Dispensing Overnight Study in Lenses | NCT00349856

Studies
Dispensing Overnight Study in Lenses

NCT00349856

Sponsor

University of Waterloo

Status

Completed

Last Update Posted

Feb 18, 2009Estimated

Enrollment

40Actual

Phase

Phase 3

Conditions

Myopia

Interventions

Biofinity

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

Jan 2005

Primary Completion Date

Mar 2008Actual

Completion Date

Mar 2008Actual

First Submitted Date

Jul 5, 2006

First Submission Date that Met QC Criteria

Jul 5, 2006

First Posted Date

Jul 10, 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

Feb 17, 2009

Last Update Posted Date

Feb 18, 2009Estimated

Name	Class
Cooper Companies	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 the study is to evaluate the fit and performance of an investigational soft contact lens in comparison with a currently marketed lens. Both lenses will be worn on a continuous wear basis, which means the lenses will be worn while sleeping.

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

40Actual

Label	Type	Description	Intervention Names
1	Active Comparator		Device: Biofinity

Name	Type	Description	Arm Group Labels	Other Names
Biofinity	Device	Soft contact lens	1	Purevision

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary objective of this trial is to assess safety of the investigational		study visits, three monthly

Secondary Outcomes

Measure	Description	Time Frame
The secondary objective of this trial is to assess the subjective responses to comfort with both the investigational and marketed lenses.		study visits, three monthly

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Has had an oculo-visual examination in the last 2 years.
Is between 18-45 years old and has full legal capacity to volunteer.
Has read and understood the Information Consent Letter
Is willing and able to follow participant instructions for product usage and meet the protocol-specified schedule of follow-up visits.
Is correctable with the prescription of the available lenses (-1.00 to -4.00 DS in 0.50D step).
Is correctable to at least 20/40 distance visual acuity with contact lenses in each eye.
Is a current soft contact lens wearer (both daily wear and extended wear experience allowed).
Has refractive astigmatism of <= 1.00 diopters
Has clear corneas and ocular clinical findings considered to be "normal".

Exclusion Criteria:

Has any systemic disease affecting ocular health.
Is using any systemic or topical medications that will affect ocular health.
Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.
Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities.
Has limbal injection, bulbar injection or corneal staining that, in the Investigator's opinion, is clinically significant.
Has never worn contact lenses before.
Has corneal distortion resulting from rigid lens wear.
Is aphakic.
Has undergone corneal refractive surgery.
Is participating in any other type of clinical or research study.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases