Cataract Extraction
Conditions
Keywords
Bioavailability
Brief summary
This study is being conducted to assess the concentration of besifloxacin, moxifloxacin, or gatifloxacin in aqueous humor samples collected following topical instillation of the associated formulation in subjects undergoing cataract surgery.
Interventions
DRUGBesifloxacin hydrochloride
Instill besifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.
Instill moxifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.
DRUGgatifloxacin
Instill gatifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects who are a candidate for a routine, uncomplicated, primary cataract extraction. * Subjects who, in the Investigator's opinion, have potential for postoperative best corrected Snellen visual acuity of at least 20/200 in the study eye.
Exclusion criteria
* Subjects who have a known sensitivity, contraindication, or allergy to the study medication(s) or their components. * Subjects who had any corneal refractive surgery in the study eye. * Subjects who have a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result of the study. * Subjects who had ocular surgery in the study eye, including laser procedures, within the past 6 months. * Subjects who have taken any topical ocular medication in the study eye, other than those required by the protocol and permitted for surgery, during the 24 hours prior to the study medication being instilled. * Subjects who use any antibiotics (e.g., systemic or topical) within the 7 days prior to the surgery date. * Subjects who are monocular.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Aqueous Humor Drug Concentration. | Visit 2, 1-14 days following screening visit | An aqueous humor specimen was collected from the study eye for determination of drug concentration 60 min after study drug instillation. |
Countries
United States
Participant flow
Recruitment details
This study was conducted a 6 sites in the US. This was a single dose study with first patient enrollment on 2/2/2009 and last patient visit was 7/9/2009.
Pre-assignment details
105 subjects were screened at Visit 1 and qualified subjects returned on the day of surgery (Visit 2).
Participants by arm
| Arm | Count |
|---|---|
| Besifloxacin Besifloxacin ophthalmic suspension | 34 |
| Moxifloxacin Vigamox (moxifloxacin ophthalmic solution, 0.5%) | 35 |
| Gatifloxacin Zymar (gatifloxacin ophthalmic solution, 0.3%) | 36 |
| Total | 105 |
Baseline characteristics
| Characteristic | Total | Besifloxacin | Moxifloxacin | Gatifloxacin |
|---|---|---|---|---|
| Age, Customized 60-69 years | 32 participants | 15 participants | 7 participants | 10 participants |
| Age, Customized <60 years | 13 participants | 4 participants 8.1 | 4 participants 9.9 | 5 participants 9.6 |
| Age, Customized 70-79 years | 44 participants | 11 participants | 19 participants | 14 participants |
| Age, Customized >/= 80 | 16 participants | 4 participants | 5 participants | 7 participants |
| Race/Ethnicity, Customized Caucasian | 98 participants | 31 participants | 33 participants | 34 participants |
| Race/Ethnicity, Customized Non-Caucasian | 7 participants | 3 participants | 2 participants | 2 participants |
| Sex: Female, Male Female | 59 Participants | 18 Participants | 21 Participants | 20 Participants |
| Sex: Female, Male Male | 46 Participants | 16 Participants | 14 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 34 | 0 / 35 | 0 / 36 |
| serious Total, serious adverse events | 0 / 34 | 0 / 35 | 0 / 36 |
Outcome results
Primary
The Aqueous Humor Drug Concentration.
An aqueous humor specimen was collected from the study eye for determination of drug concentration 60 min after study drug instillation.
Time frame: Visit 2, 1-14 days following screening visit
Population: Statistical Analysis of AH Drug Concentration. Modified intent to treat population (mITT). Subjects with non-missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Besifloxacin | The Aqueous Humor Drug Concentration. | 0.1349 µg/mL | Standard Deviation 0.582 |
| Moxifloxacin | The Aqueous Humor Drug Concentration. | 0.6681 µg/mL | Standard Deviation 0.498 |
| Gatifloxacin | The Aqueous Humor Drug Concentration. | 0.1251 µg/mL | Standard Deviation 0.07624 |