NCT00441233

Brief Summary

The primary purpose of this study is to investigate the clinical performance of a new silicone hydrogel contact lens over a period of 6 months of extended wear.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Mar 2007

Shorter than P25 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

First Submitted

Initial submission to the registry

February 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 28, 2007

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

January 9, 2008

Status Verified

December 1, 2007

Enrollment Period

8 months

First QC Date

February 27, 2007

Last Update Submit

December 27, 2007

Conditions

Myopia

Interventions

Silicone hydrogel contact lensDEVICE

Eligibility Criteria

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

You may qualify if:

  • Is correctable to at least 6/9 distance visual acuity in each eye with spherical contact lenses.
  • Is a current daily wear 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

Melbourne, Victoria, 3053, Australia

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Carol Lakkis, BScOptom, PhD, PGCertOcTher

    Clinical Vision Research Australia, University of Melbourne

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 27, 2007

First Posted

February 28, 2007

Study Start

March 1, 2007

Primary Completion

November 1, 2007

Study Completion

December 1, 2007

Last Updated

January 9, 2008

Record last verified: 2007-12

Locations

AU(1)