Phase 3 N=221 Randomized Quadruple-blind Treatment

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

Ocular Inflammation Associated With Blepharaconjunctivitis

Bottom Line

View on ClinicalTrials.gov: NCT00576251 ↗

Enrolled (actual)

221

Serious AEs

0.0%

Results posted

Jan 2010

Primary outcome: Primary: Percent of Patients Who Display Microbiological Success (Eradication of Baseline Pathogens at Day 4) — 100.0; 94.4 Percent of patients

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Tobramycin 0.3%/Dexamethasone 0.05% (Drug); TOBRADEX (Drug)
Age: Pediatric, Adult, Older Adult · 2+ yrs
Sex: All
Sponsor: Alcon Research
Primary completion: Feb 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent of Patients Who Display Microbiological Success (Eradication of Baseline Pathogens at Day 4)	100.0; 94.4	—

Summary

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

Eligibility Criteria

Inclusion Criteria

Ocular inflammation associated with blepharaconjunctivitis

Exclusion Criteria

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

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Data sourced from ClinicalTrials.gov (NCT00576251). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.