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Evaluation of the Performance of Non-molded Soft Contact Lenses

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00371787
First Posted: September 4, 2006
Last Update Posted: January 10, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
CIBA VISION
Information provided by:
University of Waterloo
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.

  • Visual Acuity [ Time Frame: 9 month ]
    level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.

  • Neovascularisation [ Time Frame: baseline ]
    length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.

  • Neovascularization [ Time Frame: 9 month ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   17 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Craig Woods, Research Manager, CCLR
ClinicalTrials.gov Identifier: NCT00371787     History of Changes
Other Study ID Numbers: P/240/06/CV
First Submitted: September 1, 2006
First Posted: September 4, 2006
Results First Submitted: November 8, 2010
Results First Posted: December 13, 2010
Last Update Posted: January 10, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases