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Multifocal Contact Lenses Fitting Methods Comparison

Sponsor
Coopervision, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT05734846
Collaborator
(none)
27
Enrollment
1
Location
2
Arms
1.7
Actual Duration (Months)
16.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study compares two fitting approaches to multifocal contact lenses.

Condition or Disease Intervention/Treatment Phase
  • Device: Control Lenses
  • Device: Test Lenses
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
27 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Biofinity Multifocal Contact Lenses Fitting Methods Comparison
Actual Study Start Date :
Oct 11, 2022
Actual Primary Completion Date :
Dec 1, 2022
Actual Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Silicone Hydrogel Multifocal Control Lenses

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

Device: Control Lenses
D design fitted to both dominant and non-dominant eyes

Device: Test Lenses
D design fitted to dominant eye and N design fitted to non-dominant eye
Experimental: Silicone Hydrogel Multifocal Test Lenses

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

Device: Control Lenses
D design fitted to both dominant and non-dominant eyes

Device: Test Lenses
D design fitted to dominant eye and N design fitted to non-dominant eye

Outcome Measures

Primary Outcome Measures

  1. Overall binocular vision satisfaction [one week of wear]

    Overall binocular vision satisfaction will be measured on a 100-point Visual Analog Scale where 0 represents extremely unsatisfied and 100 is extremely satisfied.

  2. Overall preference [one week of wear each]

    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

  1. Mean binocular visual performance visual acuity [one week of wear]

    Mean binocular visual performance measured by timed logMAR charts (this is the mean of distance and near visual acuities)

  2. Number of contact lenses needed per participant to determine the contact lens pair to be dispensed [one week of wear each]

    Number of contact lenses needed per participant to determine the contact lens pair to be dispensed

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ocular Technology Group - International London United Kingdom SW1E 6AU

Sponsors and Collaborators

  • Coopervision, Inc.

Investigators

  • Principal Investigator: Michel Guillon, PhD, FCOptom, Ocular Technology Group - International

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT05734846
Other Study ID Numbers:
  • CV-22-49
First Posted:
Feb 21, 2023
Last Update Posted:
Feb 21, 2023
Last Verified:
Feb 1, 2023
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
Additional relevant MeSH terms:
Presbyopia

Study Results

No Results Posted as of Feb 21, 2023