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Tobramycin Tear Concentrations

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00695435
First received: June 9, 2008
Last updated: February 23, 2010
Last verified: February 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Dry Eye
 Drug: TOBRADEX Ophthalmic Suspension
Drug: Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension
Drug: TOBREX Ophthalmic Solution
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Tobramycin Tear Concentration Cmax (Maximum Concentration) [ Time Frame: 2, 4, 6, 12, and 18 minutes ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Tobramycin Tear Concentration Area Under the Curve (AUC) [ Time Frame: 2 to 18 minutes post administration ] [ Designated as safety issue: No ]
    Trapezoidal AUC was calculated from 2 to 18 minutes.


Enrollment: 21
Study Start Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension
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
TOBREX® Ophthalmic Solution
 Drug: TOBREX Ophthalmic Solution
TOBREX Ophthalmic Solution 1 drop each eye at baseline
Active Comparator: TOBRADEX® Ophthalmic Suspension
TOBRADEX® Ophthalmic Suspension
 Drug: TOBRADEX Ophthalmic Suspension
TOBRADEX Ophthalmic Suspension 1 drop each eye at baseline

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00695435

Locations
United States, Texas
Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Michael Brubaker, Alcon
ClinicalTrials.gov Identifier: NCT00695435     History of Changes
Other Study ID Numbers: C-08-33
Study First Received: June 9, 2008
Results First Received: April 27, 2009
Last Updated: February 23, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
normal volunteers
anti-infective
tobramycin

Additional relevant MeSH terms:
Tobramycin
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013