Recent Updates
Recently added Catalysts

TOBRADEX

Phase 1

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

Clinical trial landscape

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
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about TOBRADEX

What is TOBRADEX used for in Dry Eye?

TOBRADEX is an investigational small molecule being studied for the treatment of Dry Eye. It is currently in Phase 1 clinical development. The drug is being developed by Alcon Inc. (NYSE: ALC) for use in ophthalmology.

What does TOBRADEX target?

The molecular target of TOBRADEX has not been disclosed. It is a small molecule being investigated for Dry Eye, but its specific mechanism of action is not publicly available at this time.

Who makes TOBRADEX?

TOBRADEX is being developed by Alcon Inc., a company traded on the New York Stock Exchange under the ticker symbol ALC. Alcon is focused on ophthalmology products, and TOBRADEX is one of its investigational assets for Dry Eye.

What phase is TOBRADEX in?

TOBRADEX is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for Dry Eye, and the Phase 1 trial has been completed.

What clinical trials is TOBRADEX in?

TOBRADEX has one completed Phase 1 clinical trial, NCT00695435, titled 'Tobramycin Tear Concentrations.' The study enrolled 21 participants with Dry Eye in the United States. It was a randomized, double-blind, active-controlled trial involving healthy volunteers aged 18 years and older.

Is TOBRADEX the same as Tobramycin?

TOBRADEX is a combination product that contains tobramycin, an antibiotic, and dexamethasone, a corticosteroid. While tobramycin is one of its active ingredients, TOBRADEX is a distinct drug product. The Phase 1 trial for Dry Eye measured tobramycin tear concentrations.