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

Tracking Information
First Received Date ^ICMJE	June 9, 2008
Last Updated Date	February 23, 2010
Start Date ^ICMJE	June 2008
Primary Completion Date	June 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 23, 2010)	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.
Original Primary Outcome Measures ^ICMJE (submitted: June 9, 2008)	Tobramycin Tear Concentrations [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00695435 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 23, 2010)	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.
Original Secondary Outcome Measures ^ICMJE (submitted: June 9, 2008)	Area under the Curve [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Tobramycin Tear Concentrations
Official Title ^ICMJE	Evaluation of Tobramycin Tear Concentrations of TOBRADEX® Ophthalmic Suspension, Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension Versus TOBREX® Ophthalmic Solution in Normal Volunteers
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Dry Eye
Intervention ^ICMJE	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
Study Arm (s)	Experimental: Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension Intervention: Drug: Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension Active Comparator: TOBREX® Ophthalmic Solution TOBREX® Ophthalmic Solution Intervention: Drug: TOBREX Ophthalmic Solution Active Comparator: TOBRADEX® Ophthalmic Suspension TOBRADEX® Ophthalmic Suspension Intervention: Drug: TOBRADEX Ophthalmic Suspension
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	21
Completion Date	Not Provided
Primary Completion Date	June 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00695435
Other Study ID Numbers ^ICMJE	C-08-33
Has Data Monitoring Committee	No
Responsible Party	Michael Brubaker, Alcon
Study Sponsor ^ICMJE	Alcon Research
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Alcon Research
Verification Date	February 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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