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Completed

NCT Number: NCT02542072

Multi-Center Clinical Evaluation of Two Reusable Soft Contact Lenses

The purpose of this study is to compare the subjective performance of comfilcon A lens against samfilcon A lens after 4 weeks of reusable lens wear.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brock & Houlford, Chew Magna, Bristol, United Kingdom

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About this study

This will be a 90 subject, randomized, bilateral, subject-masked, dispensing, cross-over study comparing comfilcon A versus samfilcon A lenses over 8 weeks of daily wear (2 x 4-weeks). Both eyes will wear the same lens (test or control) for 4 weeks in a randomized fashion. Subjects will be masked to lens type and investigators will be masked to the lens codes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion:

  • Spherical distance Contact Lens prescription between -1.00 and -6.00D or +1.00 to +4.00D in both eyes (inclusive)
  • Adapted soft Contact Lens wearers (i.e. >1 month), daily disposable and reusable lens wearers.
  • Spectacle cylinder 0.75D in both eyes.
  • Correctable to 6/9 (20/30) in both eyes
  • Be between 18 and 50 years of age (inclusive)
  • Able to read, comprehend and sign an informed consent
  • Own a mobile phone and be willing to respond to Short Message Service (SMS) survey
  • Willing to comply with the wear and study visit schedule

Exclusion:

  • Existing Biofinity or Ultra wearers
  • Any active corneal infection, injury or inflammation
  • Systemic or ocular allergies, which might interfere with Contact Lens wear
  • Systemic disease, which might interfere with Contact Lens wear
  • Ocular disease, which might interfere with Contact Lens wear
  • Strabismus or amblyopia
  • Subjects who have undergone corneal refractive surgery
  • Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear
  • Pregnant or lactating
  • Use of systemic/topical medication contraindicating Contact Lens wear
  • Diabetic
  • Site employees or family members of site employees

Treatment and study plan

comfilcon A

Device

contact lens

samfilcon A

Device

contact lens

Primary outcomes

  1. Comfort

    Time frame: Baseline, 2 weeks, 4 weeks

    Subjective ratings of comfort (comfort after insertion, typical comfort just prior to removal, and overall comfort) for comfilcon A and samfilcon A assessed at baseline, 2 weeks, and 4 weeks. Scale of 0-10 (0=painful, 10=can't feel the lenses).

Secondary outcomes

  1. Comfortable Wearing Time Via SMS (Short Message Service)

    Time frame: Days 3, 12, 26

    Comfortable wearing times (WTs) via SMS (Short Message Service) for comfilcon A and samfilcon A lenses assessed at days 3, 12, and 26 at hours 8:00 am, 12:00 pm, 4:00 pm, and 8:00 pm. Scale of 0-10 (0=painful, 10=can't feel the lenses).

  2. Wearing Times

    Time frame: Baseline, 2 weeks, 4 weeks

    Average wear time and comfortable wearing times (WTs) in hours for habitual, comfilcon A, and samfilcon A lenses.

  3. Deterioration in Comfort

    Time frame: Baseline, 2 weeks, 4 weeks

    Deterioration of comfortable wearing time for habitual, comfilcon A, samfilcon A lenses. Subjects answered 'yes' or 'no' to the following question 'does contact lens comfort deteriorate during wear?'. Yes=deterioration in comfort present, No=deterioration in comfort absent

  4. Vision Quality

    Time frame: Baseline, 2 weeks, 4 weeks

    Vision quality of comfilcon A and samfilcon A lenses. Scale 0-10, 0=completely dissatisfied, 10=completely satisfied.

  5. Overall Lens Handling

    Time frame: Baseline, 2 weeks, 4 weeks

    Handling (ease of insertion and ease of removal) for comfilcon A and samfilcon A lenses. Scale 0-10, 0=very difficult to handle, 10=very easy to handle.

  6. Biomicroscopy Scores

    Time frame: Baseline, 2 weeks, 4 weeks

    Biomicroscopy for comfilcon A and samfilcon A lens assessed. Scale 0-4 in 0.5 steps 0=none, 1=trace, 2=mild, 3=moderate, 4=severe

  7. Lens Surface Wetting

    Time frame: Baseline, 2 weeks, 4 weeks

    Lens surface wettability assessment for comfilcon A and samfilcon A lenses. Scale 0-4 in 0.5 steps, 0=very poor, 4=excellent

  8. Film Deposits

    Time frame: 2 weeks and 4 weeks

    Front surface film deposits for comfilcon A and samfilcon A lenses. Scale 0-4, 0=No film, 1=Slight film visible only under magnification, 2=Moderate film only under magnification, 3=Moderate film visible to the naked eye, 4=Heavy film visible to the naked eye.

  9. White Spot Deposits

    Time frame: 2 weeks and 4 weeks

    Number of white spot deposits for comfilcon A and samfilcon A lenses.

  10. Visual Acuity (VA)

    Time frame: Baseline, 2 weeks, 4 weeks

    Visual acuity (VA) for comfilcon A and samfilcon A lens wear is assessed using Snellen.

  11. Lens Centration

    Time frame: Baseline, 2 weeks, 4 weeks

    Lens centration will be recorded by degree and direction in the primary position. 0=Centered -optimal, 1=Decentered slightly, 2=Substantially decentered (>0.5mm)

  12. Corneal Coverage

    Time frame: Baseline Visit, 2 weeks follow-up, 4-weeks follow-up

    Investigator assessment of corneal coverage for comfilcon A and samfilcon A lenes.

    Yes = coverage at all times or No = coverage incomplete

  13. Post-Blink Movement

    Time frame: Baseline, 2 weeks, 4 weeks

    Post-blink movement for comifilcon A and samfilcon A lenses are assessed. 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement

  14. Primary Gaze Lag

    Time frame: Baseline, 2 weeks, and 4 weeks

    Investigator assessment of primary gaze lag for comfilcon A and samfilcon A lenses. Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement

  15. Lens Tightness Push-up

    Time frame: Baseline, 2 weeks, 4 weeks

    Investigator assessment of lens tightness push-up for comfilcon A and samfilcon A lenses.

    Scale 0%-100% continuous scale, 100%=No movement, 50%=Optimum, 0%=Falls from cornea without lid support

  16. Overall Fit Acceptance

    Time frame: Baseline, 2 weeks, 4 weeks

    Overall fit acceptance for comfilcon A and samfilcon A lenses. Scale 0-4, 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimum acceptable, early review, 3=Not perfect but okay to dispense, 4=Perfect

  17. Dryness

    Time frame: Baseline, 2 weeks, 4 weeks

    Subjective response of dryness for comfilcon A and samfilcon A lenses during a typical day of wear and prior to removal. Scale of 0-10, 10=No dryness, 0=Extremely dry

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 4, 2015
Registry last updated
Oct 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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