Back to results

A Bioequivalence Study of Tobradex AF

Primary Purpose

Cataract

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Tobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspension

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

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18 or older Other protocol-defined inclusion criteria may apply Exclusion Criteria: Under 18 Other protocol-defined exclusion criteria may apply

Sites / Locations

Contact Alcon for Trial Location(s)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tobradex AF

TOBRADEX

Arm Description

Outcomes

Primary Outcome Measures

Concentration of dexamethasone in aqueous humor following a single topical ocular administration

Secondary Outcome Measures

Full Information

NCT ID

NCT00362895

First Posted

August 9, 2006

Last Updated

March 2, 2012

Sponsor

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT00362895

Brief Title

A Bioequivalence Study of Tobradex AF

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Completed

Study Start Date

April 2006 (undefined)

Primary Completion Date

August 2006 (Actual)

Study Completion Date

August 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alcon Research

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

995 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tobradex AF

Arm Type

Experimental

Arm Title

TOBRADEX

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Tobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspension

Intervention Description

One drop in the study eye, single dose

Intervention Type

Drug

Intervention Name(s)

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

Other Intervention Name(s)

TOBRADEX®

Intervention Description

One drop in the study eye, single dose

Primary Outcome Measure Information:

Title

Concentration of dexamethasone in aqueous humor following a single topical ocular administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 or older Other protocol-defined inclusion criteria may apply Exclusion Criteria: Under 18 Other protocol-defined exclusion criteria may apply

Facility Information:

Facility Name

Contact Alcon for Trial Location(s)

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76134

Country

United States

12. IPD Sharing Statement

Learn more about this trial

A Bioequivalence Study of Tobradex AF

We'll reach out to this number within 24 hrs