Refitting Multifocal Contact Lens Wearers With a Different Multifocal Contact Lens

NCT06328660 | Completed Results FDA Device

• 1 other identifier: EX-MKTG-155
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to compare ease of handling and vision acuity of two multifocal contact lenses to correct presbyopia that are currently CE marked and on the UK market.

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

• Overall Lens Handling

  The ease of contact lens insertion and removal over the week preceding the follow-up visit measured on a 100-point visual analog scale, where 0=Very difficult, Painful and 100=Very easy, Can't feel the lenses

  1 week

Secondary Outcomes (3)

• Overall logMAR Visual Acuity - Dominant Eye

  14 days

• Overall logMAR Visual Acuity - Non-Dominant Eye

  14 days

• Overall logMAR Visual Acuity - Binocular

  14 days

Study Arms (2)

Lens 1

EXPERIMENTAL

All participants wore Lens 1 for 14 ± 3 days (Period 1)

Device: Lens 1

Lens 2

EXPERIMENTAL

All participants wore Lens 2 for 14 ± 3 days (Period 2)

Device: Lens 2

Interventions

Lens 1 DEVICE

Frequent replacement silicone hydrogel contact lens for 14 ± 3 days on a daily disposable wearing modality

Lens 1

Lens 2 DEVICE

Daily disposable silicone hydrogel contact lens for 14 ± 3 days on a daily disposable wearing modality

Lens 2

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40 years and older;
• Current multifocal contact lens wearer (other than MyDay® multifocal but can include Biofinity® multifocal);
• Spectacle refraction:
• Distance: Sphere: -6.00D to + 4.00D
• Astigmatism: 0.00D to -0.75D
• Near Addition: Low +0.75D to +1.25D; Medium +1.50D and +1.75D; High +2.00D to +2.50D
• Best corrected visual acuity of at least 20/25 in each eye. - The prospective participants will be given a Participant Information Sheet to read and an Informed Consent Form to sign prior to any evaluation.

You may not qualify if:

• To be eligible as a participant, each candidate shall be free of any ocular or medical condition that may affect the results of this study. The following are specific criteria that exclude a candidate from enrolment in this study:
• Acute and subacute inflammation or infection of the anterior chamber of the eye.
• Any eye disease, injury or abnormality that affects the cornea, conjunctiva or eyelids that would contraindicate contact lens wear;
• Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic
• Severe insufficiency of lacrimal secretion (dry eyes).
• Any systemic disease that may affect the eye or may be exaggerated by wearing contact lenses (e.g. acne and eczema).
• Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions
• Any active corneal infection (bacterial, fungal, protozoal or viral).
• Newly prescribed (within the past 30 days) use of some systemic medications (such as antihistamines, decongestants, diuretics, muscle relaxants, tranquilizers, stimulants, anti-depressants, anti-psychotics, oral contraceptives) or new prescription eyedrops which is not rewetting/lubricating eyedrops 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 contact lens;
• Subjects with slit lamp findings greater than grade 1 (e.g. edema, infiltrates, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival, anterior segment inflammation) as per ISO 11980, any previous history or signs of a contact lens related corneal inflammatory event (past corneal ulcers), or any other ocular abnormality that may contraindicate contact lens wear at the enrolment visit;
• History of corneal refractive surgery
• Enrolment of the family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals.
• Current wearer of the test contact lens, MyDay® Multifocal.

Sponsors & Collaborators

• CooperVision International Limited (CVIL): lead

Study Sites (1)

Ocular Technology Group - International

London, SW1E6AU, United Kingdom

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: José A. Vega
• Organization: CooperVision Inc.

JVega2@coopervision.com

+1 (925) 621-3761

Study Officials

• Michel Guillon, PhD FCOptom

  mguillon@otg.co.uk

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 25, 2024
• Study Start: February 15, 2024
• Primary Completion: May 21, 2024
• Study Completion: May 21, 2024
• Last Updated: July 28, 2025
• Results First Posted: July 17, 2025

Record last verified: 2024-07

Locations

GB (1)