Multipurpose Disinfecting Solution Compatibility With a S... | NCT00520689

Studies
Multipurpose Disinfecting Solution Compatibility With a Silicone Hydrogel Contact Lens

NCT00520689

Sponsor

University of Waterloo

Status

Completed

Last Update Posted

Feb 16, 2009Estimated

Enrollment

25Actual

Phase

Phase 3

Conditions

Myopia
Hyperopia

Interventions

Silicone Hydrogel Contact Lens

Countries

Canada

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

Feb 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

Sep 2007

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Aug 22, 2007

First Submission Date that Met QC Criteria

Aug 22, 2007

First Posted Date

Aug 24, 2007Estimated

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

Feb 12, 2009

Last Update Posted Date

Feb 16, 2009Estimated

Name	Class
Menicon Co., Ltd.	INDUSTRY

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 verify the compatibility of a silicone hydrogel lens when used with four multipurpose disinfecting solutions (OPTI-FREE® RepleniSH®, ReNu MultiPlus®, Solo-Care Aqua™ and MeniCareTM Soft).

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
1	Active Comparator	Device: Silicone Hydrogel Contact Lens
2	Active Comparator	Device: Silicone Hydrogel Contact Lens
3	Active Comparator	Device: Silicone Hydrogel Contact Lens
4	Active Comparator	Device: Silicone Hydrogel Contact Lens

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Silicone Hydrogel Contact Lens	Device	use of lens over 2 days	1 2 3 4

Measure	Description	Time Frame
To see if there are any effects on the cornea when using each contact lens/solution combination.		Over 2 days

Measure	Description	Time Frame
To quantify comfort and vision ratings with each lens/solution combination.		over 2 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

Is at least 17 years old and has full legal capacity to volunteer
Has read and signed an information consent letter, after having the opportunity to ask questions and receive acceptable answers
Is willing and able to follow instructions and maintain the study appointment schedule
Is correctable to a visual acuity of 6/7.5 (20/25) or better (both eyes) with their habitual vision correction
Has normal binocular vision (no strabismus, no amblyopia, and anisometropia less than or equal to 1.00 D)
Has clear corneas and no active ocular disease
Has had an ocular examination in the last two years.
Has a functional pair of spectacles
Is a current soft lens wearer replacing their lenses at least monthly
Has a distance contact lens prescription between +6.00D to -10.00 DS and can be successfully fitted with the study lens
Has astigmatism less than or equal to -1.00DC
Agrees to wear the study lenses on a daily wear basis

Exclusion Criteria:

A person will be excluded from the study if he/she:

Has any signs or symptoms of dry eye
Has any clinically significant blepharitis
Has undergone corneal refractive surgery
Is aphakic
Has any systemic disease affecting ocular health
Is using any systemic or topical medications that may affect ocular health
Is pregnant or lactating
Is participating in any other type of clinical or research study
Currently wears daily disposable lenses
Currently wears lenses on a continuous or extended wear basis
Is unable to successfully wear contact lenses without routinely using rewetting drops

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

55 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Desmond Fonn, M Optom	University of Waterloo	Principal Investigator
Craig Woods, PhD	University of Waterloo	Principal Investigator

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

ID	Term
D009216	Myopia
D006956	Hyperopia