ClinicalTrials.gg
CompletedNCT06869044Updated Apr 13, 2026

A Clinical Comparison of Proclear® 1 Day Multifocal and Clariti® 1 Day Multifocal 3 Add

An interventional study of omafilcon A lens and Low ADD power somofilcon A lens in Myopia, Hyperopia and Presbyopia, sponsored by CooperVision International Limited (CVIL). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.

Sponsored by CooperVision International Limited (CVIL) (part of CooperCompanies) · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Jun 2025, 1 year 4 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
67
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The aim of this study is to compare the overall lens satisfaction between two soft multifocal contact lenses.

Read the detailed description

The aim of the study is to evaluate the overall lens satisfaction between two soft multifocal contact lenses when compared to each other after 15 minutes of daily wear each.

02

Conditions studied

  • Myopia
  • Hyperopia
  • Presbyopia
03

In context

Myopia

1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.

This study's enrollment of 67 is below the median of 78 across 923 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

CooperVision International Limited (CVIL) is the lead sponsor of 138 studies on the registry; 6 are open to participants now.

Of its 74 completed or terminated interventional studies of FDA-regulated products, 66 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. They are at least 18 years of age.
  2. They understand their rights as a research subject and are willing and able to sign a Statement of .
  3. They habitually use soft contact lenses (multifocal soft contact lenses, sphere lenses for monovision, sphere lenses for distance vision correction and spectacles for near vision correction,) and have done so for at least the past three months.
  4. They have a minimum reading add of +0.75DS (based on their spectacle refraction)
  5. They have spherical equivalent refractive error between +6.00 to -10.00DS at the corneal plane and refractive astigmatism of no greater than -0.75DC in each eye.
  6. They are able to achieve distance HCVA of +0.10 logMAR or better in each eye.

Exclusion criteria

Exclusion Criteria:

  1. They have an ocular disorder which would normally contra-indicate contact lens wear.
  2. They have a systemic disorder which would normally contra-indicate contact lens wear.
  3. They are aphakic.
  4. They have had corneal refractive surgery.
  5. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
67 participants (actual)

Study arms

  • Experimental
    omafilcon A lenses first, then low ADD power somofilcon A lens

    Participants will wear two different types of study contact lenses, in a randomized order of testing for the two study contact lens types.

    Device: omafilcon A lens · Device: Low ADD power somofilcon A lens

  • Experimental
    omafilcon A lenses first, then medium ADD power somofilcon A lens

    Participants will wear two different types of study contact lenses, in a randomized order of testing for the two study contact lens types.

    Device: omafilcon A lens · Device: Medium ADD power somofilcon A lens

  • Experimental
    omafilcon A lenses first, then high ADD power somofilcon A lens

    Participants will wear two different types of study contact lenses, in a randomized order of testing for the two study contact lens types.

    Device: omafilcon A lens · Device: High ADD power somofilcon A lens

Interventions

  • Deviceomafilcon A lens

    Participants will be randomized to wear omafilcon A lens for 15 minutes.

  • DeviceLow ADD power somofilcon A lens

    Participants will be randomized to wear low ADD power somofilcon A lens for 15 minutes.

  • DeviceMedium ADD power somofilcon A lens

    Participants will be randomized to wear medium ADD power somofilcon A lens for 15 minutes.

  • DeviceHigh ADD power somofilcon A lens

    Participants will be randomized to wear high ADD power somofilcon A lens for 15 minutes.

06

What researchers measure

Primary outcomes

  1. Overall lens satisfaction

    Overall Impression recorded on a visual analog scale of 0 to 100 where (0=Extremely poor. Unmanageable. Cannot use lenses, 100=Excellent. Highly impressed with these lenses overall.)

    Time frame: At the end of 15 minutes wear

07

Study locations

1 site
  • University of California, Berkeley, CA
    Berkeley, California 94720, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06869044
Responsible party
Sponsor
First posted
Mar 11, 2025
Start date
Feb 11, 2025
Primary completion
Jun 26, 2025
Completion
Jun 26, 2025
Last update
Apr 13, 2026

Study contacts

Meng C Lin, OD, Ph.D
principal investigator · UC Berkeley

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion