Investigation of the Clinical Performance of Silicone Hyd... | NCT00346593

Studies
Investigation of the Clinical Performance of Silicone Hydrogel Contact Lenses During Continuous Wear

NCT00346593

Sponsor

University of Melbourne

Status

Completed

Last Update Posted

Feb 12, 2007Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Myopia

Interventions

Silicone hydrogel contact lens

Countries

Australia

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 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

May 2004

Primary Completion Date

Not provided

Completion Date

Dec 2006

First Submitted Date

Jun 29, 2006

First Submission Date that Met QC Criteria

Jun 29, 2006

First Posted Date

Jun 30, 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 8, 2007

Last Update Posted Date

Feb 12, 2007Estimated

Name	Class
Clinical Vision Research Australia	OTHER
Cooper Companies	INDUSTRY

Description Module

Brief Summary

The primary purpose of this study is to investigate the clinical performance of a new silicone hydrogel contact lens during continuous wear (up to 30 nights) over a period of 24 months.

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

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Silicone hydrogel contact lens	Device

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Has had an oculo-visual examination in the last 2 years.
Is correctable to at least 6/7.5 distance visual acuity in each eye with spherical contact lenses.
Is a current soft contact lens wearer.
Has no clinically significant anterior eye findings.
Has no other active ocular disease.

Exclusion Criteria:

Has any systemic disease that might interfere with contact lens wear
Is using any systemic or topical medications that will affect ocular health.
Has any pre-existing ocular irritation that would preclude contact lens fitting.
Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.
Has undergone corneal refractive surgery.
Is pregnant, lactating or planning a pregnancy.

Accepts Healthy Volunteers

Not provided

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carol Lakkis, BScOptom PhD	Clinical Vision Research Australia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Vision Research Australia		Carlton	Victoria	3053	Australia

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases