Multifocal Contact Lenses Fitting Methods Comparison

Biofinity Multifocal Contact Lenses Fitting Methods Comparison

The purpose of this study was to compare the clinical performance of two fitting approaches for multifocal contact lenses.

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Device: Control Lenses (control fitting approach); Device: Test Lenses (test fitting approach)

Detailed Description

This was a prospective, cross-over, double-masked (participants and investigator), randomized order of testing study. It compared two fitting approaches for silicone hydrogel multifocal contact lenses to assess which method achieved greater vision satisfaction and performance.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW1E 6AU
    • Ocular Technology Group - International

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• At least 40 years old;
• Have read and understood the Participant Information Sheet;
• Have read, signed and dated the Informed Consent;
• Best corrected visual acuity of at least 20/25 in each eye;
• Have normal eyes with the exception of the need for visual correction;
• Current multifocal contact lens wearer;
• Spectacle refraction:

Distance: Sphere: -6.00D to + 4.00D Astigmatism: 0.00D to -0.75D Near Addition: Established Presbyopes: +1.50D & +1.75D

• Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule.

Exclusion Criteria:

• Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
• Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
• Monocular participants (only one eye with functional vision) or participants fit with only one lens;
• Any moderate or severe ocular condition observed during the slit-lamp examination at the enrolment visit;
• History of herpetic keratitis, ocular surgery or irregular cornea;
• Known pregnancy or lactation during the study period;
• Enrolment of the investigator or his/her staff, family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control Lenses, then Test Lenses; Participants wore the Control Lenses for 1 week, then crossed over to the Test Lenses for 1 week.	Device: Control Lenses (control fitting approach); Daily wear multifocal lenses for 1 week; Device: Test Lenses (test fitting approach); Daily wear multifocal lenses for 1 week
Experimental: Test Lenses, then Control Lens; Participants wore the Test Lenses for 1 week, then crossed over to the Control Lenses for 1 week.	Device: Control Lenses (control fitting approach); Daily wear multifocal lenses for 1 week; Device: Test Lenses (test fitting approach); Daily wear multifocal lenses for 1 week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Vision Satisfaction	Overall vision satisfaction for each lens was measured on a 0-100 point Visual Analog Scale (VAS), where 0=Extremely Unsatisfied and 100=Extremely Satisfied	One week
Overall Lens Preference	Participants selected their preferred lens fitting approach from options - 'Control', 'Test', or 'No Preference'	Two weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Binocular Visual Acuity Index	Mean binocular visual performance for each lens was measured by timed logMAR charts. Overall binocular logMAR visual acuity index was calculated by taking the mean of distance and near visual acuities	One week
Number of Contact Lenses	This measured the ease of fitting each contact lens. It counted the number of contact lenses (pair), selected as per the fitting guide, used to determine the final contact lens to dispense.	One week

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Michel Guillon, PhD, FCOptom, Ocular Technology Group - International

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2022
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: February 9, 2023
• First Submitted That Met QC Criteria: February 9, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: CV-22-49

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