Cataract
Conditions
Keywords
Aqueous Humor, Moxifloxacin, Vigadexa
Brief summary
The purpose of this study was to determine the moxifloxacin aqueous penetration when dosing with a combination drug Vigadexa preoperatively in cataract patients.
Interventions
DRUGMoxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Requires cataract surgery; * Acceptable health status (medical history, physical, laboratory and ophthalmologic exams); * Able to follow instructions and willing to attend all study visits; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Any known or suspected allergies/hypersensitivity to any of the investigational test product components; * History of invasive intraocular surgery in the eye to be operated, within 4 months before enrollment; * Use of medications, as specified in protocol; * Severe dry eye syndrome; * Use of contact lenses two days before surgery until the last visit; * External eye disease, infection or inflammation of the eyes or eyelids; * Excessive bleeding tendency; * No vision in the eye not included in the study; * Pregnant or breastfeeding; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Aqueous Humor Concentration of Moxifloxacin | Day 3 (operative day) | A 0.150 milliliter sample of the aqueous humor was obtained during cataract surgery. The concentration of moxifloxacin was measured by a validated procedure using high performance liquid-spectrometry. |
Participant flow
Recruitment details
Subjects were recruited from one study center in Brazil.
Pre-assignment details
This reporting group includes all enrolled subjects.
Participants by arm
| Arm | Count |
|---|---|
| VIGADEXA Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution, 1 drop instilled in the study eye 2 days before surgery, followed by 1 drop instilled 4 times a day the day before surgery. On the day of surgery, 1 drop was instilled 60 minutes prior to the procedure. | 35 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Protocol deviation | 3 |
Baseline characteristics
| Characteristic | VIGADEXA |
|---|---|
| Age Continuous | 71.2 years STANDARD_DEVIATION 10.4 |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 36 |
| serious Total, serious adverse events | 0 / 36 |
Outcome results
Primary
Mean Aqueous Humor Concentration of Moxifloxacin
A 0.150 milliliter sample of the aqueous humor was obtained during cataract surgery. The concentration of moxifloxacin was measured by a validated procedure using high performance liquid-spectrometry.
Time frame: Day 3 (operative day)
Population: Per protocol: All subjects who met inclusion/exclusion criteria, received all doses of the test product, and underwent cataract surgery with aqueous humor sampling.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| VIGADEXA | Mean Aqueous Humor Concentration of Moxifloxacin | 1110.6 nanograms per milliliter |