TOBRADEX Ophthalmic Suspension Versus Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension

Alcon

Status and phase: Completed; Phase 3

Conditions: Ocular Inflammation Associated With Blepharaconjunctivitis

Treatments: Drug: TOBRADEX; Drug: Tobramycin 0.3%/Dexamethasone 0.05%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00576251

C-07-19

Details and patient eligibility

About

The purpose of this study is to describe the differences in efficacy between TOBRADEX Ophthalmic Suspension and Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension in the treatment of ocular inflammation and infection associated with blepharaconjunctivitis

Enrollment: 221 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ocular inflammation associated with blepharaconjunctivitis

Exclusion criteria

• ocular allergy
• ocular disorders that would preclude safe administration of test article

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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221 participants in 2 patient groups

Tobramycin 0.3%/Dexamethasone 0.05%

Experimental group

Description:

Tobramycin 0.3%/Dexamethasone 0.05% 1 drop 4 times daily in both eyes

Treatment:

Drug: Tobramycin 0.3%/Dexamethasone 0.05%

TOBRADEX

Active Comparator group

Description:

TOBRADEX 1 drop 4 times daily in both eyes

Treatment:

Drug: TOBRADEX