Clinical Validation Study of Comfilcon A Multifocal Toric Contact Lenses

NCT03417557 | Completed Results FDA Device

• 1 other identifier: CV-18-10
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

• Visual Acuity

  Visual acuity is assessed for test and control lens on a logMAR chart

  up to 3 hours

Secondary Outcomes (3)

• Subjective Assessment of Visual Performance: Distance Day-time Navigation Tasks for Vision Quality and Clarity

  up to 3 hours

• Subjective Assessment of Visual Performance: Intermediate / Computer Task for Vision Quality and Clarity

  up to 3 hours

• Subjective Assessment of Visual Performance: Near Vision for Vision Quality and Clarity

  up to 3 hours

Study Arms (2)

Comfilcon A lens (test)

EXPERIMENTAL

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)

Omafilcon B Lens (control)

ACTIVE COMPARATOR

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)

Interventions

Comfilcon A lens (test) DEVICE

contact lens

Also known as: Biofinity multifocal toric Lens (test)

Comfilcon A lens (test)

Omafilcon B lens (control) DEVICE

contact lens

Also known as: Proclear multifocal toric lens (control)

Omafilcon B Lens (control)

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University

Bloomington, Indiana, 47405, United States

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Myhanh Nguyen, Sr. Optometrist
• Organization: CooperVision

MNguyen@coopervision.com

19257306716

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This will be, prospective, single-masked, randomized, bilateral, cross-over, non-dispensing study comparing the test lens against the control lens.

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: January 31, 2018
• Study Start: January 12, 2018
• Primary Completion: April 3, 2018
• Study Completion: April 3, 2018
• Last Updated: May 4, 2020
• Results First Posted: May 4, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)