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Multicenter Dispensing Study of Biofinity Toric Made-To-Order Lenses in Extended Power Ranges

Primary Purpose

Myopia, Astigmatism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
comfilcon A Toric
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 - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Has had an oculo-visual examination in the last two years
  • Is at least 18 years of age and has full legal capacity to volunteer
  • Has read and understood the information consent letter
  • Is willing and able to follow instructions and maintain the appointment schedule
  • Is correctable to a visual acuity of 20/50 or better (in at least one eye)
  • Currently wears soft toric contact lenses in both eyes

  • Subject contact lens prescription must fall under one of the contact lens power ranges for at least one eye:

    • -20.00D to -10.50D spherical powers and cylinder powers from - 0.75 to -2.25
    • +8.50D to +20.00D spherical powers and cylinder powers from - 0.75 to -2.25
    • -20.00D to -6.50D spherical powers and cylinder powers from -2.75 to -5.75
    • -6.00D to +6.00D spherical powers and cylinder powers from -2.75 to -5.75
    • +6.50D to +20.00D spherical powers and cylinder powers from-2.75 to -5.75
  • Has clear corneas and no active ocular disease
  • Demonstrates an acceptable fit with the study lenses

Exclusion Criteria:

  • Has never worn contact lenses before;
  • Has any systemic disease affecting ocular health;
  • Is using any systemic or topical medications that will affect ocular health;
  • Has any ocular pathology or abnormality that would affect the wearing of contact lenses;
  • Has undergone corneal refractive surgery;
  • Is participating in any other type of eye related clinical or research study.

Sites / Locations

  • Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
  • Texas Eye Research and Technology Center (TERTC) College of Optometry, University of Houston

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

comfilcon A toric

Arm Description

Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.

Outcomes

Primary Outcome Measures

Overall Comfort
Subjective ratings for overall comfort for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A lenses assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=cannot be worn, causes pain, and 100=cannot be felt ever.
Overall Vision
Subjective ratings for overall vision for habitual lenses assessed 2 weeks prior to baseline and vision for comfilcon A assessed at baseline and 2 weeks post.Scale 0-100, 0=Extremely poor vision all of the time, cannot function, 100=Excellent vision all of the time.
Handling
Subjective ratings for handling for habitual lenses assessed 2 weeks prior to baseline and handling for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Very difficult, 100=Very easy
Overall Satisfaction
Subjective ratings for overall satisfaction for habitual lenses assessed 2 weeks prior to baseline and overall satisfaction for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Extremely dissatisfied, 100=Extremely satisfied.
Lens Fit - Rotation
Lens Fit (rotation) for habitual lenses were assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A, lens fit rotation was assessed at baseline and 2 weeks. Lens rotation was measured within 10 degrees of the desired 6 o'clock position. Scale 0-180 degrees, 0=no rotation, 180=max rotation.
Lens Fit - Overall Stability
Lens Fit (stability) for habitual lenses assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A lenses, stability was assessed at baseline and 2 weeks. Scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for an astigmatism, 4=Excellent orientation and optimum rotational recovery and stability
Lens Fit Acceptance
General lens fit acceptance for habitual lenses assessed 2 weeks prior to baseline and refitted with comfilcon A lenses, which were assessed at baseline and at 2 weeks. (Scale 0-4, 0=Can't be worn; 4=Optimum)
Anterior Ocular Health - Palpebral Hyperemia and Roughness
Palpebral hyperemia and roughness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None, 4=Severe
Anterior Ocular Health - Bulbar and Limbal Redness
Bulbar and limbal redness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None; 4=Severe injection
Anterior Ocular Health - Corneal Staining
Corneal staining for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=No staining; 4= >45% of area
Anterior Ocular Health - Conjunctival Staining and Indentation
Conjunctival staining and indentation for comfilcon A lenses assessed at baseline and 2 weeks. Conjuctival staining scale 0-4, 0=None, 4=Severe
Visual Acuity
Visual acuity for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A assessed at baseline and 2 weeks post baseline using logMAR.
Subjective Preference - Comfort
Subjective preference for comfort between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses
Preference - Vision
Subjective preference for vision between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses
Preference - Handling
Subjective preference for handling between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses
Overall Preference
Overall subjective preference between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses
Investigator Acceptability
Investigator's preference on acceptability of refitting subjects in to comfilcon A lens based on lens performance assessed at baseline and 2 weeks.Scale 1-5, 1=Strongly agree, 5=Strongly disagree.

Secondary Outcome Measures

Full Information

First Posted
July 15, 2014
Last Updated
July 19, 2020
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02193178
Brief Title
Multicenter Dispensing Study of Biofinity Toric Made-To-Order Lenses in Extended Power Ranges
Official Title
Multicenter Dispensing Study of Biofinity Toric Made-To-Order Lenses in Extended Power Ranges
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 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 study hypothesis is that the Biofinity Toric XR lenses will perform as well as or better than the participants' habitual contact lenses.
Detailed Description
The study hypothesis is that the Biofinity Toric XR lenses will perform as well as or better than the participants' habitual contact lenses. Further, that a minimum of 80% of those enrolled will complete 2 weeks of lens wear with no contraindication to continue.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
comfilcon A toric
Arm Type
Experimental
Arm Description
Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
Intervention Type
Device
Intervention Name(s)
comfilcon A Toric
Other Intervention Name(s)
Biofinity
Intervention Description
Contact lenses
Primary Outcome Measure Information:
Title
Overall Comfort
Description
Subjective ratings for overall comfort for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A lenses assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=cannot be worn, causes pain, and 100=cannot be felt ever.
Time Frame
2 weeks prior to baseline, Baseline, 2 weeks post baseline
Title
Overall Vision
Description
Subjective ratings for overall vision for habitual lenses assessed 2 weeks prior to baseline and vision for comfilcon A assessed at baseline and 2 weeks post.Scale 0-100, 0=Extremely poor vision all of the time, cannot function, 100=Excellent vision all of the time.
Time Frame
2 weeks prior to baseline, Baseline, 2 weeks post
Title
Handling
Description
Subjective ratings for handling for habitual lenses assessed 2 weeks prior to baseline and handling for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Very difficult, 100=Very easy
Time Frame
2 weeks prior to baseline, Baseline, 2 weeks post baseline
Title
Overall Satisfaction
Description
Subjective ratings for overall satisfaction for habitual lenses assessed 2 weeks prior to baseline and overall satisfaction for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Extremely dissatisfied, 100=Extremely satisfied.
Time Frame
2 weeks prior to baseline, Baseline, 2 weeks post baseline
Title
Lens Fit - Rotation
Description
Lens Fit (rotation) for habitual lenses were assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A, lens fit rotation was assessed at baseline and 2 weeks. Lens rotation was measured within 10 degrees of the desired 6 o'clock position. Scale 0-180 degrees, 0=no rotation, 180=max rotation.
Time Frame
2 weeks prior to baseline, Baseline, 2 weeks post baseline
Title
Lens Fit - Overall Stability
Description
Lens Fit (stability) for habitual lenses assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A lenses, stability was assessed at baseline and 2 weeks. Scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for an astigmatism, 4=Excellent orientation and optimum rotational recovery and stability
Time Frame
2 weeks prior to baseline, Baseline, 2 weeks post baseline
Title
Lens Fit Acceptance
Description
General lens fit acceptance for habitual lenses assessed 2 weeks prior to baseline and refitted with comfilcon A lenses, which were assessed at baseline and at 2 weeks. (Scale 0-4, 0=Can't be worn; 4=Optimum)
Time Frame
2 weeks prior to baseline, Baseline, 2 weeks post baseline
Title
Anterior Ocular Health - Palpebral Hyperemia and Roughness
Description
Palpebral hyperemia and roughness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None, 4=Severe
Time Frame
Baseline and 2 weeks
Title
Anterior Ocular Health - Bulbar and Limbal Redness
Description
Bulbar and limbal redness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None; 4=Severe injection
Time Frame
Baseline and 2 weeks
Title
Anterior Ocular Health - Corneal Staining
Description
Corneal staining for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=No staining; 4= >45% of area
Time Frame
Baseline and 2 weeks
Title
Anterior Ocular Health - Conjunctival Staining and Indentation
Description
Conjunctival staining and indentation for comfilcon A lenses assessed at baseline and 2 weeks. Conjuctival staining scale 0-4, 0=None, 4=Severe
Time Frame
Baseline and 2 weeks
Title
Visual Acuity
Description
Visual acuity for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A assessed at baseline and 2 weeks post baseline using logMAR.
Time Frame
2 weeks prior to baseline, Baseline, 2 weeks post baseline
Title
Subjective Preference - Comfort
Description
Subjective preference for comfort between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses
Time Frame
Baseline and 2 weeks
Title
Preference - Vision
Description
Subjective preference for vision between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses
Time Frame
Baseline and 2 weeks
Title
Preference - Handling
Description
Subjective preference for handling between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses
Time Frame
Baseline and 2 weeks
Title
Overall Preference
Description
Overall subjective preference between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses
Time Frame
Baseline and 2 weeks
Title
Investigator Acceptability
Description
Investigator's preference on acceptability of refitting subjects in to comfilcon A lens based on lens performance assessed at baseline and 2 weeks.Scale 1-5, 1=Strongly agree, 5=Strongly disagree.
Time Frame
Baseline and 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has had an oculo-visual examination in the last two years Is at least 18 years of age and has full legal capacity to volunteer Has read and understood the information consent letter Is willing and able to follow instructions and maintain the appointment schedule Is correctable to a visual acuity of 20/50 or better (in at least one eye) Currently wears soft toric contact lenses in both eyes Subject contact lens prescription must fall under one of the contact lens power ranges for at least one eye: -20.00D to -10.50D spherical powers and cylinder powers from - 0.75 to -2.25 +8.50D to +20.00D spherical powers and cylinder powers from - 0.75 to -2.25 -20.00D to -6.50D spherical powers and cylinder powers from -2.75 to -5.75 -6.00D to +6.00D spherical powers and cylinder powers from -2.75 to -5.75 +6.50D to +20.00D spherical powers and cylinder powers from-2.75 to -5.75 Has clear corneas and no active ocular disease Demonstrates an acceptable fit with the study lenses Exclusion Criteria: Has never worn contact lenses before; Has any systemic disease affecting ocular health; Is using any systemic or topical medications that will affect ocular health; Has any ocular pathology or abnormality that would affect the wearing of 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
Jan Bergmanson, OD PhD
Organizational Affiliation
Texas Eye Research and Technology Center (TERTC), School of Optometry, University of Houston
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pete Kollbaum, OD PhD
Organizational Affiliation
Clinical Optics Research Lab (CORL), Indiana University School of Optometry, Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47405
Country
United States
Facility Name
Texas Eye Research and Technology Center (TERTC) College of Optometry, University of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Multicenter Dispensing Study of Biofinity Toric Made-To-Order Lenses in Extended Power Ranges

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