Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tobramycin 0.3%/ Dexamethasone 0.05% · 2 trials · 2 indications
Microbiological success was declared if the pre-therapy pathogens were eradicated at the Exit Visit; conversely, microbiological failure was declared if pre-therapy pathogens persisted at the exit visit. The microbiological outcomes were calculated based on an algorithm that assessed whether pre-therapy pathogens were eradicated or persisted as demonstrated by comparative characterization of recovered bacteria.
| Arm | Type | Description |
|---|---|---|
| Tobramycin 0.3%/Dexamethasone 0.05% | EXPERIMENTAL | Tobramycin 0.3%/Dexamethasone 0.05% 1 drop 4 times daily in both eyes |
| TOBRADEX | ACTIVE_COMPARATOR | TOBRADEX 1 drop 4 times daily in both eyes |
| Tobradex AF | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Tobramycin 0.3%/Dexamethasone 0.05% | DRUG | Tobramycin 0.3%/Dexamethasone 0.05% 1 drop in both eyes 4 times daily for at least 3 days |
| TOBRADEX | DRUG | TOBRADEX 1 drop in both eyes 4 times daily for at least 3 days |
| Tobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspension | DRUG | One drop in the study eye, single dose |
| Tobramycin 0.3% / Dexamethasone 0.1% ophthalmic suspension (TOBRADEX) | DRUG | One drop in the study eye, single dose |
Inclusion Criteria: * Ocular inflammation associated with blepharaconjunctivitis Exclusion Criteria: * ocular allergy * ocular disorders that would preclude safe administration of test article
Tobramycin 0.3%/Dexamethasone 0.05% is an ophthalmic suspension used for ocular inflammation associated with blepharoconjunctivitis. It combines an antibiotic and a corticosteroid to treat inflammation in the eye. The drug is currently in Phase 3 clinical development and is being studied for this specific condition.
Tobramycin 0.3%/Dexamethasone 0.05% is a combination product containing tobramycin, an aminoglycoside antibiotic that targets bacterial protein synthesis, and dexamethasone, a corticosteroid that reduces inflammation. The combination is designed to treat both the infectious and inflammatory components of blepharoconjunctivitis.
Tobramycin 0.3%/Dexamethasone 0.05% is being developed by Alcon Inc., a company traded on the New York Stock Exchange under the ticker ALC. Alcon is a global medical device company specializing in eye care products, and this drug is part of their ophthalmology portfolio.
Tobramycin 0.3%/Dexamethasone 0.05% is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial for this drug has been completed, and it is being studied for the treatment of ocular inflammation associated with blepharoconjunctivitis.
Tobramycin 0.3%/Dexamethasone 0.05% has one completed Phase 3 clinical trial registered under NCT00576251. The trial, titled 'TOBRADEX Ophthalmic Suspension Versus Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension,' enrolled 221 participants in the United States and was a randomized, double-blind, active-controlled study.