A Clinical Study of Tobradex AF

July 28, 2008 updated by: Alcon Research

The purpose of this 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.

Study Overview

Status

Completed

Conditions

Cataract

Intervention / Treatment

Drug: Tobradex AF

Study Type

Interventional

Enrollment (Anticipated)

900

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Pennsylvania
  - Pittsburgh, Pennsylvania, United States, 15122
    - Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Adult patients requiring cataract surgery

Exclusion Criteria:

Age related

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Concentration of dexamethasone in aqueous humor following a single topical ocular administration Time Frame: Periodic	Periodic

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in external and internal ocular structures, intraocular pressure, vision and other side effects Time Frame: Periodic	Periodic

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

Study Director: Robert Faulkner, Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

May 10, 2007

First Submitted That Met QC Criteria