Clinical Validation Study of Comfilcon A Multifocal Toric Contact Lenses

NCT ID: NCT03417557

Last Updated: 2020-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-12
• Study Completion Date: 2018-04-03

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.

Conditions

Presbyopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Comfilcon A lens (test)

Intervention Type: DEVICE

contact lens

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.

Group Type: ACTIVE_COMPARATOR

Omafilcon B lens (control)

Intervention Type: DEVICE

contact lens

Interventions

Comfilcon A lens (test)

contact lens

Intervention Type: DEVICE

Omafilcon B lens (control)

contact lens

Intervention Type: DEVICE

Other Intervention Names

Biofinity multifocal toric Lens (test); Proclear multifocal toric lens (control)

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Bloomington, Indiana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CV-18-10

Identifier Type: -

Identifier Source: org_study_id