NCT00473070

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2007

Completed
Last Updated

July 29, 2008

Status Verified

July 1, 2008

Enrollment Period

3 months

First QC Date

May 10, 2007

Last Update Submit

July 28, 2008

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

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

    Periodic

Secondary Outcomes (1)

  • Changes in external and internal ocular structures, intraocular pressure, vision and other side effects

    Periodic

Interventions

Tobradex AFDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients requiring cataract surgery

You may not qualify if:

  • Age related

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pittsburgh

Pittsburgh, Pennsylvania, 15122, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Robert Faulkner

    Alcon Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 10, 2007

First Posted

May 14, 2007

Study Start

November 1, 2006

Primary Completion

February 1, 2007

Last Updated

July 29, 2008

Record last verified: 2008-07

Locations

US(1)