Trial Outcomes & Findings for Pharmacokinetic Evaluation of Moxifloxacin in Vigadexa® in Aqueous Humor Samples Following Preoperative Antibiotic/Steroid Dosing in Cataract Surgery Patients (NCT NCT01859702)
NCT ID: NCT01859702
Last Updated: 2013-08-07
Results Overview
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.
COMPLETED
PHASE4
36 participants
Day 3 (operative day)
2013-08-07
Participant Flow
Subjects were recruited from one study center in Brazil.
This reporting group includes all enrolled subjects.
Participant milestones
| Measure |
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.
|
|---|---|
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Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
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Overall Study
Protocol deviation
|
3
|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
Pharmacokinetic Evaluation of Moxifloxacin in Vigadexa® in Aqueous Humor Samples Following Preoperative Antibiotic/Steroid Dosing in Cataract Surgery Patients
Baseline characteristics by cohort
| Measure |
VIGADEXA
n=35 Participants
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.
|
|---|---|
|
Age Continuous
|
71.2 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
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21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
VIGADEXA
n=31 Participants
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.
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|---|---|
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Mean Aqueous Humor Concentration of Moxifloxacin
|
1110.6 nanograms per milliliter
Interval 857.5 to 1363.7
|
Adverse Events
VIGADEXA
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
VIGADEXA
n=36 participants at risk
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.
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|---|---|
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Cardiac disorders
Hypertensive Crisis
|
5.6%
2/36 • Adverse events were collected for the duration of the study. An adverse event was defined as any untoward medical occurrence, or deterioration of a pre-existing medical condition, that occurred during or after test product administration.
Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
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Additional Information
Abayomi Ogundele, Global Medical Affairs Brand Lead
Alcon Research, Ltd.
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER