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Performance Comparison Between Fanfilcon A and Senofilcon A Sphere Lenses

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
fanfilcon A
senofilcon A
Sponsored by
Coopervision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Eric M. White O. D., Inc
  • Golden Vision
  • Kannarr Eye Care
  • Nittany Eye Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

fanfilcon A

senofilcon A

Arm Description

Participants are randomized to wear fanfilcon A for two weeks during the cross over study.

Participants are randomized to wear senofilcon A for two weeks during the cross over study.

Outcomes

Primary Outcome Measures

Overall Comfort
Subjective assessment for comfort is assessed. Scale 0-10, 0=painful, 10=can't feel
Overall Dryness
Subjective ratings for dryness is assessed on a scale of 0-10, 0=extremely dry, 10=no dryness
Vision Quality
Subjective ratings of vision quality is assessed on a scale 0-10, 0=not sharp/not clear, 10=sharp/clear
Lens Handling
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
Subjective ratings of vision satisfaction is assessed on a scale 0-10, 0=completely dissatisfied, 10=completely satisfied.
Lens Centration
Lens centration will be recorded by degree and direction in the primary position. (Optimum, decentration acceptable, decentration unacceptable).
Conjunctival Staining
Assessed using slit lamp with blue light and sodium fluorescein, low medium magnification. 0=None, no staining present Very slight Slight Moderate Severe
Smoothness
Subjective ratings for lens sensation of smoothness is assessed on a scale 0-10, 0=not smooth at all, 10=totally smooth
Clean Feeling
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
Subjective ratings for lens sensation is assessed on a scale 0-10, 0=totally dehydrated, 10=totally hydrated
Lens Wettability
Subjective ratings for lens wettability is assessed on a scale 0-10, 0=non-wettable, 10=highly wettable

Secondary Outcome Measures

Full Information

First Posted
November 3, 2016
Last Updated
March 6, 2018
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02956460
Brief Title
Performance Comparison Between Fanfilcon A and Senofilcon A Sphere Lenses
Official Title
Performance Comparison Between Fanfilcon A and Senofilcon A Sphere Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 27, 2016 (Actual)
Primary Completion Date
December 14, 2016 (Actual)
Study Completion Date
December 14, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fanfilcon A
Arm Type
Active Comparator
Arm Description
Participants are randomized to wear fanfilcon A for two weeks during the cross over study.
Arm Title
senofilcon A
Arm Type
Active Comparator
Arm Description
Participants are randomized to wear senofilcon A for two weeks during the cross over study.
Intervention Type
Device
Intervention Name(s)
fanfilcon A
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
senofilcon A
Intervention Description
contact lens
Primary Outcome Measure Information:
Title
Overall Comfort
Description
Subjective assessment for comfort is assessed. Scale 0-10, 0=painful, 10=can't feel
Time Frame
2 weeks
Title
Overall Dryness
Description
Subjective ratings for dryness is assessed on a scale of 0-10, 0=extremely dry, 10=no dryness
Time Frame
2 weeks
Title
Vision Quality
Description
Subjective ratings of vision quality is assessed on a scale 0-10, 0=not sharp/not clear, 10=sharp/clear
Time Frame
2 weeks
Title
Lens Handling
Description
Subjective ratings of lens handling - insertion and removal - is assessed using scale 0-10, 0=difficult to handle, 10=very easy to handle
Time Frame
2 weeks
Title
Vision Satisfaction
Description
Subjective ratings of vision satisfaction is assessed on a scale 0-10, 0=completely dissatisfied, 10=completely satisfied.
Time Frame
2 weeks
Title
Lens Centration
Description
Lens centration will be recorded by degree and direction in the primary position. (Optimum, decentration acceptable, decentration unacceptable).
Time Frame
2 weeks
Title
Conjunctival Staining
Description
Assessed using slit lamp with blue light and sodium fluorescein, low medium magnification. 0=None, no staining present Very slight Slight Moderate Severe
Time Frame
2 weeks
Title
Smoothness
Description
Subjective ratings for lens sensation of smoothness is assessed on a scale 0-10, 0=not smooth at all, 10=totally smooth
Time Frame
2 weeks
Title
Clean Feeling
Description
Subjective ratings for lens clean feeling is assessed on a scale 0-10, 0=not clean at all, 10=lenses feel perfectly clean
Time Frame
2 weeks
Title
Lens Hydrated
Description
Subjective ratings for lens sensation is assessed on a scale 0-10, 0=totally dehydrated, 10=totally hydrated
Time Frame
2 weeks
Title
Lens Wettability
Description
Subjective ratings for lens wettability is assessed on a scale 0-10, 0=non-wettable, 10=highly wettable
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyndon Jones, PhD, FAAO
Organizational Affiliation
Centre for Contact Lens Research
Official's Role
Study Director
Facility Information:
Facility Name
Eric M. White O. D., Inc
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Golden Vision
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
Kannarr Eye Care
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
Nittany Eye Associates
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Performance Comparison Between Fanfilcon A and Senofilcon A Sphere Lenses

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