Tobramycin Tear Concentrations

Alcon Research21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Dry Eye

Interventions

TOBRADEX Ophthalmic SuspensionDRUG

TOBRADEX Ophthalmic Suspension 1 drop each eye at baseline

Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic SuspensionDRUG

Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension 1 drop each eye at baseline

TOBREX Ophthalmic SolutionDRUG

TOBREX Ophthalmic Solution 1 drop each eye at baseline

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Contact Alcon Call Center For Trial Locations

Fort Worth, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 2, 4, 6, 12, and 18 minutes

Secondary Outcomes

Tobramycin Tear Concentration Area Under the Curve (AUC)

Trapezoidal AUC was calculated from 2 to 18 minutes.

Time frame: 2 to 18 minutes post administration

Data from ClinicalTrials.gov

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