Comparison of 3 Novel Contact Lens Solutions on the Basal... | NCT00691457

Studies
Comparison of 3 Novel Contact Lens Solutions on the Basal Lamina

NCT00691457

Sponsor

Alcon Research

Status

Completed

Last Update Posted

Oct 1, 2012Estimated

Enrollment

15Actual

Phase

Not Applicable

Conditions

Contact Lens Solution

Interventions

Opti-Free contact lens solution
ReNu Multiplus contact lens solution
Clear Care contact lens solution

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

Jun 2009

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 2008

Primary Completion Date

Jan 2009Actual

Completion Date

Jan 2009Actual

First Submitted Date

Jun 3, 2008

First Submission Date that Met QC Criteria

Jun 4, 2008

First Posted Date

Jun 5, 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

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

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Opti-Free contact lens solution	Device: Opti-Free contact lens solution
2	Active Comparator	ReNu Multiplus contact lens solution	Device: ReNu Multiplus contact lens solution
3	Active Comparator	Clear Care contact lens solution	Device: Clear Care contact lens solution

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Opti-Free contact lens solution	Device	Solution	1
ReNu Multiplus contact lens solution

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in corneal fluorescein staining as evaluated at Day 30		30 Days

Secondary Outcomes

Measure	Description	Time Frame
Confocal evaluation variables as measured at Days 0, 14, and 30		Day 0, 14, 30

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion:

Stable distance contact lens prescription between -0.50 D and 9.00 D and astigmatism less than or equal to -1.00 D cylindrical (cyl).
Stable correction is defined as longer than six months.
Worn a single brand of disposable silicone hydrogel contact lenses successfully (i.e., without complications or discomfort) for a minimum of six months

Exclusion:

Known sensitivity to the contact lens disinfecting solutions or fluorescein dye.
Any systemic or ocular disease that could affect contact lens wear.
Women who are pregnant or lactating.

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
Virginia Beach, VA		Virginia Beach	Virginia	23462	United States