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Evaluation of the Performance of Non-molded Soft Contact Lenses

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.
ClinicalTrials.gov Identifier: NCT00371787
Recruitment Status : Completed
First Posted : September 4, 2006
Results First Posted : December 13, 2010
Last Update Posted : January 10, 2011
Sponsor:
Collaborator:
CIBA VISION
Information provided by:
University of Waterloo

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

Condition or disease Intervention/treatment Phase
Ametropia Device: Soft contact lens Phase 3

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  (Clinical Trial)
Actual Enrollment : 38 participants
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
Study Start Date : August 2006
Primary Completion Date : December 2007
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: soft contact lens Device: Soft contact lens
Soft contact lens
Other Name: Custom O2Optix
No Intervention: non-lens wear
control group



Primary Outcome Measures :
  1. Visual Acuity [ Time Frame: baseline ]
    level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.

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

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

  4. Neovascularization [ Time Frame: 9 month ]
    length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.



Information from the National Library of Medicine

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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.

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

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

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases