Back to resultsClinical Validation Study of Comfilcon A Multifocal Toric Contact Lenses
Primary Purpose
Presbyopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Comfilcon A lens (test)
Omafilcon B lens (control)
Sponsored by
About this trial
This is an interventional treatment trial for Presbyopia
Eligibility Criteria
Inclusion Criteria:
- Has had a self-reported oculo-visual examination in the last two years.
- Is between ages 40-75 years, inclusive 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 able to participate in Parts A and B related to this work.
- Has a contact lens spherical prescription between +10.00 to 10.00D (inclusive).
- Has an Add component to their spectacle refraction (between +0.75 and +2.50DS).
- Has astigmatism between of -0.75 and -5.75DC (based on the calculated ocular refraction) in each eye.
- Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/25 best-corrected.
- Currently wears soft contact lenses.
- Has clear corneas and no active ocular disease.
- Has not worn lenses for at least 12 hours before the examination.
Exclusion Criteria:
A person will be excluded from the study if he/she:
- 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 severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
- Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
- Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
- Is aphakic.
- 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
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Comfilcon A lens (test)
Omafilcon B Lens (control)
Arm Description
Subjects are randomized to wear comfilcon A lens for up to 3 hours, either as first or second lens during this cross over study.
Subjects are randomized to wear omafilcon B lens for up to 3 hours, either as first or second lens during this cross over study.
Outcomes
Primary Outcome Measures
Visual Acuity
Visual acuity is assessed for test and control lens on a logMAR chart
Secondary Outcome Measures
Subjective Assessment of Visual Performance: Distance Day-time Navigation Tasks for Vision Quality and Clarity
Subjective assessment of visual performance for distance day-time navigation tasks for vision/clarity was assessed for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.
Subjective Assessment of Visual Performance: Intermediate / Computer Task for Vision Quality and Clarity
Subjective assessments of visual performance for intermediate / computer tasks for vision quality and clarity were assessed for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.
Subjective Assessment of Visual Performance: Near Vision for Vision Quality and Clarity
Subjective assessments of visual performance for near vision was assessed for vision quality and clarity for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03417557
Brief Title
Clinical Validation Study of Comfilcon A Multifocal Toric Contact Lenses
Official Title
Clinical Validation Study of Biofinity Multifocal Toric Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 12, 2018 (Actual)
Primary Completion Date
April 3, 2018 (Actual)
Study Completion Date
April 3, 2018 (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.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a study to evaluate the clinical performance and subjective acceptance of an investigational contact lens (test), compared to a marketed lens (control) in an in-office setting.
Detailed Description
This is a study to evaluate the clinical performance (including visual acuity, subjective assessments of visual performance, comfort ratings, vision preference and lens fit) of a comfilcon A investigational contact lens (test) compared to a control contact lens, in a non-dispensing setting. The main study hypothesis is the test contact lens will not be clinically inferior to the control lens.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This will be, prospective, single-masked, randomized, bilateral, cross-over, non-dispensing study comparing the test lens against the control lens.
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Comfilcon A lens (test)
Arm Type
Experimental
Arm Description
Subjects are randomized to wear comfilcon A lens for up to 3 hours, either as first or second lens during this cross over study.
Arm Title
Omafilcon B Lens (control)
Arm Type
Active Comparator
Arm Description
Subjects are randomized to wear omafilcon B lens for up to 3 hours, either as first or second lens during this cross over study.
Intervention Type
Device
Intervention Name(s)
Comfilcon A lens (test)
Other Intervention Name(s)
Biofinity multifocal toric Lens (test)
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
Omafilcon B lens (control)
Other Intervention Name(s)
Proclear multifocal toric lens (control)
Intervention Description
contact lens
Primary Outcome Measure Information:
Title
Visual Acuity
Description
Visual acuity is assessed for test and control lens on a logMAR chart
Time Frame
up to 3 hours
Secondary Outcome Measure Information:
Title
Subjective Assessment of Visual Performance: Distance Day-time Navigation Tasks for Vision Quality and Clarity
Description
Subjective assessment of visual performance for distance day-time navigation tasks for vision/clarity was assessed for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.
Time Frame
up to 3 hours
Title
Subjective Assessment of Visual Performance: Intermediate / Computer Task for Vision Quality and Clarity
Description
Subjective assessments of visual performance for intermediate / computer tasks for vision quality and clarity were assessed for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.
Time Frame
up to 3 hours
Title
Subjective Assessment of Visual Performance: Near Vision for Vision Quality and Clarity
Description
Subjective assessments of visual performance for near vision was assessed for vision quality and clarity for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.
Time Frame
up to 3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has had a self-reported oculo-visual examination in the last two years.
Is between ages 40-75 years, inclusive 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 able to participate in Parts A and B related to this work.
Has a contact lens spherical prescription between +10.00 to 10.00D (inclusive).
Has an Add component to their spectacle refraction (between +0.75 and +2.50DS).
Has astigmatism between of -0.75 and -5.75DC (based on the calculated ocular refraction) in each eye.
Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/25 best-corrected.
Currently wears soft contact lenses.
Has clear corneas and no active ocular disease.
Has not worn lenses for at least 12 hours before the examination.
Exclusion Criteria:
A person will be excluded from the study if he/she:
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 severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
Is aphakic.
Has undergone corneal refractive surgery.
Is participating in any other type of eye related clinical or research study.
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Validation Study of Comfilcon A Multifocal Toric Contact Lenses
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