NCT00363623

Brief Summary

The primary purpose of this study is to investigate the performance of contact lens maintenance systems when used with silicone hydrogel contact lenses during daily wear over a period of 1 month.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2006

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

Study Start

First participant enrolled

August 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

March 21, 2008

Status Verified

February 1, 2007

First QC Date

August 10, 2006

Last Update Submit

March 20, 2008

Conditions

MyopiaHyperopia

Interventions

Silicone hydrogel contact lensDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Is correctable to at least 20/40 distance visual acuity in each eye with spherical contact lenses.
  • Is an experienced soft contact lens wearer for at least 1 month.
  • Has no clinically significant anterior eye findings.
  • Has no other active ocular disease.

You may not qualify if:

  • Requires concurrent ocular medication.
  • Eye surgery or injury within 12 weeks prior to enrolment.
  • Has any systemic disease or ocular abnormality that might interfere with contact lens wear
  • Has any pre-existing ocular irritation that would preclude contact lens fitting.
  • PMMA lens wear previous 6 months.
  • EW or CW in previous 1 month.
  • Hydrogen peroxide users
  • Latex sensitivity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Vision Research Australia

Carlton, Victoria, 3053, Australia

Location

MeSH Terms

Conditions

MyopiaHyperopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Carol Lakkis, BScOptom, PhD

    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
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 10, 2006

First Posted

August 15, 2006

Study Start

August 1, 2006

Study Completion

December 1, 2006

Last Updated

March 21, 2008

Record last verified: 2007-02

Locations

AU(1)