Next Generation Ophthalmic Irrigating Solution Posterior... | NCT00333203

Studies
Next Generation Ophthalmic Irrigating Solution Posterior Segment Study

NCT00333203

Sponsor

Alcon Research

Status

Completed

Last Update Posted

Mar 5, 2012Estimated

Enrollment

369Actual

Phase

Phase 3

Conditions

Eye Diseases

Interventions

Next Generation Ophthalmic Irrigating Solution (NGOIS)
BSS Plus

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

Oct 2005

Primary Completion Date

Mar 2006Actual

Completion Date

Mar 2006Actual

First Submitted Date

Jun 1, 2006

First Submission Date that Met QC Criteria

Jun 1, 2006

First Posted Date

Jun 2, 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 1, 2012

Last Update Posted Date

Mar 5, 2012Estimated

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 this study is to evaluate the safety of Next Generation Ophthalmic Irrigating Solution (NGOIS) compared to BSS PLUS for use during surgery for removal of epimacular membrane and vitrectomy.

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

369Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NGOIS	Experimental		Drug: Next Generation Ophthalmic Irrigating Solution (NGOIS)
BSS Plus	Active Comparator		Other: BSS Plus

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Next Generation Ophthalmic Irrigating Solution (NGOIS)	Drug	Volume sufficient to irrigate adequately during cataract surgery	NGOIS

Measure	Description	Time Frame
Best-corrected logMAR visual acuity

Measure	Description	Time Frame
Intraocular pressure (IOP)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients of any race and sex, with an epimacular membrane who would benefit from vitrectomy and membrane removal.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Under 18 years of age.
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
United States		Fort Worth	Texas	76134	United States

Condition Browse Module

MeSH Terms

ID	Term
D005128	Eye Diseases
D019773	Epiretinal Membrane

Ancestor Terms

ID	Term
D012164	Retinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C013003	glutathione-bicarbonate-Ringer solution

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided