Using Device Delivering Ophthalmic Solution in a Spray Fo... | NCT00565630

Studies
Using Device Delivering Ophthalmic Solution in a Spray Form Instead of Eye Drops

NCT00565630

Sponsor

Advanced Ophthalmic Pharma

Status

Withdrawn

Last Update Posted

Feb 25, 2009Estimated

Enrollment

16Estimated

Phase

Not Applicable

Conditions

Cataract

Interventions

Vigamox delivered via the device in spray form

Countries

Not provided

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

ID	Type	Description	Link
TAMC 06-306

Status Module

Record Verification Date

Nov 2007

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Replaced with ongoing study

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Not provided

Completion Date

Mar 2008Estimated

First Submitted Date

Nov 28, 2007

First Submission Date that Met QC Criteria

Nov 29, 2007

First Posted Date

Nov 30, 2007Estimated

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

Feb 24, 2009

Last Update Posted Date

Feb 25, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study is to confirm that Vigamox reaches similar aqueous concentration when administered as the commercially available eye drops or as a spray delivered from a proprietary device.

Detailed Description

Patients scheduled for elective cataract surgery, will be randomly allocated to receive Vigamox 4 times , 1 hour prior to surgery, either via the experimental device in a spray form, or via the regular, commercially available bottle.

Aqueous sample will be collected and submitted to a masked laboratory for measuring Vigamox concentration.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Vigamox via the experiemntal device	Device: Vigamox delivered via the device in spray form
2	Active Comparator	Vigamox drops from the commercially available bottles	Device: Vigamox delivered via the device in spray form

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vigamox delivered via the device in spray form	Device	Vigamox delivered 4 times, 1 hour prior to cataract surgery	1 2

Measure	Description	Time Frame
Aqeous concentration of Vigamox		one month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients scheduled for elective cataract surgery

Exclusion Criteria:

Known allergy to quinolone compounds

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

Name	Affiliation	Role
Adi Michaeli, MD	Dept of Ophthalmology, TAMC, Tel Aviv, Israel	Principal Investigator

Locations

Not provided

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases