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Evaluation of the Performance of Non-molded Soft Contact Lenses

This study has been completed.
Sponsor:
Collaborator:
CIBA VISION
Information provided by:
University of Waterloo
ClinicalTrials.gov Identifier:
NCT00371787
First received: September 1, 2006
Last updated: January 5, 2011
Last verified: January 2011
History of Changes
  Purpose

To evaluate the performance of the study soft lens for vision, comfort, physiology and lens surface properties.


Condition Intervention Phase
Ametropia
 Device: Soft contact lens
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Performance of Non-molded Soft Contact Lenses

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Further study details as provided by University of Waterloo:

Primary Outcome Measures:
  • Visual Acuity [ Time Frame: baseline ] [ Designated as safety issue: No ]
    level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.

  • Visual Acuity [ Time Frame: 9 month ] [ Designated as safety issue: No ]
    level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.

  • Neovascularisation [ Time Frame: baseline ] [ Designated as safety issue: No ]
    length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.

  • Neovascularization [ Time Frame: 9 month ] [ Designated as safety issue: No ]
    length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.


Enrollment: 38
Study Start Date: August 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: soft contact lens Device: Soft contact lens
Soft contact lens
Other Name: Custom O2Optix
No Intervention: non-lens wear
control group

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.

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00371787

Locations
Canada, Ontario
Centre for Contact Lens Research, University of Waterloo,
Waterloo, Ontario, Canada, N2L 3G1
Sponsors and Collaborators
University of Waterloo
CIBA VISION
Investigators
Principal Investigator: Desmond Fonn Centre for Contact Lens Research
  More Information

No publications provided

Responsible Party: Craig Woods, Research Manager, CCLR
ClinicalTrials.gov Identifier: NCT00371787     History of Changes
Other Study ID Numbers: P/240/06/CV
Study First Received: September 1, 2006
Results First Received: November 8, 2010
Last Updated: January 5, 2011
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on June 18, 2013