NCT00404937

Brief Summary

The purpose of this study is to compare the new formulation of Tobradex to the current approved formulation

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2006

Status
withdrawn

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

First Submitted

Initial submission to the registry

November 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 29, 2006

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

March 6, 2012

Status Verified

September 1, 2007

Enrollment Period

Same day

First QC Date

November 28, 2006

Last Update Submit

March 3, 2012

Conditions

Post-surgical Inflammation

Outcome Measures

Primary Outcomes (1)

  • Anterior chamber inflammation

Secondary Outcomes (4)

  • Aqueous cells and flare

  • ocular pain

  • physician's impression of infection

  • frequency of treatment failures

Interventions

Tobradex (Antibiotic steroid combination)DRUG

Eligibility Criteria

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

You may qualify if:

  • Patients scheduled for cataract extraction

You may not qualify if:

  • Under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Tobramycin, Dexamethasone Drug Combination

Intervention Hierarchy (Ancestors)

DexamethasonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedTobramycinNebramycinKanamycinAminoglycosidesGlycosidesCarbohydratesDrug CombinationsPharmaceutical Preparations
0

Study Design

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

Study Record Dates

First Submitted

November 28, 2006

First Posted

November 29, 2006

Study Start

December 1, 2006

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

March 6, 2012

Record last verified: 2007-09