Tobramycin Tear Concentrations

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Tobramycin Tear Concentrations of TOBRADEX® Ophthalmic Suspension, Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension Versus TOBREX® Ophthalmic Solution in Normal Volunteers

Conditions
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Dry Eye

Intervention / Treatment
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* Drug: TOBRADEX Ophthalmic Suspension
* Drug: Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension
* Drug: TOBREX Ophthalmic Solution


Participation Criteria
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Eligibility Criteria
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Inclusion: 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 Exclusion 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension<br>Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension | Drug: Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension<br>* Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension 1 drop each eye at baseline<br>|
| Active Comparator: TOBREX® Ophthalmic Solution<br>TOBREX® Ophthalmic Solution | Drug: TOBREX Ophthalmic Solution<br>* TOBREX Ophthalmic Solution 1 drop each eye at baseline<br>|
| Active Comparator: TOBRADEX® Ophthalmic Suspension<br>TOBRADEX® Ophthalmic Suspension | Drug: TOBRADEX Ophthalmic Suspension<br>* TOBRADEX Ophthalmic Suspension 1 drop each eye at baseline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tobramycin Tear Concentration Cmax (Maximum Concentration) | 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. | 2, 4, 6, 12, and 18 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tobramycin Tear Concentration Area Under the Curve (AUC) | Trapezoidal AUC was calculated from 2 to 18 minutes. | 2 to 18 minutes post administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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normal volunteers, anti-infective, tobramycin