Cataract Extraction
Conditions
Brief summary
This study is being conducted to evaluate the intraocular penetration of Moxifloxacin 0.5% ophthalmic solution (Vigamox) and Besifloxacin 0.6% ophthalmic suspension (Besivance) after pre-operative topical administration in subjects undergoing cataract surgery.
Interventions
Administer moxifloxacin study drug prior to cataract surgery.
DRUGBesifloxacin 0.6% ophthalmic suspension
Administer besifloxacin study drug prior to cataract surgery.
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects who have a visually significant cataract and are planning to have cataract surgery. * Subjects who are willing/able and have signed informed consent approved by the Institutional Review Board.
Exclusion criteria
* Subjects who have a known hypersensitivity, allergy, or contraindication to any fluoroquinolone medication, in any form. * Subjects who signs of ocular infection or active inflammation in the study eye. * Subjects who have corneal pathology, including epithelial defect, corneal scarring, or severe dry eye syndrome. * Subjects who have used any disallowed medication (including antibiotics) during the time period designated as described in the protocol. * Subjects who have any active or chronic/recurrent ocular or systemic disease that is uncontrolled and is likely to increase the risk of infection to the patient or confound the results of the study. * Subjects who are pregnant (or suspect to be pregnant) or nursing/lactating. * Subjects who have participated in any study of an investigational drug or device within 30 days prior to enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aqueous Humor Concentration of Study Drug | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disk Diffusion Assay of Collected Aqueous Humor | Approximately 3-4 months. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| 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. | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | insufficient volume for analysis | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Besifloxacin 0.6% Ophthalmic Suspension | Moxifloxacin 0.5% Ophthalmic Solution | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 22 Participants | 40 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 3 Participants | 10 Participants |
| Age, Continuous | 68.0 years STANDARD_DEVIATION 14 | 74.0 years STANDARD_DEVIATION 8.9 | 71.0 years STANDARD_DEVIATION 12 |
| Region of Enrollment United States | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 10 Participants | 11 Participants | 21 Participants |
| Sex: Female, Male Male | 15 Participants | 14 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Aqueous Humor Concentration of Study Drug
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.
Time frame: approximately 3 to 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Moxifloxacin 0.5% Ophthalmic Solution | Aqueous Humor Concentration of Study Drug | 1.6108 µg/ml | Standard Deviation 0.6835 |
| Besifloxacin 0.6% Ophthalmic Suspension | Aqueous Humor Concentration of Study Drug | 0.0312 µg/ml | Standard Deviation 0.0131 |
p-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
Disk Diffusion Assay of Collected Aqueous Humor
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.
Time frame: Approximately 3-4 months.
Population: The amount of aqueous concentration of antibiotic agent was not enough to perform a secondary analysis