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Performance Comparison Between Fanfilcon A and Senofilcon A Sphere Lenses

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ClinicalTrials.gov Identifier: NCT02956460
Recruitment Status : Completed
First Posted : November 7, 2016
Results First Posted : December 8, 2017
Last Update Posted : April 2, 2018
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.

Tracking Information
First Submitted Date  ICMJE November 3, 2016
First Posted Date  ICMJE November 7, 2016
Results First Submitted Date  ICMJE November 10, 2017
Results First Posted Date  ICMJE December 8, 2017
Last Update Posted Date April 2, 2018
Actual Study Start Date  ICMJE October 27, 2016
Actual Primary Completion Date December 14, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 10, 2017)
  • Overall Comfort [ Time Frame: 2 weeks ]
    Subjective assessment for comfort is assessed. Scale 0-10, 0=painful, 10=can't feel
  • Overall Dryness [ Time Frame: 2 weeks ]
    Subjective ratings for dryness is assessed on a scale of 0-10, 0=extremely dry, 10=no dryness
  • 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
  • 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
  • Vision Satisfaction [ Time Frame: 2 weeks ]
    Subjective ratings of vision satisfaction is assessed on a scale 0-10, 0=completely dissatisfied, 10=completely satisfied.
  • Lens Centration [ Time Frame: 2 weeks ]
    Lens centration will be recorded by degree and direction in the primary position. (Optimum, decentration acceptable, decentration unacceptable).
  • Conjunctival Staining [ Time Frame: 2 weeks ]
    Assessed using slit lamp with blue light and sodium fluorescein, low medium magnification. 0=None, no staining present
    1. Very slight
    2. Slight
    3. Moderate
    4. Severe
  • 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
  • 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
  • Lens Hydrated [ Time Frame: 2 weeks ]
    Subjective ratings for lens sensation is assessed on a scale 0-10, 0=totally dehydrated, 10=totally hydrated
  • Lens Wettability [ Time Frame: 2 weeks ]
    Subjective ratings for lens wettability is assessed on a scale 0-10, 0=non-wettable, 10=highly wettable
Original Primary Outcome Measures  ICMJE
 (submitted: November 3, 2016)
  • Comfort [ Time Frame: Up to 2 weeks ]
    Subjective assessment for comfort is assessed. Scale 0-10, 0=painful, 10=can't feel
  • Dryness [ Time Frame: Up to 2 weeks ]
    Subjective ratings for dryness is assessed on a scale of 0-10, 0=extremely dry, 10=no dryness
  • Vision Quality [ Time Frame: Up to 2 weeks ]
    Subjective ratings of vision quality is assessed on a scale 0-10, 0=not sharp/not clear, 10=sharp/clear
  • Lens Handling [ Time Frame: Up to 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
  • Vision Satisfaction [ Time Frame: Up to 2 weeks ]
    Subjective ratings of vision satisfaction is assessed on a scale 0-10, 0=completely dissatisfied, 10=completely satisfied.
  • Lens Centration [ Time Frame: Up to 2 weeks ]
    Lens centration will be recorded by degree and direction in the primary position. (Optimum, decentration acceptable, decentration unacceptable).
  • Conjunctival Staining [ Time Frame: Up to 2 weeks ]
    Assessed using slit lamp with blue light and sodium fluorescein, low medium magnification. 0=None, no staining present
    1. Very slight
    2. Slight
    3. Moderate
    4. Severe
  • Smoothness [ Time Frame: Up to 2 weeks ]
    Subjective ratings for lens sensation of smoothness is assessed on a scale 0-10, 0=not smooth at all, 10=totally smooth
  • Clean Feeling [ Time Frame: Up to 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
  • Lens Hydrated [ Time Frame: Up to 2 weeks ]
    Subjective ratings for lens sensation is assessed on a scale 0-10, 0=totally dehydrated, 10=totally hydrated
  • Lens Wettability [ Time Frame: Up to 2 weeks ]
    Subjective ratings for lens wettability is assessed on a scale 0-10, 0=non-wettable, 10=highly wettable
Change History Complete list of historical versions of study NCT02956460 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Performance Comparison Between Fanfilcon A and Senofilcon A Sphere Lenses
Official Title  ICMJE Performance Comparison Between Fanfilcon A and Senofilcon A Sphere Lenses
Brief Summary Prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, 1 month dispensing study (2 weeks each lens pair)
Detailed Description The aim of this study is to determine the clinical performance of fanfilcon A in comparison to senofilcon A sphere contact lenses.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Myopia
Intervention  ICMJE
  • Device: fanfilcon A
    contact lens
  • Device: senofilcon A
    contact lens
Study Arms  ICMJE
  • Active Comparator: fanfilcon A
    Participants are randomized to wear fanfilcon A for two weeks during the cross over study.
    Intervention: Device: fanfilcon A
  • Active Comparator: senofilcon A
    Participants are randomized to wear senofilcon A for two weeks during the cross over study.
    Intervention: Device: senofilcon A
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 3, 2016)
64
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 14, 2016
Actual Primary Completion Date December 14, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02956460
Other Study ID Numbers  ICMJE EX-MKTG-73
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Coopervision, Inc.
Study Sponsor  ICMJE Coopervision, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Lyndon Jones, PhD, FAAO Centre for Contact Lens Research
PRS Account Coopervision, Inc.
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP