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TOBRADEX

Phase 3

Dry Eye | Small molecule | Ophthalmology |Alcon Inc.|Trials Updated: Mar 2, 2010

TOBRADEX development status

Highest phase Phase 3 (NCT00576251)
Phase scored for ALCPhase 1
Registered trials 1 across 1 sponsor since Dec 2007

TOBRADEX target and mechanism

ModalitySmall molecule

Also known as TOBRADEX Ophthalmic Suspension

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

TOBRADEX clinical trials

TOBRADEX · 1 trial · 1 indication

Phase 1 1
NCT00695435Tobramycin Tear ConcentrationsDry Eye
COMPLETED21 Analytics
PHASE1COMPLETED
Tobramycin Tear Concentrations
Dry EyeUnlock trial analytics

Study Endpoints

Primary Endpoints

Tobramycin Tear Concentration Cmax (Maximum Concentration)
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.

Secondary Endpoints

Tobramycin Tear Concentration Area Under the Curve (AUC)
2 to 18 minutes post administration
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic SuspensionEXPERIMENTALTobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension
TOBREX® Ophthalmic SolutionACTIVE_COMPARATORTOBREX® Ophthalmic Solution
TOBRADEX® Ophthalmic SuspensionACTIVE_COMPARATORTOBRADEX® Ophthalmic Suspension

Interventions

NameTypeDescription
TOBRADEX Ophthalmic SuspensionDRUGTOBRADEX Ophthalmic Suspension 1 drop each eye at baseline
Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic SuspensionDRUGTobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension 1 drop each eye at baseline
TOBREX Ophthalmic SolutionDRUGTOBREX Ophthalmic Solution 1 drop each eye at baseline
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:United States
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Frequently asked questions about TOBRADEX

What is TOBRADEX?

TOBRADEX is an ophthalmic suspension developed by Alcon Inc. (ticker ALC). It is being studied in a Phase 1 clinical program for dry eye, an ophthalmology condition. The formulation is a small molecule product, and it is also referred to as TOBRADEX Ophthalmic Suspension.

What is TOBRADEX used for?

TOBRADEX is being evaluated for dry eye. Its clinical development in this indication is at the Phase 1 stage, and the program includes one completed trial conducted in the United States. The drug is investigational for dry eye and is not described as approved for that use.

Who makes TOBRADEX?

TOBRADEX is developed by Alcon Inc., which trades under the ticker ALC. Alcon is the sponsor behind the clinical program evaluating the ophthalmic suspension in dry eye.

What phase is TOBRADEX in?

TOBRADEX is in Phase 1 development for dry eye. The program has one completed Phase 1 trial and no active trials. Because the available development stage is Phase 1, TOBRADEX is investigational and remains in clinical development rather than being an approved therapy.

What clinical trials is TOBRADEX in?

TOBRADEX has been studied in one completed Phase 1 trial, NCT00695435, titled Tobramycin Tear Concentrations. That trial enrolled 21 participants in the United States, used a randomized, double-blind, active-controlled design, and included healthy volunteers aged 18 years and older.

Is TOBRADEX the same as TOBRADEX Ophthalmic Suspension?

Yes. TOBRADEX Ophthalmic Suspension is another name for TOBRADEX. Both names refer to the same Alcon Inc. product, a small molecule ophthalmic suspension being studied in Phase 1 for dry eye.