Refitting Multifocal Contact Lens Wearers With a Different Multifocal Contact Lens

Refitting Biofinity Multifocal Contact Lens Wearer With MyDay Multifocal Contact Lenses

The purpose of this study is 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Presbyopia
• Intervention / Treatment: Device: Lens 1; Device: Lens 2

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW1E6AU
    • Ocular Technology Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lens 1; All participants will wear Lens 1 for 14 ± 3 days (Period 1)	Device: Lens 1; Frequent replacement silicone hydrogel contact lens for 14 ± 3 days on a daily disposable wearing modality
Experimental: Lens 2; All participants will wear Lens 2 for 14 ± 3 days (Period 2)	Device: Lens 2; Daily disposable silicone hydrogel contact lens for 14 ± 3 days on a daily disposable wearing modality

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall logMAR Visual Acuity	The mean logMAR visual acuity calculated as the mean of distance, intermediate, and near logMAR visual acuities.	14 days

Collaborators and Investigators

• Sponsor: Coopervision, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2024
• Primary Completion (Estimated): June 18, 2024
• Study Completion (Estimated): June 18, 2024

Study Registration Dates

• First Submitted: March 12, 2024
• First Submitted That Met QC Criteria: March 18, 2024
• First Posted (Actual): March 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: EX-MKTG-155

Drug and device information, study documents

• 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