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Performance Comparison Between Comfilcon A and Senofilcon C 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: NCT02920957
Recruitment Status : Completed
First Posted : September 30, 2016
Results First Posted : January 9, 2018
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.

Study Description
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Brief Summary:
The aim of this study is to determine the clinical performance of comfilcon A in comparison to senofilcon C.

Condition or disease Intervention/treatment Phase
Myopia Device: comfilcon A Device: senofilcon C Not Applicable

Detailed Description:
This is a prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, two month dispensing study comparing the clinical performance of comfilcon A and senofilcon C lenses after one month of wear.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Performance Comparison Between Comfilcon A and Senofilcon C Lenses
Study Start Date : September 2016
Actual Primary Completion Date : November 23, 2016
Actual Study Completion Date : November 23, 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: comfilcon A
Participants are randomized to wear the comfilcon A lens for one month during the cross over study.
 Device: comfilcon A
contact lens
Active Comparator: senofilcon C
Participants are randomized to wear the senofilcon C lens for one month during the cross over study.
 Device: senofilcon C
contact lens


Outcome Measures
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Primary Outcome Measures :
  1. Overall Lens Fit Acceptance [ Time Frame: Up to 1 month ]
    Investigator fit acceptability for comfilcon A and senofilcon C lenses. Scale 0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect.

  2. Corneal Coverage [ Time Frame: Up to 1 month ]
    Corneal coverage for comfilcon A and senofilcon C lenses. (yes/no)

  3. Lens Centration [ Time Frame: Up to 1 month ]
    Lens centration for comfilcon A and senofilcon C lenses. (optimum/ decentration acceptable/ decentration unacceptable)

  4. Post-blink Movement [ Time Frame: Up to 1 month ]
    Post-blink movement for comfilcon A and senofilcon C lenses. Scale 0-4, (1 step size) (0=Insufficient, 4=Excessive, unacceptable movement)

  5. Lens Lag at Primary Gaze [ Time Frame: Up to 1 month ]
    Lens lag at primary gaze for comfilcon A and senofilcon C lenses. (mm, 0.1 step size)

  6. Tightness on Push up [ Time Frame: Up to 1 month ]
    Tightness on push up for comfilcon A and senofilcon C lenses. Scale 0%-100%, 0%=falls from cornea, 50%=optimum, 100%=no movement)

  7. Lens Wettability [ Time Frame: Up to 1 month ]
    Lens wettability for comfilcon A and senofilcon C lenses. Scale 0-4, (0.5 step size) (0=very poor, 4=excellent)

  8. Deposit Grading [ Time Frame: Up to 1 month ]
    Deposit grading for comfilcon A and senofilcon C lenses. Scale 0-4 (0.5 step size) (0=no deposits, 4=severe deposits)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 34 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

  • Is between 18 and 34 years of age (inclusive)
  • Has had a self-reported eye exam in the last two years
  • Is a spherical soft contact lens wearer
  • Has a contact lens spherical prescription between -1.00 to -6.00 (inclusive)
  • Has a spectacle cylinder no greater than 0.75D (Diopters) in each eye.
  • Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
  • Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
  • Has clear corneas and no active ocular disease
  • Has read, understood and signed the information consent letter.
  • Has a contact lens prescription that fits within the available parameters of the study lenses.
  • Is willing and anticipated to be able to comply with the wear schedule (at least 6 days per week, 12 hours/day assuming there are no contraindications for doing so).
  • Is willing to comply with the visit schedule

Exclusion Criteria:

A person will be excluded from the study if he/she:

  • Has a history of not achieving comfortable CL (contact lens) wear (defined as 6 days per week; > 10 hours/day)
  • Presents with clinically significant anterior segment abnormalities
  • Presents with ocular or systemic disease or need of medications which might interfere with contact lens wear.

  • Presents with slit lamp findings that would contraindicate contact lens wear such as:

    • Pathological dry eye or associated findings
    • Significant pterygium, pinguecula, or corneal scars within the visual axis
    • Neovascularization > 0.75 mm in from of the limbus
    • Giant papillary conjunctivitis (GCP) worse than grade 1
    • Anterior uveitis or iritis (or history in past year)
    • Seborrheic eczema of eyelid region, Seborrheic conjunctivitis
    • History of corneal ulcers or fungal infections
    • Poor personal hygiene
  • Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
  • Has aphakia, keratoconus or a highly irregular cornea.
  • Has presbyopia or has dependence on spectacles for near work over the contact lenses.
  • Has undergone corneal refractive surgery.
  • Is participating in any other type of eye related clinical or research study.
  • Is habitually using rewetting/ lubricating eye drops more than once per day
  • Is currently wearing daily disposable lenses
Contacts and Locations
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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): NCT02920957


Locations
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United States, California
Golden Optometric Group
Whittier, California, United States, 90606
United States, Florida
Coan Eye Care & Optical Boutique
Ocoee, Florida, United States, 34761
United States, Minnesota
Cornea & Contact Lens Institute of Minnesota
Edina, Minnesota, United States, 55436
United States, New York
Sacco Eye Group
Vestal, New York, United States, 13850
United States, Ohio
Vision Professionals
New Albany, Ohio, United States, 43054
Sponsors and Collaborators
Coopervision, Inc.
Investigators
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Study Director: Lyndon Jones, PhD, FAAO, FIACLE, FBCLA Centre for Contact Lens Research
More Information
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Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT02920957    
Other Study ID Numbers: EX-MKTG-70
First Posted: September 30, 2016    Key Record Dates
Results First Posted: January 9, 2018
Last Update Posted: January 9, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases