Evaluation of the Performance of Non-molded Soft Contact Lenses

January 5, 2011 updated by: University of Waterloo
To evaluate the performance of the study soft lens for vision, comfort, physiology and lens surface properties.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To evaluate the performance of the study soft lens for vision, comfort, physiology and lens surface properties in a group of participants who present with lens related changes.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Waterloo, Ontario, Canada, N2L 3G1
        • Centre for Contact Lens Research, University of Waterloo,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, good health, age >17yrs, able to wear contact lenses as primary vision correction, able to see well and achieve good fit with study lens, has understood & signed consent form.

Exclusion Criteria:

  • Has active ocular disease, uses topical eye medication, wears gas permeable/silicone hydrogel /overnight wear contact lenses, is a participant in another clinical study, is deemed unsuitable for soft contact lens wear.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: soft contact lens
Device: Soft contact lens
Soft contact lens
Other Names:
  • Custom O2Optix
No Intervention: non-lens wear
control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity
Time Frame: baseline
level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.
baseline
Visual Acuity
Time Frame: 9 month
level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.
9 month
Neovascularisation
Time Frame: baseline
length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.
baseline
Neovascularization
Time Frame: 9 month
length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.
9 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Waterloo

Collaborators

CIBA VISION

Investigators

  • Principal Investigator: Desmond Fonn, Centre for Contact Lens Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

September 1, 2006

First Submitted That Met QC Criteria

September 1, 2006

First Posted (Estimate)

September 4, 2006

Study Record Updates

Last Update Posted (Estimate)

January 10, 2011

Last Update Submitted That Met QC Criteria

January 5, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/240/06/CV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe