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Clinical Performance of Existing Wearers of Enfilcon A Following a Refit With Fanfilcon A Lenses for 4 Weeks

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
fanfilcon A (test)
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
  • Has had a self-reported visual exam in the last two years
  • Is an adapted enfilcon A contact lens wearer (at least 2 weeks in enfilcon A lens)
  • Has a contact lens spherical prescription between -1.00 to - 6.00
  • Has a spectacle cylinder up to 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.
  • Patient contact lens refraction should fit within the available parameters of the study lenses.
  • Is willing to comply with the wear schedule (at least 5 days per week, > 8 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:

  • Is not a habitual wearer of enfilcon A lenses
  • Has a CL (Contact Lens) prescription outside the range of the available parameters of the study lenses.
  • Has a spectacle cylinder ≥1.00D of cylinder in either eye.
  • Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
  • Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
  • Presence of clinically significant (grade 3-4) anterior segment abnormalities
  • Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.

  • Slit lamp findings that would contraindicate contact lens wear such as:

    • Pathological dry eye or associated findings
    • 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 (past or present)
    • Seborrheic eczema, 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.

Sites / Locations

  • Optometry Research Group (GIO) Optics Department, University of Valencia

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

enfilcon A (habitual)

fanfilcon A (test)

Arm Description

Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens.

Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens.

Outcomes

Primary Outcome Measures

Lens Fit - Centration
Lens fit evaluation of centration for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale: optimum, decentration acceptable, decentration unacceptable.
Lens Fit - Post-blink Movement
Lens fit evaluation of post-blink movement for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-5 Likert scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement.
Lens Tightness on Push-up
Lens fit evaluation of tightness on push-up test for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale: 0%-100%, 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement.
Overall Fit Acceptance
Overall fit acceptance for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-4, 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimum acceptable, early review, 3=Not perfect but okay to dispense, 4=Perfect.

Secondary Outcome Measures

Overall Comfort
Subjective rating of overall comfort for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=could feel, 10=cannot feel.
Dryness Overall
Subjective rating of overall dryness for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very dry, 10=no dryness.
Handling
Subjective rating of handling for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very difficult to handle, 10=very easy to handle.
Overall Vision Satisfaction
Subjective rating of overall vision satisfaction for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very dissatisfied, 10=very satisfied.
Overall Satisfaction
Subjective rating of overall satisfaction for enfilcon A habitual lens (control) at baseline and fanfilcon A lens (test) at 1 week, 2 weeks, and 4 weeks. Scale 1-4, 1=completely satisfied, 2=somewhat satisfied, 3=somewhat dissatisfied, 4=completely dissatisfied.
Lens Preference Overall
Subject's overall preference for one of two contact lenses. Forced choice: enfilcon A habitual lens (control) or fanfilcon A lens (test).
Wearing Times
Average wearing time and comfortable wearing times for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks measured by hours.
Conjunctival Staining
Conjunctival staining for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. (Scale 0-4, 0.5 steps 0=normal, 4=severe).
Corneal Staining
Corneal staining for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-4, 0.5 steps 0=normal, 4=severe.

Full Information

First Posted
January 28, 2016
Last Updated
July 18, 2017
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02670473
Brief Title
Clinical Performance of Existing Wearers of Enfilcon A Following a Refit With Fanfilcon A Lenses for 4 Weeks
Official Title
Clinical Performance of Existing Wearers of Enfilcon A Following a Refit With Fanfilcon A Lenses for 4 Weeks
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
May 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
The aim of this dispensing study is to evaluate the clinical performance of habitual wearers of enfilcon A lenses following a refit with fanfilcon A lenses over 4 weeks of daily wear.
Detailed Description
This is a 30 subject, prospective, dispensing, bilateral wear, subject-masked study, reviewing the refit characteristics in a group of enfilcon A wearers switched to the fanfilcon A lens. Subject's habitual enfilcon A lenses will be evaluated at the first vist and then re-fitted with a pair of fanfilcon A lenses for 4 weeks of daily wear. After the dispensing visit, subjects will return for evaluations at 1 week, 2 weeks, and 4 weeks.

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
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
enfilcon A (habitual)
Arm Type
No Intervention
Arm Description
Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens.
Arm Title
fanfilcon A (test)
Arm Type
Experimental
Arm Description
Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens.
Intervention Type
Device
Intervention Name(s)
fanfilcon A (test)
Intervention Description
contact lens
Primary Outcome Measure Information:
Title
Lens Fit - Centration
Description
Lens fit evaluation of centration for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale: optimum, decentration acceptable, decentration unacceptable.
Time Frame
Baseline, 1 week, 2 weeks, and 4 weeks
Title
Lens Fit - Post-blink Movement
Description
Lens fit evaluation of post-blink movement for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-5 Likert scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement.
Time Frame
Baseline, 1 week, 2 weeks, and 4 weeks
Title
Lens Tightness on Push-up
Description
Lens fit evaluation of tightness on push-up test for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale: 0%-100%, 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement.
Time Frame
Baseline, 1 week, 2 weeks, and 4 weeks
Title
Overall Fit Acceptance
Description
Overall fit acceptance for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-4, 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimum acceptable, early review, 3=Not perfect but okay to dispense, 4=Perfect.
Time Frame
Baseline, 1 week, 2 weeks, and 4 weeks
Secondary Outcome Measure Information:
Title
Overall Comfort
Description
Subjective rating of overall comfort for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=could feel, 10=cannot feel.
Time Frame
Baseline, 1 week, 2 weeks, and 4 weeks
Title
Dryness Overall
Description
Subjective rating of overall dryness for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very dry, 10=no dryness.
Time Frame
Baseline, 1 week, 2 weeks, and 4 weeks
Title
Handling
Description
Subjective rating of handling for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very difficult to handle, 10=very easy to handle.
Time Frame
Baseline, 1 week, 2 weeks, and 4 weeks
Title
Overall Vision Satisfaction
Description
Subjective rating of overall vision satisfaction for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very dissatisfied, 10=very satisfied.
Time Frame
Baseline, 1 week, 2 weeks, and 4 weeks
Title
Overall Satisfaction
Description
Subjective rating of overall satisfaction for enfilcon A habitual lens (control) at baseline and fanfilcon A lens (test) at 1 week, 2 weeks, and 4 weeks. Scale 1-4, 1=completely satisfied, 2=somewhat satisfied, 3=somewhat dissatisfied, 4=completely dissatisfied.
Time Frame
Baseline, 1 week, 2 weeks, and 4 weeks
Title
Lens Preference Overall
Description
Subject's overall preference for one of two contact lenses. Forced choice: enfilcon A habitual lens (control) or fanfilcon A lens (test).
Time Frame
1 week, 2 weeks, and 4 weeks
Title
Wearing Times
Description
Average wearing time and comfortable wearing times for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks measured by hours.
Time Frame
Baseline, 1 week, 2 weeks, and 4 weeks
Title
Conjunctival Staining
Description
Conjunctival staining for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. (Scale 0-4, 0.5 steps 0=normal, 4=severe).
Time Frame
Baseline, 1 week, 2 weeks, and 4 weeks
Title
Corneal Staining
Description
Corneal staining for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-4, 0.5 steps 0=normal, 4=severe.
Time Frame
Baseline, 1 week, 2 weeks, and 4 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 Has had a self-reported visual exam in the last two years Is an adapted enfilcon A contact lens wearer (at least 2 weeks in enfilcon A lens) Has a contact lens spherical prescription between -1.00 to - 6.00 Has a spectacle cylinder up to 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. Patient contact lens refraction should fit within the available parameters of the study lenses. Is willing to comply with the wear schedule (at least 5 days per week, > 8 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: Is not a habitual wearer of enfilcon A lenses Has a CL (Contact Lens) prescription outside the range of the available parameters of the study lenses. Has a spectacle cylinder ≥1.00D of cylinder in either eye. Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day) Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye. Presence of clinically significant (grade 3-4) anterior segment abnormalities Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear. Slit lamp findings that would contraindicate contact lens wear such as: Pathological dry eye or associated findings 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 (past or present) Seborrheic eczema, 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Montés-Mico, O.D., PhD
Organizational Affiliation
Optometry Research Group (GIO) University of Valencia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Optometry Research Group (GIO) Optics Department, University of Valencia
City
Valencia
ZIP/Postal Code
46100
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Clinical Performance of Existing Wearers of Enfilcon A Following a Refit With Fanfilcon A Lenses for 4 Weeks

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