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.
Full Title of Study: “Evaluation of Tobramycin Tear Concentrations of TOBRADEX® Ophthalmic Suspension, Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension Versus TOBREX® Ophthalmic Solution in Normal Volunteers”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: June 2008
- Drug: TOBRADEX Ophthalmic Suspension
- TOBRADEX Ophthalmic Suspension 1 drop each eye at baseline
- Drug: Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension
- Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension 1 drop each eye at baseline
- Drug: TOBREX Ophthalmic Solution
- TOBREX Ophthalmic Solution 1 drop each eye at baseline
Arms, Groups and Cohorts
- Experimental: Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension
- Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension
- Active Comparator: TOBREX® Ophthalmic Solution
- TOBREX® Ophthalmic Solution
- Active Comparator: TOBRADEX® Ophthalmic Suspension
- TOBRADEX® Ophthalmic Suspension
Clinical Trial Outcome Measures
- Tobramycin Tear Concentration Cmax (Maximum Concentration)
- Time Frame: 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.
- Tobramycin Tear Concentration Area Under the Curve (AUC)
- Time Frame: 2 to 18 minutes post administration
- Trapezoidal AUC was calculated from 2 to 18 minutes.
Participating in This Clinical Trial
- Visual Acuity (VA) of 0.6 logMAR or better
- Tear meniscus height of ≥ 0.3mm at Visit 1.
- No concomitant topical ocular medications, including artificial tears, during the study period
- ocular hypertension, iritis or uveitis, glaucoma
- ocular surgery, intraocular surgery or ocular laser procedures in either eye within the past six months
- epithelial herpes simplex (dendritic keratitis); Vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva; ocular Rosacea; Mycobacterial infection of the eye; and / or fungal disease of the eye
- lacrimal duct obstruction, dry eye, ocular allergies.
- contact lens within 7 days of Visit 1.
- ocular medications within 14 days of Visit 1.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Alcon Research
- Provider of Information About this Clinical Study
- Michael Brubaker, Alcon
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