Cataracts
Conditions
Brief summary
To compare antibacterial efficacy of Besivance versus VIGAMOX for decreasing bacteria of the conjunctiva and lid margins in cataract patients prior to surgery after both 1 hour and 3 days of treatment.
Interventions
Sponsors
Bucci Laser Vision Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 21 days before the planned start of treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With a Change in Bacterial Colonization of Lid and Conjunctival Cultures After 3 Days | Following 3 days of antibiotic drops topically instilled | Lid and Conjunctival cultures will be taken to measure bacterial colonization. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VIGAMOX Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection | 30 |
| Besivance Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | VIGAMOX | Besivance | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 27 Participants | 23 Participants | 50 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 7 Participants | 10 Participants |
| Sex: Female, Male Female | 18 Participants | 16 Participants | 34 Participants |
| Sex: Female, Male Male | 12 Participants | 14 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 28 |
| serious Total, serious adverse events | 0 / 30 | 0 / 28 |
Outcome results
Primary
Number of Subjects With a Change in Bacterial Colonization of Lid and Conjunctival Cultures After 3 Days
Lid and Conjunctival cultures will be taken to measure bacterial colonization.
Time frame: Following 3 days of antibiotic drops topically instilled
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VIGAMOX | Number of Subjects With a Change in Bacterial Colonization of Lid and Conjunctival Cultures After 3 Days | 18 Participants |
| Besivance | Number of Subjects With a Change in Bacterial Colonization of Lid and Conjunctival Cultures After 3 Days | 28 Participants |