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N/A N=66 Treatment

Refitting Multifocal Contact Lens Wearers With a Different Multifocal Contact Lens

Presbyopia

Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Overall Lens Handling — 96.0; 90.0 score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Lens 1 (Device); Lens 2 (Device)
Age
Adult, Older Adult · 40+ yrs
Sex
All
Sponsor
CooperVision International Limited (CVIL)
Primary completion
May 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Overall Lens Handling
96.0; 90.0
SECONDARY
Overall logMAR Visual Acuity - Dominant Eye
0.01; 0.01
SECONDARY
Overall logMAR Visual Acuity - Non-Dominant Eye
0.01; 0.00
SECONDARY
Overall logMAR Visual Acuity - Binocular
-0.05; -0.05

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.

Eligibility Criteria

Inclusion Criteria

  • 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.

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:

  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06328660). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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