perform a secondary analysis

A disk diffusion assay was performed to determine the relative antimicrobial activity of the study drug in the aqueous humor. The reference organism used was a clinical isolate of S. epidermidis that will be grown and adjusted to a 0.5 MacFarland turbidity standard. The standardized suspension was inoculated onto a Mueller-Hinton II agar. A sample of the aqueous humor was applied to 6 mm sterile disks, dried, and then placed onto the inoculated Mueller-Hinton II agar plates. The plates were incubated for 24 hours at 35° C. The zone sizes were then recorded.

Outcome measures

Outcome data not reported

Adverse Events

Moxifloxacin 0.5% Ophthalmic Solution

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Besifloxacin 0.6% Ophthalmic Suspension

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

Walter J. Stark, M.D./Professor of Ophthalmology

Johns Hopkins University

Phone: 410-955-5490

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place