Tobramycin Tear Concentrations
Evaluation of Tobramycin Tear Concentrations of TOBRADEX® Ophthalmic Suspension, Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension Versus TOBREX® Ophthalmic Solution in Normal Volunteers
1 other identifier
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 9, 2008
CompletedFirst Posted
Study publicly available on registry
June 11, 2008
CompletedResults Posted
Study results publicly available
February 5, 2010
CompletedMarch 2, 2010
February 1, 2010
Same day
June 9, 2008
April 27, 2009
February 23, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tobramycin Tear Concentration Cmax (Maximum Concentration)
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 Outcomes (1)
Tobramycin Tear Concentration Area Under the Curve (AUC)
2 to 18 minutes post administration
Study Arms (3)
Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension
EXPERIMENTALTobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension
TOBREX® Ophthalmic Solution
ACTIVE COMPARATORTOBREX® Ophthalmic Solution
TOBRADEX® Ophthalmic Suspension
ACTIVE COMPARATORTOBRADEX® Ophthalmic Suspension
Interventions
TOBRADEX Ophthalmic Suspension 1 drop each eye at baseline
Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension 1 drop each eye at baseline
TOBREX Ophthalmic Solution 1 drop each eye at baseline
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (1)
Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, 76134, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alcon Clinical
- Organization
- Alcon Research, LTD
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 9, 2008
First Posted
June 11, 2008
Study Start
June 1, 2008
Primary Completion
June 1, 2008
Last Updated
March 2, 2010
Results First Posted
February 5, 2010
Record last verified: 2010-02