Clinical Validation Study of Comfilcon A Multifocal Toric Contact Lenses

Clinical Validation Study of Biofinity Multifocal Toric Contact Lenses

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.

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Device: Comfilcon A lens (test); Device: Omafilcon B lens (control)

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Bloomington, Indiana, United States, 47405
      • Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Comfilcon A lens (test); Subjects are randomized to wear comfilcon A lens for up to 3 hours, either as first or second lens during this cross over study.	Device: Comfilcon A lens (test); contact lens; Other Names: Biofinity multifocal toric Lens (test)
ACTIVE_COMPARATOR: Omafilcon B Lens (control); Subjects are randomized to wear omafilcon B lens for up to 3 hours, either as first or second lens during this cross over study.	Device: Omafilcon B lens (control); contact lens; Other Names: Proclear multifocal toric lens (control)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity	Visual acuity is assessed for test and control lens on a logMAR chart	up to 3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 3 hours
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.	up to 3 hours
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.	up to 3 hours

Collaborators and Investigators

• Sponsor: Coopervision, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 12, 2018
• Primary Completion (ACTUAL): April 3, 2018
• Study Completion (ACTUAL): April 3, 2018

Study Registration Dates

• First Submitted: January 25, 2018
• First Submitted That Met QC Criteria: January 25, 2018
• First Posted (ACTUAL): January 31, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 4, 2020
• Last Update Submitted That Met QC Criteria: April 30, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: CV-18-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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