Corneal Barrier Function With Multi-Purpose Solutions | NCT00407238

Studies
Corneal Barrier Function With Multi-Purpose Solutions

NCT00407238

Sponsor

Southern California College of Optometry at Marshall B. Ketchum University

Status

Completed

Last Update Posted

Oct 23, 2007Estimated

Enrollment

25Estimated

Phase

Not Applicable

Conditions

Contact Lens Care

Interventions

Multi-purpose solutions (polyquaternium-1 and PHMB)

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

Oct 2007

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

Nov 2006

Primary Completion Date

Not provided

Completion Date

Mar 2007Actual

First Submitted Date

Nov 17, 2006

First Submission Date that Met QC Criteria

Nov 30, 2006

First Posted Date

Dec 4, 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

Oct 21, 2007

Last Update Posted Date

Oct 23, 2007Estimated

Name	Class
Alcon Research	INDUSTRY

Description Module

Brief Summary

The purpose of this study is to evaluate the effect on epithelial barrier function of three emarketed multi-purpose solution applied to the human eye with hydrogel lenses as during normal regimen use.

Detailed Description

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

25Estimated

Name	Type	Description	Arm Group Labels	Other Names
Multi-purpose solutions (polyquaternium-1 and PHMB)	Device

Measure	Description	Time Frame
Ratio of fluorescein dye penetration rate of test eye vs. control

Measure	Description	Time Frame
Corneal fluorescein staining

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adapted daily soft contact lens wearers, at least 18 years of age, vision correctable to 20/40

Exclusion Criteria:

Ocular or systemic allergies, abnormalities of the cornea, active ocular infection, prior keratorefractive surgery, use of ocular medications

Accepts Healthy Volunteers

Yes

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
Jerry R Paugh, OD, PhD	Southern California College of Optometry at Marshall B. Ketchum University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Southern California College of Optometry		Fullerton	California	92831	United States