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OpenTrials
Completed

NCT Number: NCT02956460

Performance Comparison Between Fanfilcon A and Senofilcon A Sphere Lenses

Prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, 1 month dispensing study (2 weeks each lens pair)

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eric M. White O. D., Inc, San Diego, California, United States

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About this study

The aim of this study is to determine the clinical performance of fanfilcon A in comparison to senofilcon A sphere contact lenses.

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 40 years of age (inclusive)
  • Has read, understood and signed the information consent letter
  • Has had a self-reported eye exam in the last two years
  • Is a spherical soft contact lens wearer
  • Has a contact lens prescription that fits within the available parameters of the study lenses
  • 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
  • Is willing and anticipated to be able to comply with the wear schedule (8 hours per day; 5 days a week of lens wear)
  • Is willing and able to follow instructions and maintain the appointment 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 5 days per week; >8 hours/day)
  • Is currently wearing senofilcon C (2 weeks lens), senofilcon A 1-Day, senofilcon C (monthly lens) or enfilcon A contact lenses
  • Is habitually using rewetting/ lubricating eye drops more than once per 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

Treatment and study plan

fanfilcon A

Device

contact lens

Senofilcon A

Device

contact lens

Primary outcomes

  1. Overall Comfort

    Time frame: 2 weeks

    Subjective assessment for comfort is assessed. Scale 0-10, 0=painful, 10=can't feel

  2. Overall Dryness

    Time frame: 2 weeks

    Subjective ratings for dryness is assessed on a scale of 0-10, 0=extremely dry, 10=no dryness

  3. Vision Quality

    Time frame: 2 weeks

    Subjective ratings of vision quality is assessed on a scale 0-10, 0=not sharp/not clear, 10=sharp/clear

  4. Lens Handling

    Time frame: 2 weeks

    Subjective ratings of lens handling - insertion and removal - is assessed using scale 0-10, 0=difficult to handle, 10=very easy to handle

  5. Vision Satisfaction

    Time frame: 2 weeks

    Subjective ratings of vision satisfaction is assessed on a scale 0-10, 0=completely dissatisfied, 10=completely satisfied.

  6. Lens Centration

    Time frame: 2 weeks

    Lens centration will be recorded by degree and direction in the primary position. (Optimum, decentration acceptable, decentration unacceptable).

  7. Conjunctival Staining

    Time frame: 2 weeks

    Assessed using slit lamp with blue light and sodium fluorescein, low medium magnification.

    0=None, no staining present

    • Very slight
    • Slight
    • Moderate
    • Severe

  8. Smoothness

    Time frame: 2 weeks

    Subjective ratings for lens sensation of smoothness is assessed on a scale 0-10, 0=not smooth at all, 10=totally smooth

  9. Clean Feeling

    Time frame: 2 weeks

    Subjective ratings for lens clean feeling is assessed on a scale 0-10, 0=not clean at all, 10=lenses feel perfectly clean

  10. Lens Hydrated

    Time frame: 2 weeks

    Subjective ratings for lens sensation is assessed on a scale 0-10, 0=totally dehydrated, 10=totally hydrated

  11. Lens Wettability

    Time frame: 2 weeks

    Subjective ratings for lens wettability is assessed on a scale 0-10, 0=non-wettable, 10=highly wettable

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Nov 7, 2016
Registry last updated
Apr 2, 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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