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Performance of Aspheric Hydrogel Lenses After a Refit With Sphere Silicone Hydrogel Lenses for 4 Weeks

Primary Purpose

Ametropia

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
methafilcon A contact lenses
fanfilcon A contact lenses
Sponsored by
Coopervision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Ametropia

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 (Diopter) 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 Contact Lens (CL) prescription outside the range of the available parameters of the study lenses
  • Has a spectacle cylinder of ≥ 1.00D (Diopter) in either eye
  • Has a history of not achieving comfortable Contact Lens (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

Sites / Locations

  • Optometry Clinic, National Autonomous University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

methalfilcon A contact lenses / fanfilcon A contact lenses

Arm Description

All subjects will first wear methafilcon A contact lenses for four (4) weeks of daily wear, then be refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear.

Outcomes

Primary Outcome Measures

Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses
Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses
Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses
Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses
Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses
Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Contact Lenses
Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Contact Lenses
Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses
Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses
Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses
Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Post-blink Movement Assessment by the Investigator - Methafilcon A Contact Lenses
Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Post-blink Movement Assessment by the Investigator - Methafilcon A Contact Lenses
Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses
Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses
Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses
Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Lens Tightness Assessment by the Investigator - Methafilcon A Contact Lenses
Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).
Lens Tightness Assessment by the Investigator - Methafilcon A Contact Lenses
Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).
Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses
Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).
Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses
Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).
Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses
Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).
Overall Lens Fit Acceptance by the Investigator - Methafilcon A Contact Lenses
Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect
Overall Lens Fit Acceptance by the Investigator - Methafilcon A Contact Lenses
Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect
Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses
Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect
Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses
Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect
Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses
Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect

Secondary Outcome Measures

Average Daily Wearing Time - Methafilcon A Contact Lenses
Average daily wearing time response by the subject
Average Daily Wearing Time - Fanfilcon A Contact Lenses
Average daily wearing time response by the subject.
Average Daily Wearing Time - Fanfilcon A Contact Lenses
Average daily wearing time response by the subject
Average Comfortable Wearing Time - Methafilcon A Contact Lenses
Average comfortable wearing time - response by the subject
Average Comfortable Wearing Time - Fanfilcon A Contact Lenses
Average comfortable wearing time - response by the subject
Average Comfortable Wearing Time - Fanfilcon A Contact Lenses
Average comfortable wearing time - response by the subject

Full Information

First Posted
January 31, 2019
Last Updated
May 29, 2020
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03835078
Brief Title
Performance of Aspheric Hydrogel Lenses After a Refit With Sphere Silicone Hydrogel Lenses for 4 Weeks
Official Title
Performance of Aspheric Hydrogel Lenses After a Refit With Sphere Silicone Hydrogel Lenses for 4 Weeks
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
March 27, 2019 (Actual)
Study Completion Date
July 6, 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 prospective study is to evaluate the clinical performance of habitual wearers of methafilcon A aspheric lenses after a refit with fanfilcon A 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
Ametropia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
methalfilcon A contact lenses / fanfilcon A contact lenses
Arm Type
Experimental
Arm Description
All subjects will first wear methafilcon A contact lenses for four (4) weeks of daily wear, then be refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear.
Intervention Type
Device
Intervention Name(s)
methafilcon A contact lenses
Intervention Description
Bilateral daily wear of methafilcon A contact lenses
Intervention Type
Device
Intervention Name(s)
fanfilcon A contact lenses
Intervention Description
Bilateral daily wear of fanfilcon A contact lenses
Primary Outcome Measure Information:
Title
Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses
Description
Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time Frame
Baseline
Title
Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses
Description
Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time Frame
4 weeks
Title
Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses
Description
Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time Frame
Baseline
Title
Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses
Description
Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time Frame
2 weeks
Title
Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses
Description
Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time Frame
4 weeks
Title
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Contact Lenses
Description
Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Time Frame
Baseline
Title
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Contact Lenses
Description
Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Time Frame
4 weeks
Title
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses
Description
Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Time Frame
Baseline
Title
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses
Description
Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Time Frame
2 weeks
Title
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses
Description
Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Time Frame
4 weeks
Title
Post-blink Movement Assessment by the Investigator - Methafilcon A Contact Lenses
Description
Post-blink movement, was rated at each visit using a 0-4 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
Title
Post-blink Movement Assessment by the Investigator - Methafilcon A Contact Lenses
Description
Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Time Frame
4 weeks
Title
Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses
Description
Post-blink movement, was rated at each visit using a 0-4 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
Title
Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses
Description
Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Time Frame
2 weeks
Title
Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses
Description
Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Time Frame
4 weeks
Title
Lens Tightness Assessment by the Investigator - Methafilcon A Contact Lenses
Description
Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).
Time Frame
Baseline
Title
Lens Tightness Assessment by the Investigator - Methafilcon A Contact Lenses
Description
Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).
Time Frame
4 weeks
Title
Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses
Description
Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).
Time Frame
Baseline
Title
Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses
Description
Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).
Time Frame
2 weeks
Title
Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses
Description
Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).
Time Frame
4 weeks
Title
Overall Lens Fit Acceptance by the Investigator - Methafilcon A Contact Lenses
Description
Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect
Time Frame
Baseline
Title
Overall Lens Fit Acceptance by the Investigator - Methafilcon A Contact Lenses
Description
Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect
Time Frame
4 weeks
Title
Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses
Description
Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect
Time Frame
Baseline
Title
Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses
Description
Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect
Time Frame
2 weeks
Title
Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses
Description
Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Average Daily Wearing Time - Methafilcon A Contact Lenses
Description
Average daily wearing time response by the subject
Time Frame
4 weeks
Title
Average Daily Wearing Time - Fanfilcon A Contact Lenses
Description
Average daily wearing time response by the subject.
Time Frame
2 weeks
Title
Average Daily Wearing Time - Fanfilcon A Contact Lenses
Description
Average daily wearing time response by the subject
Time Frame
4 weeks
Title
Average Comfortable Wearing Time - Methafilcon A Contact Lenses
Description
Average comfortable wearing time - response by the subject
Time Frame
4 weeks
Title
Average Comfortable Wearing Time - Fanfilcon A Contact Lenses
Description
Average comfortable wearing time - response by the subject
Time Frame
2 weeks
Title
Average Comfortable Wearing Time - Fanfilcon A Contact Lenses
Description
Average comfortable wearing time - response by the subject
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 (Diopter) 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 Contact Lens (CL) prescription outside the range of the available parameters of the study lenses Has a spectacle cylinder of ≥ 1.00D (Diopter) in either eye Has a history of not achieving comfortable Contact Lens (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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruben Velazquez, MSc FIACLE
Organizational Affiliation
School of Optometry, National Autonomous University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Optometry Clinic, National Autonomous University
City
Mexico City
Country
Mexico

12. IPD Sharing Statement

Learn more about this trial

Performance of Aspheric Hydrogel Lenses After a Refit With Sphere Silicone Hydrogel Lenses for 4 Weeks

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