NCT00362895

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
995

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2006

Shorter than P25 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

April 1, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2006

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 15, 2006

Completed
Last Updated

March 5, 2012

Status Verified

March 1, 2012

Enrollment Period

4 months

First QC Date

August 9, 2006

Last Update Submit

March 2, 2012

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

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

Study Arms (2)

Tobradex AF

EXPERIMENTAL
Drug: Tobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspension

TOBRADEX

ACTIVE COMPARATOR
Drug: Tobramycin 0.3% / Dexamethasone 0.1% ophthalmic suspension (TOBRADEX)

Interventions

Tobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspensionDRUG

One drop in the study eye, single dose

Tobradex AF
Tobramycin 0.3% / Dexamethasone 0.1% ophthalmic suspension (TOBRADEX)DRUG

One drop in the study eye, single dose

Also known as: TOBRADEX®
TOBRADEX

Eligibility Criteria

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

You may qualify if:

  • or older

You may not qualify if:

  • Under 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Contact Alcon for Trial Location(s)

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Cataract

Interventions

TobramycinDexamethasoneTobramycin, Dexamethasone Drug Combination

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

NebramycinKanamycinAminoglycosidesGlycosidesCarbohydratesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedDrug CombinationsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2006

First Posted

August 15, 2006

Study Start

April 1, 2006

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

March 5, 2012

Record last verified: 2012-03

Locations

US(1)