Clinical Evaluation of Investigational Multifocal Toric Contact Lenses

Clinical Evaluation of Biofinity Multifocal Toric Contact Lenses

This non-dispensing study is to evaluate the clinical performance of a test multifocal toric silicone hydrogel contact lens compared to a marketed multifocal toric contact lens (control).

Study Overview

• Status: Completed
• Conditions: Presbyopia; Astigmatism
• Intervention / Treatment: Device: comfilcon A multifocal toric lens; Device: omafilcon A Multifocal Toric Lens

Detailed Description

This non-dispensing study is to evaluate the clinical performance of a test multifocal toric silicone hydrogel contact lens compared to a marketed multifocal toric contact lens (control).

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M13 9PL
    • Eurolens Research

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 aged 40-75 years, inclusive and has full legal capacity to volunteer.
• Has read and understood the participant information sheet.
• 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 -0.75 and -5.75DC (based on the vertexed ocular refraction in each eye.
• Can be satisfactorily fitted with the study lenses.
• Is correctable to a visual acuity of 20/40 (0.30 logMAR) or better (in each eye) with their habitual vision correction or 20/25 (0.10 logMAR) best-corrected.
• They have successfully worn soft contact lenses in the last six months
• Has clear corneas and no active ocular disease.
• Has not worn lenses for at least 12 hours before the examination.
• Has an up-to-date pair of spectacles.

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 severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would, in the opinion of the investigator, affect the wearing of contact lenses.
• Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye that would, in the opinion of the investigator, be problematic for their participation in the study.
• Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
• Is aphakic.
• Has undergone corneal refractive surgery.
• Has a history of anaphylaxis or severe allergic reaction.
• Has diabetes or an infectious or immunosuppressive disease which could contraindicate contact lens wear or pose a risk to the investigator.
• They are pregnant or breast-feeding.
• 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 Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Multifocal Toric Lens; comfilcon A multifocal toric lens	Device: comfilcon A multifocal toric lens; contact lens; Other Names: Test Multifocal Toric Lens; Biofinity multifocal toric lens; Device: omafilcon A Multifocal Toric Lens; contact lens; Other Names: Proclear multifocal toric lens; Control multifocal toric lens
Active Comparator: omafilcon A Multifocal Toric Lens; Control multifocal toric lens	Device: comfilcon A multifocal toric lens; contact lens; Other Names: Test Multifocal Toric Lens; Biofinity multifocal toric lens; Device: omafilcon A Multifocal Toric Lens; contact lens; Other Names: Proclear multifocal toric lens; Control multifocal toric lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity	Visual Acuity (measured in LogMAR)	Up to 2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Visual Performance: Distance Navigation Tasks for Vision Quality and Clarity	Subjective assessment of visual performance for distance navigation tasks for vision quality and clarity was assessed on a scale 0-100, 0=poor, 100=excellent.	Up to 2 hours
Assessment of Visual Performance: Intermediate Task for Vision Quality and Clarity	Subjective assessment of visual performance for intermediate task for vision quality and clarity was assessed on a scale 0-100, 0=poor, 100=excellent.	Up to 2 hours
Assessment of Visual Performance: Near Task for Vision Quality and Clarity	Subjective assessment of visual performance for near task for vision quality and clarity was assessed on a scale 0-100, 0=poor, 100=excellent.	Up to 2 hours

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Philip Morgan, BSc, PhD, MCOptom, Eurolens Research

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2018
• Primary Completion (Actual): July 24, 2018
• Study Completion (Actual): July 24, 2018

Study Registration Dates

• First Submitted: April 26, 2018
• First Submitted That Met QC Criteria: April 26, 2018
• First Posted (Actual): May 8, 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; Astigmatism
• Other Study ID Numbers: CV-18-11

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.: Yes