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

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

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study

Study Primary Completion Date: June 2008

Intervention(s) in this Clinical Trial

• Drug: TOBRADEX Ophthalmic Suspension
  • Ophthalmic suspension

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 2
  • Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension
• Active Comparator: 3
  • TOBREX® Ophthalmic Solution
• Experimental: 1
  • TOBRADEX® Ophthalmic Suspension

Primary Measures

• Tobramycin Tear Concentrations
  • Time Frame: 3 days
    Safety Issue?: No

Secondary Measures

• Area under the Curve
  • Time Frame: Baseline
    Safety Issue?: No

Inclusion:

• 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 for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Alcon Research

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00695435

Study ID Number: C-08-33

ClinicalTrials.gov Identifier: NCT00695435

Health Authority: United States: Food and Drug Administration