Tobramycin Tear Concentrations

February 23, 2010 updated by: Alcon Research

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Worth, Texas, United States, 76134
        • Contact Alcon Call Center for Trial Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2, 4, 6, 12, and 18 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 to 18 minutes post administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

June 9, 2008

First Submitted That Met QC Criteria

June 9, 2008

First Posted (Estimate)

June 11, 2008

Study Record Updates

Last Update Posted (Estimate)

March 2, 2010

Last Update Submitted That Met QC Criteria

February 23, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-08-33

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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