Multifocal Contact Lenses Fitting Methods Comparison

NCT ID: NCT05734846

Last Updated: 2024-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-11
• Study Completion Date: 2022-12-01

Brief Summary

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

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.

Conditions

Presbyopia

Study Design

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

Study Groups

Control Lenses, then Test Lenses

Participants wore the Control Lenses for 1 week, then crossed over to the Test Lenses for 1 week.

Group Type: EXPERIMENTAL

Control Lenses (control fitting approach)

Intervention Type: DEVICE

Daily wear multifocal lenses for 1 week

Test Lenses (test fitting approach)

Intervention Type: DEVICE

Daily wear multifocal lenses for 1 week

Test Lenses, then Control Lens

Participants wore the Test Lenses for 1 week, then crossed over to the Control Lenses for 1 week.

Group Type: EXPERIMENTAL

Control Lenses (control fitting approach)

Intervention Type: DEVICE

Daily wear multifocal lenses for 1 week

Test Lenses (test fitting approach)

Intervention Type: DEVICE

Daily wear multifocal lenses for 1 week

Interventions

Control Lenses (control fitting approach)

Daily wear multifocal lenses for 1 week

Intervention Type: DEVICE

Test Lenses (test fitting approach)

Daily wear multifocal lenses for 1 week

Intervention Type: DEVICE

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.

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

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michel Guillon, PhD, FCOptom

Role: PRINCIPAL_INVESTIGATOR

Ocular Technology Group - International

Locations

Ocular Technology Group - International

London, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CV-22-49

Identifier Type: -

Identifier Source: org_study_id