Tobramycin Tear Concentrations

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.

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

  • 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

Interventions

  • 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

Primary 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.

Secondary Measures

  • 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

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Alcon Research
  • Provider of Information About this Clinical Study
    • Michael Brubaker, Alcon

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