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OpenTrials
Completed

NCT Number: NCT06328660

Refitting Multifocal Contact Lens Wearers With a Different Multifocal Contact Lens

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.

Completed

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ocular Technology Group - International

London, SW1E6AU, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lens 1

Device

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

Lens 2

Device

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

Primary outcomes

  1. Overall Lens Handling

    Time frame: 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 outcomes

  1. Overall logMAR Visual Acuity - Dominant Eye

    Time frame: 14 days

    The mean logMAR visual acuity of the dominant eye calculated as the mean of distance, intermediate, and near logMAR visual acuities. This value was recorded at the follow-up visit.

  2. Overall logMAR Visual Acuity - Non-Dominant Eye

    Time frame: 14 days

    The mean logMAR visual acuity of the non-dominant eye calculated as the mean of distance, intermediate, and near logMAR visual acuities. This value was recorded at the follow-up visit.

  3. Overall logMAR Visual Acuity - Binocular

    Time frame: 14 days

    The mean binocular logMAR visual acuity calculated as the mean of distance, intermediate, and near logMAR visual acuities. This value was recorded at the follow-up visit.

Sponsors and collaborators

Lead sponsor

CooperVision International Limited (CVIL)

Industry

Registry information

Official study title

Refitting Biofinity Multifocal Contact Lens Wearer With MyDay Multifocal Contact Lenses

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 25, 2024
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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