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Multifocal Contact Lenses Fitting Methods Comparison

Primary Purpose

Presbyopia

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Control Lenses
Test Lenses
Sponsored by
Coopervision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presbyopia

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ocular Technology Group - International

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Silicone Hydrogel Multifocal Control Lenses

Silicone Hydrogel Multifocal Test Lenses

Arm Description

Participant will wear Control Lenses for one week, then crossover to Experimental Lenses for one week.

Participant will wear Test Lenses for one week, then crossover to Control Lenses for one week.

Outcomes

Primary Outcome Measures

Overall binocular vision satisfaction
Overall binocular vision satisfaction will be measured on a 100-point Visual Analog Scale where 0 represents extremely unsatisfied and 100 is extremely satisfied.
Overall preference
Overall preference is measured on a forced choice scale, where the responses to the question "Please indicate below which lenses you worn in the study you prefer for overall vision by selecting first lens or the second lens from the drop-down menu." are as follows: Prefer contact lens 1 strongly Prefer contact lens 1 slightly No preference Prefer contact lens 2 slightly Prefer contact lens 2 strongly

Secondary Outcome Measures

Mean binocular visual performance visual acuity
Mean binocular visual performance measured by timed logMAR charts (this is the mean of distance and near visual acuities)
Number of contact lenses needed per participant to determine the contact lens pair to be dispensed
Number of contact lenses needed per participant to determine the contact lens pair to be dispensed

Full Information

First Posted
February 9, 2023
Last Updated
February 9, 2023
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05734846
Brief Title
Multifocal Contact Lenses Fitting Methods Comparison
Official Title
Biofinity Multifocal Contact Lenses Fitting Methods Comparison
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 11, 2022 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study compares two fitting approaches to multifocal contact lenses.
Detailed Description
This study compares two common fitting approaches to fit Silicone Hydrogel Multifocal contact lenses to assess which one achieves the best results to support proposing that fitting approach for the selection of the first contact lenses to try.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Silicone Hydrogel Multifocal Control Lenses
Arm Type
Active Comparator
Arm Description
Participant will wear Control Lenses for one week, then crossover to Experimental Lenses for one week.
Arm Title
Silicone Hydrogel Multifocal Test Lenses
Arm Type
Experimental
Arm Description
Participant will wear Test Lenses for one week, then crossover to Control Lenses for one week.
Intervention Type
Device
Intervention Name(s)
Control Lenses
Intervention Description
D design fitted to both dominant and non-dominant eyes
Intervention Type
Device
Intervention Name(s)
Test Lenses
Intervention Description
D design fitted to dominant eye and N design fitted to non-dominant eye
Primary Outcome Measure Information:
Title
Overall binocular vision satisfaction
Description
Overall binocular vision satisfaction will be measured on a 100-point Visual Analog Scale where 0 represents extremely unsatisfied and 100 is extremely satisfied.
Time Frame
one week of wear
Title
Overall preference
Description
Overall preference is measured on a forced choice scale, where the responses to the question "Please indicate below which lenses you worn in the study you prefer for overall vision by selecting first lens or the second lens from the drop-down menu." are as follows: Prefer contact lens 1 strongly Prefer contact lens 1 slightly No preference Prefer contact lens 2 slightly Prefer contact lens 2 strongly
Time Frame
one week of wear each
Secondary Outcome Measure Information:
Title
Mean binocular visual performance visual acuity
Description
Mean binocular visual performance measured by timed logMAR charts (this is the mean of distance and near visual acuities)
Time Frame
one week of wear
Title
Number of contact lenses needed per participant to determine the contact lens pair to be dispensed
Description
Number of contact lenses needed per participant to determine the contact lens pair to be dispensed
Time Frame
one week of wear each

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Guillon, PhD, FCOptom
Organizational Affiliation
Ocular Technology Group - International
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ocular Technology Group - International
City
London
ZIP/Postal Code
SW1E 6AU
Country
United Kingdom

12. IPD Sharing Statement

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Multifocal Contact Lenses Fitting Methods Comparison

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