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Refitting Somofilcon A Sphere Contact Lens Wearers Into Fanfilcon A Sphere Lenses for 4-Weeks of Wear

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
somofilcon A contact lens
fanfilcon A contact lens
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 SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Is between 18 and 40 years of age (inclusive)
  • Has had a self-reported visual exam in the last two years
  • Is an adapted soft contact lens wearer
  • Has a contact lens spherical prescription between - 0.25 to - 8.00 (inclusive)
  • Have no less than -0.75D of astigmatism in both eyes.
  • 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:

  • Has a CL prescription outside the range of the available parameters of the study lenses.
  • Has a spectacle cylinder of ≥ 1.00D 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 2-4) 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 Clinic, National Autonomous University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

somofilcon A (habitual) lens, then fanfilcon A (test) lens

Arm Description

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

Outcomes

Primary Outcome Measures

Lens Centration for Somofilcon A (Habitual) Lens
Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Lens Centration for Somofilcon A (Habitual) Lens
Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Lens Centration for Fanfilcon A (Test) Lens
Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Lens Centration for Fanfilcon A (Test) Lens
Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Lens Centration for Fanfilcon A (Test) Lens
Lens Centration was measured using a 3-point scale(1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Lens Corneal Coverage for Somofilcon A (Habitual) Lens
Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Lens Corneal Coverage for Somofilcon A (Habitual) Lens
Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Lens Corneal Coverage for Fanfilcon A (Test) Lens
Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Lens Corneal Coverage for Fanfilcon A (Test) Lens
Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Lens Corneal Coverage for Fanfilcon A (Test) Lens
Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Percentage of Lens Tightness for Somofilcon A (Habitual) Lens
Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)
Percentage of Lens Tightness for Somofilcon A (Habitual) Lens
Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)
Percentage of Lens Tightness for Fanfilcon A (Test) Lens
Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)
Percentage of Lens Tightness for Fanfilcon A (Test) Lens
Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)
Percentage of Lens Tightness for Fanfilcon A (Test) Lens
Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)
Post-Blink Movement for Somofilcon A (Habitual) Lens
Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)
Post-Blink Movement for Somofilcon A (Habitual) Lens
Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)
Post-Blink Movement for Fanfilcon A (Test) Lens
Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)
Post-Blink Movement for Fanfilcon A (Test) Lens
Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)
Post-Blink Movement for Fanfilcon A (Test) Lens
Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)
Overall Lens Fit Acceptance for Somofilcon A (Habitual) Lens
Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect)
Overall Lens Fit Acceptance for Somofilcon A (Habitual) Lens
Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect)
Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens
Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect)
Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens
Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect)
Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens
Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect)

Secondary Outcome Measures

Average Daily Wearing Time - Somofilcon A (Habitual) Lens
Average Daily Wearing Time for somofilcon A (Habitual) lens - measured by time hours/day
Average Daily Wearing Time - Fanfilcon A (Test) Lens
Average daily wearing time for fanfilcon A (test) lens was measured in hours/day
Average Daily Wearing Time - Fanfilcon A (Test) Lens
Average daily wearing time for fanfilcon A (test) lens was measured in hours/day
Average Comfortable Wearing Time - Somofilcon A (Habitual) Lens
Average Comfortable Wearing Time - somofilcon A (habitual) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation.
Average Comfortable Wearing Time - Fanfilcon A (Test) Lens
Average Comfortable Wearing Time - fanfilcon A (test) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation.
Average Comfortable Wearing Time - Fanfilcon A (Test) Lens
Average Comfortable Wearing Time - fanfilcon A (test) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation.

Full Information

First Posted
June 3, 2019
Last Updated
August 6, 2020
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03974802
Brief Title
Refitting Somofilcon A Sphere Contact Lens Wearers Into Fanfilcon A Sphere Lenses for 4-Weeks of Wear
Official Title
Refitting Somofilcon A Sphere Contact Lens Wearers Into Fanfilcon A Sphere Lenses for 4-Weeks of Wear
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
May 14, 2019 (Actual)
Primary Completion Date
July 24, 2019 (Actual)
Study Completion Date
August 28, 2019 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this subject-masked prospective study is to evaluate the clinical performance of habitual wearers of Clariti Elite sphere lenses after a refit with Avaira Vitality sphere lenses.
Detailed Description
The aim of this subject-masked prospective study is to evaluate the clinical performance of habitual wearers of Clariti Elite sphere lenses after a refit with Avaira Vitality sphere lenses for 4 weeks of daily wear.

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
Model Description
First pair of study lenses (habitual lenses) will be dispensed and worn for 4 weeks for daily wear, then second pair of lenses (test lenses) will be dispensed and worn for 4 weeks for daily wear.
Masking
None (Open Label)
Masking Description
Study lenses will be transferred, by an assistant, out of their packaging to unmarked new contact lens cases filled with unpreserved sterile saline just prior to dispensing to maintain subject masking of the study lenses.
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
somofilcon A (habitual) lens, then fanfilcon A (test) lens
Arm Type
Experimental
Arm Description
Participants are habitual wearers of somofilcon A lens and refitted with fanfilcon A lens.
Intervention Type
Device
Intervention Name(s)
somofilcon A contact lens
Other Intervention Name(s)
clariti elite, Habitual lens
Intervention Description
Contact Lens
Intervention Type
Device
Intervention Name(s)
fanfilcon A contact lens
Other Intervention Name(s)
Avaira Vitality, Test lens
Intervention Description
Contact Lens
Primary Outcome Measure Information:
Title
Lens Centration for Somofilcon A (Habitual) Lens
Description
Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time Frame
Baseline
Title
Lens Centration for Somofilcon A (Habitual) Lens
Description
Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time Frame
4- weeks
Title
Lens Centration for Fanfilcon A (Test) Lens
Description
Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time Frame
Baseline
Title
Lens Centration for Fanfilcon A (Test) Lens
Description
Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time Frame
2-weeks
Title
Lens Centration for Fanfilcon A (Test) Lens
Description
Lens Centration was measured using a 3-point scale(1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time Frame
4- weeks
Title
Lens Corneal Coverage for Somofilcon A (Habitual) Lens
Description
Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Time Frame
Baseline
Title
Lens Corneal Coverage for Somofilcon A (Habitual) Lens
Description
Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Time Frame
4 -weeks
Title
Lens Corneal Coverage for Fanfilcon A (Test) Lens
Description
Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Time Frame
Baseline
Title
Lens Corneal Coverage for Fanfilcon A (Test) Lens
Description
Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Time Frame
2-weeks
Title
Lens Corneal Coverage for Fanfilcon A (Test) Lens
Description
Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Time Frame
4-weeks
Title
Percentage of Lens Tightness for Somofilcon A (Habitual) Lens
Description
Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)
Time Frame
Baseline
Title
Percentage of Lens Tightness for Somofilcon A (Habitual) Lens
Description
Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)
Time Frame
4-Weeks
Title
Percentage of Lens Tightness for Fanfilcon A (Test) Lens
Description
Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)
Time Frame
Baseline
Title
Percentage of Lens Tightness for Fanfilcon A (Test) Lens
Description
Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)
Time Frame
2-Weeks
Title
Percentage of Lens Tightness for Fanfilcon A (Test) Lens
Description
Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)
Time Frame
4-Weeks
Title
Post-Blink Movement for Somofilcon A (Habitual) Lens
Description
Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)
Time Frame
Baseline
Title
Post-Blink Movement for Somofilcon A (Habitual) Lens
Description
Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)
Time Frame
4-weeks
Title
Post-Blink Movement for Fanfilcon A (Test) Lens
Description
Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)
Time Frame
Baseline
Title
Post-Blink Movement for Fanfilcon A (Test) Lens
Description
Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)
Time Frame
2-weeks
Title
Post-Blink Movement for Fanfilcon A (Test) Lens
Description
Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)
Time Frame
4-weeks
Title
Overall Lens Fit Acceptance for Somofilcon A (Habitual) Lens
Description
Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect)
Time Frame
Baseline
Title
Overall Lens Fit Acceptance for Somofilcon A (Habitual) Lens
Description
Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect)
Time Frame
4-weeks
Title
Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens
Description
Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect)
Time Frame
Baseline
Title
Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens
Description
Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect)
Time Frame
2-weeks
Title
Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens
Description
Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect)
Time Frame
4-weeks
Secondary Outcome Measure Information:
Title
Average Daily Wearing Time - Somofilcon A (Habitual) Lens
Description
Average Daily Wearing Time for somofilcon A (Habitual) lens - measured by time hours/day
Time Frame
4-weeks
Title
Average Daily Wearing Time - Fanfilcon A (Test) Lens
Description
Average daily wearing time for fanfilcon A (test) lens was measured in hours/day
Time Frame
2-weeks
Title
Average Daily Wearing Time - Fanfilcon A (Test) Lens
Description
Average daily wearing time for fanfilcon A (test) lens was measured in hours/day
Time Frame
4-weeks
Title
Average Comfortable Wearing Time - Somofilcon A (Habitual) Lens
Description
Average Comfortable Wearing Time - somofilcon A (habitual) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation.
Time Frame
4 weeks
Title
Average Comfortable Wearing Time - Fanfilcon A (Test) Lens
Description
Average Comfortable Wearing Time - fanfilcon A (test) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation.
Time Frame
2 weeks
Title
Average Comfortable Wearing Time - Fanfilcon A (Test) Lens
Description
Average Comfortable Wearing Time - fanfilcon A (test) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Is between 18 and 40 years of age (inclusive) Has had a self-reported visual exam in the last two years Is an adapted soft contact lens wearer Has a contact lens spherical prescription between - 0.25 to - 8.00 (inclusive) Have no less than -0.75D of astigmatism in both eyes. 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: Has a CL prescription outside the range of the available parameters of the study lenses. Has a spectacle cylinder of ≥ 1.00D 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 2-4) 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
Ruben Velázquez Guerrero, MSc., FIACLE
Organizational Affiliation
School of Optometry, National Autonomous University (UNAM), Mexico City
Official's Role
Principal Investigator
Facility Information:
Facility Name
Optometry Clinic, National Autonomous University
City
Mexico City
ZIP/Postal Code
54090
Country
Mexico

12. IPD Sharing Statement

Learn more about this trial

Refitting Somofilcon A Sphere Contact Lens Wearers Into Fanfilcon A Sphere Lenses for 4-Weeks of Wear

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