Trial Outcomes & Findings for Tobramycin Tear Concentrations (NCT NCT00695435)
NCT ID: NCT00695435
Last Updated: 2010-03-02
Results Overview
Tear samples were collected to measure tobramycin concentrations at 2, 4, 6, 12, and 18 minutes post-drop instillation in each subject's right eye for each treatment period.
COMPLETED
PHASE1
21 participants
2, 4, 6, 12, and 18 minutes
2010-03-02
Participant Flow
Randomized, single center (Alcon Eye Clinic),
Treatment randomization schedules were generated and maintained by the Alcon SAS Programming group. Only when the data were verified and validated and the database locked were the appropriate personnel unmasked.
Participant milestones
| Measure |
TOBRADEX, Then Tob 0.3%/Dex 0.05%, Then TOBREX
Patients received TOBRADEX first, then Tob 0.3%/Dex 0.05%, then TOBREX
|
Tob 0.3%/Dex 0.05%, Then TOBREX, Then TOBRADEX
Patients received Tob 0.3%/Dex 0.05% first, then TOBREX, then TOBRADEX
|
TOBREX, Then TOBRADEX, Then Tob 0.3%/Dex 0.05%
Patients received TOBREX first, then TOBRADEX, then Tob 0.3%/Dex 0.05%
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
7
|
|
Overall Study
COMPLETED
|
7
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tobramycin Tear Concentrations
Baseline characteristics by cohort
| Measure |
Overall Study
n=21 Participants
Overall Study
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2, 4, 6, 12, and 18 minutesTear samples were collected to measure tobramycin concentrations at 2, 4, 6, 12, and 18 minutes post-drop instillation in each subject's right eye for each treatment period.
Outcome measures
| Measure |
Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension
n=21 Participants
Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension
|
TOBREX® Ophthalmic Solution
n=21 Participants
TOBREX® Ophthalmic Solution
|
TOBRADEX® Ophthalmic Suspension
n=21 Participants
TOBRADEX® Ophthalmic Suspension
|
|---|---|---|---|
|
Tobramycin Tear Concentration Cmax (Maximum Concentration)
|
853 µg/mL
Standard Deviation 618
|
527 µg/mL
Standard Deviation 428
|
542 µg/mL
Standard Deviation 425
|
SECONDARY outcome
Timeframe: 2 to 18 minutes post administrationTrapezoidal AUC was calculated from 2 to 18 minutes.
Outcome measures
| Measure |
Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension
n=21 Participants
Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension
|
TOBREX® Ophthalmic Solution
n=21 Participants
TOBREX® Ophthalmic Solution
|
TOBRADEX® Ophthalmic Suspension
n=21 Participants
TOBRADEX® Ophthalmic Suspension
|
|---|---|---|---|
|
Tobramycin Tear Concentration Area Under the Curve (AUC)
|
6124 min*ug/mL
Standard Deviation 4776
|
2119 min*ug/mL
Standard Deviation 1820
|
2484 min*ug/mL
Standard Deviation 2182
|
Adverse Events
Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension
TOBREX®
TOBRADEX®
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension
n=21 participants at risk
Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension
|
TOBREX®
n=21 participants at risk
TOBREX® Ophthalmic Solution
|
TOBRADEX®
n=21 participants at risk
TOBRADEX® Ophthalmic Suspension
|
|---|---|---|---|
|
Eye disorders
Dry Eye
|
0.00%
0/21
|
0.00%
0/21
|
9.5%
2/21 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place