A Bioequivalence Study of Tobradex AF

NCT ID: NCT00362895

Last Updated: 2012-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 995 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2006-08-31

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.

Conditions

Cataract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Tobradex AF

Group Type: EXPERIMENTAL

Tobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspension

Intervention Type: DRUG

One drop in the study eye, single dose

TOBRADEX

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

One drop in the study eye, single dose

Interventions

Tobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspension

One drop in the study eye, single dose

Intervention Type: DRUG

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

One drop in the study eye, single dose

Intervention Type: DRUG

Other Intervention Names

TOBRADEX®

Eligibility Criteria

Inclusion Criteria

• 18 or older

Exclusion Criteria

• Under 18

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Contact Alcon for Trial Location(s)

Fort Worth, Texas, United States

Countries

United States

Other Identifiers

C-05-23

Identifier Type: -

Identifier Source: org_study_id