Tobramycin Tear Concentrations
Phase 1
Completed
- Conditions
- Dry Eye
- Interventions
- Registration Number
- NCT00695435
- Lead Sponsor
- Alcon Research
- Brief Summary
To evaluate the Tobramycin tear concentration values of TOBRADEX® Ophthalmic Suspension, Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension versus TOBREX® Ophthalmic Solution in normal volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description TOBREX® Ophthalmic Solution TOBREX Ophthalmic Solution TOBREX® Ophthalmic Solution TOBRADEX® Ophthalmic Suspension TOBRADEX Ophthalmic Suspension TOBRADEX® Ophthalmic Suspension Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension
- Primary Outcome Measures
Name Time Method Tobramycin Tear Concentration Cmax (Maximum Concentration) 2, 4, 6, 12, and 18 minutes 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.
- Secondary Outcome Measures
Name Time Method Tobramycin Tear Concentration Area Under the Curve (AUC) 2 to 18 minutes post administration Trapezoidal AUC was calculated from 2 to 18 minutes.
Trial Locations
- Locations (1)
Contact Alcon Call Center For Trial Locations
🇺🇸Fort Worth, Texas, United States