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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014