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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.

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

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Performance Comparison Between Fanfilcon A and Senofilcon A Sphere Lenses
Actual Study Start Date : October 27, 2016
Actual Primary Completion Date : December 14, 2016
Actual Study Completion Date : December 14, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: fanfilcon A
Participants are randomized to wear fanfilcon A for two weeks during the cross over study.
Device: fanfilcon A
contact lens

Active Comparator: senofilcon A
Participants are randomized to wear senofilcon A for two weeks during the cross over study.
Device: senofilcon A
contact lens




Primary Outcome Measures :
  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

    1. Very slight
    2. Slight
    3. Moderate
    4. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 40 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 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

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): NCT02956460


Locations
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United States, California
Eric M. White O. D., Inc
San Diego, California, United States, 92123
United States, Florida
Golden Vision
Sarasota, Florida, United States, 34232
United States, Kansas
Kannarr Eye Care
Pittsburg, Kansas, United States, 66762
United States, Pennsylvania
Nittany Eye Associates
State College, Pennsylvania, United States, 16801
Sponsors and Collaborators
Coopervision, Inc.
Investigators
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Study Director: Lyndon Jones, PhD, FAAO Centre for Contact Lens Research

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Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT02956460     History of Changes
Other Study ID Numbers: EX-MKTG-73
First Posted: November 7, 2016    Key Record Dates
Results First Posted: December 8, 2017
Last Update Posted: April 2, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases