A Bioequivalence Study of Tobradex AF

A Double-Masked, Parallel-Group, Randomized, Single-Dose Bioequivalence Study of Tobradex AF Suspension and TOBRADEX Ophthalmic Suspension

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00362895

Enrollment

995

Registered

2006-08-15

Start date

2006-04-30

Completion date

2006-08-31

Last updated

2012-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Brief summary

The purpose of the study is to determine the amount of study medication that moves from the front of the eye into the fluid at the front of the inside of the eye.

Interventions

DRUGTobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspension

One drop in the study eye, single dose

DRUGTobramycin 0.3% / Dexamethasone 0.1% ophthalmic suspension (TOBRADEX)

One drop in the study eye, single dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 18 or older * Other protocol-defined inclusion criteria may apply

Exclusion criteria

* Under 18 * Other protocol-defined

Design outcomes

Primary

Measure	Time frame
Concentration of dexamethasone in aqueous humor following a single topical ocular administration	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026