Dosage Study for Vigamox Eye Drops Prior to Intravitreal... | NCT00690313

Studies
Dosage Study for Vigamox Eye Drops Prior to Intravitreal Injections

NCT00690313

Sponsor

Illinois Retina Associates

Status

Completed

Last Update Posted

Aug 7, 2019Actual

Enrollment

22Actual

Phase

Phase 4

Conditions

Intravitreal Injection Patients

Interventions

Vigamox

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

Aug 2019

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

Aug 2008

Primary Completion Date

Apr 2011Actual

Completion Date

Apr 2011Actual

First Submitted Date

May 30, 2008

First Submission Date that Met QC Criteria

Jun 3, 2008

First Posted Date

Jun 4, 2008Estimated

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

Aug 5, 2019

Last Update Posted Date

Aug 7, 2019Actual

Name	Class
Alcon Research	INDUSTRY

Description Module

Brief Summary

Antibiotic eye drops are being used before and after intravitreal injections. Currently there is no study indicating the benefit of there usage or their dosage.

In this study we compare the efficacy of Vigamox eye drops (antibiotic)starting 3 days prior to the injection versus 1 day prior to intravitreal injection.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Active Comparator	Arm 1: receives Vigamox eye drops 3Xday for 3 days prior to intravitreal injection	Drug: Vigamox
Arm 2	Active Comparator	Arm 2: receives Vigamox eye drops 3Xday for 1 day prior to intravitreal injection	Drug: Vigamox

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vigamox	Drug	eye drops 3 times day either 1 or 3 days prior to intravitreal injection	Arm 1 Arm 2

Measure	Description	Time Frame
Timed study		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient who need intravitreal injections patients who are willing to participate in the study

Exclusion Criteria:

Patients who are allergic to Vigamox or who have taken any eye drops within the past 3 weeks

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kourous A Rezaei, MD	Illinois Retina Associates SC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Illinois Retina Associates		Harvey	Illinois	60426	United States

Condition Browse Module

MeSH Terms

ID	Term
D008268	Macular Degeneration
D009877	Endophthalmitis

Ancestor Terms

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases
D015817	Eye Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077266	Moxifloxacin

Ancestor Terms

ID	Term
D024841	Fluoroquinolones
D042462	4-Quinolones
D015363	Quinolones
D011804	Quinolines

Browse Leaves

Not provided

Browse Branches

Not provided