Comparison of OPTI-FREE RepleniSH and ReNu Multi-Plus Len... | NCT00724269

Studies
Comparison of OPTI-FREE RepleniSH and ReNu Multi-Plus Lens Care Regimens on Corneal Epithelium

NCT00724269

Sponsor

Alcon Research

Status

Completed

Last Update Posted

Oct 1, 2012Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Contact Lens Wear

Interventions

OPTI-FREE RepleniSH
ReNu MultiPlus MPS

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

Nov 2011

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 2009

Primary Completion Date

Jul 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

Jul 25, 2008

First Submission Date that Met QC Criteria

Jul 28, 2008

First Posted Date

Jul 29, 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

Sep 28, 2012

Last Update Posted Date

Oct 1, 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 corneal epithelium after soft contact lens wear and use of two marketed multi-purpose solutions.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Opti Free RepliniSH	Active Comparator	Opti Free RepliniSH	Device: OPTI-FREE RepleniSH
ReNu Multi-Plus	Active Comparator	ReNu Multi-Plus	Device: ReNu MultiPlus MPS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OPTI-FREE RepleniSH	Device	Multi-Purpose Solution for soft contact lenses	Opti Free RepliniSH

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Confocal microscopy analysis of Corneal Epithelium		2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Patient comfort		2 weeks
Corneal Staining		2 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Successful contact lens wear on a daily wear basis
Wear contact lenses at least 8 hours/day
Vision correctable to at least 20/30
Normal Eyes
Other protocol-defined inclusion criteria may apply

Exclusion:

Topical ocular medication use
Other protocol-defined inclusion 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 Call Center for Study Locations		Fort Worth	Texas	76134	United States