A Bioequivalence Study of Tobradex AF | NCT00362895

Studies
A Bioequivalence Study of Tobradex AF

NCT00362895

Sponsor

Alcon Research

Status

Completed

Last Update Posted

Mar 5, 2012Estimated

Enrollment

995Actual

Phase

Phase 3

Conditions

Cataract

Interventions

Tobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspension
Tobramycin 0.3% / Dexamethasone 0.1% ophthalmic suspension (TOBRADEX)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Aug 2006Actual

Completion Date

Aug 2006Actual

First Submitted Date

Aug 9, 2006

First Submission Date that Met QC Criteria

Aug 9, 2006

First Posted Date

Aug 15, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2012

Last Update Posted Date

Mar 5, 2012Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

995Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Tobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspension	Drug	One drop in the study eye, single dose	Tobradex AF

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Concentration of dexamethasone in aqueous humor following a single topical ocular administration

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Contact Alcon for Trial Location(s)		Fort Worth	Texas	76134	United States

Condition Browse Module

MeSH Terms

ID	Term
D002386	Cataract

Ancestor Terms

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014031	Tobramycin
D003907	Dexamethasone
D000078162	Tobramycin, Dexamethasone Drug Combination

Ancestor Terms

ID	Term
D009328	Nebramycin
D007612	Kanamycin
D000617	Aminoglycosides
D006027	Glycosides
D002241

Browse Leaves

Not provided

Browse Branches

Not provided