Trial Outcomes & Findings for Study of AzaSite Versus Vigamox in the Tears of Healthy Volunteers (NCT NCT00575367)
NCT ID: NCT00575367
Last Updated: 2011-09-22
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
37 participants
Primary outcome timeframe
15 minutes, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours
Results posted on
2011-09-22
Participant Flow
Participant milestones
| Measure |
AzaSite
|
Vigamox
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
18
|
|
Overall Study
COMPLETED
|
19
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of AzaSite Versus Vigamox in the Tears of Healthy Volunteers
Baseline characteristics by cohort
| Measure |
AzaSite
n=18 Participants
|
Vigamox
n=17 Participants
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
33.9 years
STANDARD_DEVIATION 12.59 • n=5 Participants
|
38.1 years
STANDARD_DEVIATION 13.29 • n=7 Participants
|
36.0 years
STANDARD_DEVIATION 12.92 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 15 minutes, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hoursPopulation: Per Protocol Population
Outcome measures
| Measure |
AzaSite
n=18 Participants
|
Vigamox
n=17 Participants
|
|---|---|---|
|
Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration.
4 Hours
|
1.558 µg/mL
Standard Deviation 2.6151
|
0.603 µg/mL
Standard Deviation 1.0074
|
|
Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration.
15 Minutes
|
16.485 µg/mL
Standard Deviation 22.9971
|
8.199 µg/mL
Standard Deviation 15.9873
|
|
Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration.
1 Hour
|
4.007 µg/mL
Standard Deviation 4.3680
|
2.221 µg/mL
Standard Deviation 4.1506
|
|
Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration.
2 Hours
|
1.966 µg/mL
Standard Deviation 3.6632
|
2.985 µg/mL
Standard Deviation 5.6350
|
|
Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration.
8 Hours
|
2.590 µg/mL
Standard Deviation 4.8111
|
1.364 µg/mL
Standard Deviation 2.7629
|
|
Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration.
24 Hours
|
0.195 µg/mL
Standard Deviation 0.2558
|
0.021 µg/mL
Standard Deviation 0.0449
|
Adverse Events
AzaSite
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vigamox
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI cannot publish or discuss trial results until written communication is received from Inspire Pharmaceuticals, Inc.
- Publication restrictions are in place
Restriction type: OTHER