Refitting Multifocal Contact Lens Wearers With a Different Multifocal Contact Lens

NCT ID: NCT06328660

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-15
• Study Completion Date: 2024-05-21

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.

Detailed Description

This was an interventional, prospective, open label, sequential design study. Participants wore each study contact lens on a daily disposable wearing modality for 14 ± 3 days and attended the clinic for a total of three study visits.

Conditions

Presbyopia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lens 1

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

Group Type: EXPERIMENTAL

Lens 1

Intervention Type: DEVICE

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

Lens 2

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

Group Type: EXPERIMENTAL

Lens 2

Intervention Type: DEVICE

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

Interventions

Lens 1

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

Intervention Type: DEVICE

Lens 2

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age 40 years and older;

2. Current multifocal contact lens wearer (other than MyDay® multifocal but can include Biofinity® multifocal);

3. 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

4. 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.

Exclusion Criteria

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:

1. Acute and subacute inflammation or infection of the anterior chamber of the eye.

2. Any eye disease, injury or abnormality that affects the cornea, conjunctiva or eyelids that would contraindicate contact lens wear;

3. Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic

4. Severe insufficiency of lacrimal secretion (dry eyes).

5. Any systemic disease that may affect the eye or may be exaggerated by wearing contact lenses (e.g. acne and eczema).

6. Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions

7. Any active corneal infection (bacterial, fungal, protozoal or viral).

8. 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;

9. Monocular participants (only one eye with functional vision) or participants fit with only one contact lens;

10. 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;

11. History of corneal refractive surgery

12. Enrolment of the family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals.

13. Current wearer of the test contact lens, MyDay® Multifocal.

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

Sponsors

CooperVision International Limited (CVIL)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michel Guillon, PhD FCOptom

Role: PRINCIPAL_INVESTIGATOR

mguillon@otg.co.uk

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

EX-MKTG-155

Identifier Type: -

Identifier Source: org_study_id