Cataracts
Conditions
Brief summary
The purpose of this study is to compare drug concentrations in aqueous humor following ocular instillation of Besivance and VIGAMOX in subjects undergoing cataract surgery.
Detailed description
The objective of this study is to compare drug concentrations in aqueous humor following ocular instillation of Besivance or VIGAMOX in subjects undergoing cataract surgery. The hypothesis of the study is that the aggregate aqueous absorption of Besivance over a six hour period is greater than VIGAMOX because of unique properties of Besivance which promote increased contact time of this antibiotic with the ocular surface. Subjects with scheduled cataract surgery will be screened during their pre-operative visit. Eligible subjects will be randomized to treatment with Besivance or VIGAMOX. Subjects will self-administer 1 drop of study drug into the operative eye 4 times a day for 3 days prior to surgery.Subjects will have one final drop of study medication on the day of surgery.Immediately prior to beginning the cataract surgery, a sample of aqueous humor will be collected by paracentesis.Concentration of Besivance and VIGAMOX in the aqueous humor will be determined by an independent laboratory using standardized high pressure liquid chromatography and mass spectrometry assays. Pharmacokinetic parameters determined from the aqueous humor concentration-time data will minimally include the area under the curve and the maximum concentration.
Interventions
DRUGMoxifloxacin
One drop 4 times daily for 3 days and one drop the day of sample collection
DRUGbesifloxacin
One drop 4 times daily for 3 days and one drop on day of sample collection
Sponsors
Frank A. Bucci, Jr., M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Man or woman 18 years of age or older. * Physically capable of instilling eye drop or have an appropriate person available to assist in administration of eye drops 4 times a day. * Scheduled for phacoemulsification with intraocular lens (IOL) implantation for the treatment of cataract. * Meet the American Society of Anesthesiology (ASA) physical status I, II, or III and be medically cleared for surgery. * Willing to adhere to the prohibitions and restrictions specified in this protocol. * Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Exclusion criteria
* Known allergy or contraindication to the test article(s) or their components. * Presence of any abnormality or significant illness in the eye that in the investigator's opinion could affect the subject's health or the study parameters. * Presence of an active ocular infection (bacterial, viral or fungal), or positive history of ocular herpetic infection. * History of any significant illness that could be expected to interfere with the study parameters. Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study. * Use of disallowed therapies (systemic or topical): * Fluoroquinolone anti-infective agents (systemic or topical) within 1 week of Visit 1 or anytime after Visit 1 for the duration of the study. * Use of contact lenses for one week prior to the study and for the duration of the study. * Received an experimental drug or used an experimental medical device within 10 days before the planned start of treatment. * Breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics in Aqueous Humor Samples. | Measured after 3 days of drug instillation | Concentration of Besivance and VIGAMOX in the aqueous humor will be determined by an independent laboratory using standardized high-pressure liquid chromatography and mass spectrometry assays. Pharmacokinetic parameters determined from the aqueous humor concentration will minimally include the area under the curve and the maximum concentration. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VIGAMOX Subjects undergoing cataract surgery, randomized to the VIGAMOX group | 60 |
| Besivance Subjects scheduled for cataract surgery, randomized to the Besivance group | 60 |
| Total | 120 |
Baseline characteristics
| Characteristic | VIGAMOX | Besivance | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 51 Participants | 48 Participants | 99 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 12 Participants | 21 Participants |
| Sex: Female, Male Female | 35 Participants | 28 Participants | 63 Participants |
| Sex: Female, Male Male | 25 Participants | 32 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
Pharmacokinetics in Aqueous Humor Samples.
Concentration of Besivance and VIGAMOX in the aqueous humor will be determined by an independent laboratory using standardized high-pressure liquid chromatography and mass spectrometry assays. Pharmacokinetic parameters determined from the aqueous humor concentration will minimally include the area under the curve and the maximum concentration.
Time frame: Measured after 3 days of drug instillation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VIGAMOX | Pharmacokinetics in Aqueous Humor Samples. | 443.07 ng/ml | Standard Deviation 232.285 |
| Besivance | Pharmacokinetics in Aqueous Humor Samples. | 56.4525 ng/ml | Standard Deviation 39.6325 |