NCT00346593

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started May 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 30, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

February 12, 2007

Status Verified

February 1, 2007

First QC Date

June 29, 2006

Last Update Submit

February 8, 2007

Conditions

Myopia

Interventions

Silicone hydrogel contact lensDEVICE

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Vision Research Australia

Carlton, Victoria, 3053, Australia

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Carol Lakkis, BScOptom PhD

    Clinical Vision Research Australia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 29, 2006

First Posted

June 30, 2006

Study Start

May 1, 2004

Study Completion

December 1, 2006

Last Updated

February 12, 2007

Record last verified: 2007-02

Locations

AU(1)