Refitting Multifocal Contact Lens Wearers With a Different Multifocal Contact Lens

Not Applicable

Completed

• Conditions: Presbyopia
• Interventions: Device: Lens 2; Device: Lens 1

• Registration Number: NCT06328660
• Lead Sponsor: Coopervision, Inc.

Brief Summary

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.

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 Timeline

• Study Start: 2024-02-15
• Study First Submitted: 2024-03-12
• Study First Submitted QC: 2024-03-18
• Study First Posted: 2024-03-25
• Primary Completion: 2024-05-21
• Study Completion: 2024-05-21
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Lens 2	Lens 2	All participants will wear Lens 2 for 14 ± 3 days (Period 2)
Lens 1	Lens 1	All participants will wear Lens 1 for 14 ± 3 days (Period 1)

Primary Outcome Measures

Name	Time	Method
Overall Lens Handling	1 week	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

Secondary Outcome Measures

Name	Time	Method
Overall logMAR Visual Acuity	14 days	The mean logMAR visual acuity calculated as the mean of distance, intermediate, and near logMAR visual acuities.

Trial Locations

Locations (1)

Ocular Technology Group; 🇬🇧 London, United Kingdom