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Tobradex ST

Phase 3

Blepharitis | Small molecule | Ophthalmology |Alcon Inc.|Last Updated: Jun 11, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment122

FDA Designations

No designations recorded

Clinical trial landscape

Tobradex ST · 1 trial · 1 indication

Phase 3 1
NCT01102244A Study to Evaluate the Clinical Efficacy and Safety of Tobradex® ST Compared to Azasite® in the Treatment of Subjects With Moderate to Severe Chronic BlepharitisBlepharitis
COMPLETED122 Analytics
PHASE3COMPLETED
A Study to Evaluate the Clinical Efficacy and Safety of Tobradex® ST Compared to Azasite® in the Treatment of Subjects With Moderate to Severe Chronic Blepharitis
BlepharitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Global sign and symptom score for blepharitis
Day 15
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Tobradex STEXPERIMENTALtobramycin 0.3%, dexamethasone 0.05%
AzasiteACTIVE_COMPARATORazithromycin 1%

Interventions

NameTypeDescription
Tobradex STDRUGtobramycin / dexamethasone ophthalmic suspension 0.3%/0.05% 1 drop 4 times daily for 14 days
AzasiteDRUGazithromycin 1% 1 drop twice daily for 2 days, then once daily for 12 days
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Eligibility Criteria

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

Inclusion Criteria: * Have diagnosis of moderate to severe chronic blepharitis defined by a minimum score of at least "1" for one of the lid signs, one of the conjunctival signs, and one of the symptoms in at least one eye * Have a minimum global score (the total signs and symptoms score) of 5 in t...

Countries:United States
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Competitive Landscape -Blepharitis 2 trials

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Frequently asked questions about Tobradex ST

What is Tobradex ST used for?

Tobradex ST is an investigational small molecule being developed for the treatment of moderate to severe chronic blepharitis, an inflammatory condition of the eyelids. It is administered as an ophthalmic formulation. The drug is currently in clinical development and has not been approved by regulatory authorities.

Who makes Tobradex ST?

Tobradex ST is being developed by Alcon Inc., a company traded on the New York Stock Exchange under the ticker symbol ALC. Alcon is a global medical device and pharmaceutical company specializing in eye care products, including treatments for various ophthalmic conditions.

What phase is Tobradex ST in?

Tobradex ST is in Phase 3 clinical development. It has completed one Phase 3 trial, which was an active-controlled study. The drug remains investigational and is not yet approved for commercial use. Further regulatory review and potential additional studies would be required before market approval.

What clinical trials is Tobradex ST in?

Tobradex ST has been evaluated in one completed Phase 3 clinical trial, registered as NCT01102244. This study assessed the clinical efficacy and safety of Tobradex ST compared to Azasite in 122 participants with moderate to severe chronic blepharitis. The trial was conducted in the United States and enrolled adults aged 18 years and older.

Is Tobradex ST the same as Tobradex?

Tobradex ST is a distinct formulation from standard Tobradex, though both are developed by Alcon. The 'ST' designation indicates a different formulation, which in this case is being studied specifically for chronic blepharitis. The Phase 3 trial compared Tobradex ST against Azasite, not against standard Tobradex.