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Completed

NCT Number: NCT02920957

Performance Comparison Between Comfilcon A and Senofilcon C Lenses

The aim of this study is to determine the clinical performance of comfilcon A in comparison to senofilcon C.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year–34 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Golden Optometric Group, Whittier, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

comfilcon A

Device

contact lens

senofilcon C

Device

contact lens

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 30, 2016
Registry last updated
Jan 9, 2018

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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