MyopiaNCT06869044
A Clinical Comparison of Proclear® 1 Day Multifocal and Clariti® 1 Day Multifocal 3 Add
A study testing omafilcon A lens, Low ADD power somofilcon A lens and Medium ADD power somofilcon A lens in people with Myopia and Hyperopia, run by CooperVision International Limited (CVIL) at 1 site in United States.
Trial summary
The aim of this study is to compare the overall lens satisfaction between two soft multifocal contact lenses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopia, Hyperopia, Presbyopia
- What is being tested?
- omafilcon A lens, Low ADD power somofilcon A lens and Medium ADD power somofilcon A lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2025to 26 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- They are at least 18 years of age.
- They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
- 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.
- They have a minimum reading add of +0.75DS (based on their spectacle refraction)
- 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.
- They are able to achieve distance HCVA of +0.10 logMAR or better in each eye.
Who cannot join
- They have an ocular disorder which would normally contra-indicate contact lens wear.
- They have a systemic disorder which would normally contra-indicate contact lens wear.
- They are aphakic.
- They have had corneal refractive surgery.
- They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Berkeley, CA
Berkeley, California, 94720
About this study
Official title: A Clinical Comparison of Two Soft Multifocal Contact Lenses - Proclear® 1 Day Multifocal and Clariti® 1 Day Multifocal 3 Add
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.
- Conditions
- Myopia, Hyperopia, Presbyopia
- Being tested
- omafilcon A lens, Low ADD power somofilcon A lens, Medium ADD power somofilcon A lens, High ADD power somofilcon A lens
- Medical subject headings
- Myopia, Hyperopia, Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omafilcon A lensDevice
Participants will be randomized to wear omafilcon A lens for 15 minutes.
Low ADD power somofilcon A lensDevice
Participants will be randomized to wear low ADD power somofilcon A lens for 15 minutes.
Medium ADD power somofilcon A lensDevice
Participants will be randomized to wear medium ADD power somofilcon A lens for 15 minutes.
High ADD power somofilcon A lensDevice
Participants will be randomized to wear high ADD power somofilcon A lens for 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| omafilcon A lenses first, then low ADD power somofilcon A lens | Experimental | Participants will wear two different types of study contact lenses, in a randomized order of testing for the two study contact lens types. Receives: Device: omafilcon A lens; Device: Low ADD power somofilcon A lens |
| omafilcon A lenses first, then medium ADD power somofilcon A lens | Experimental | Participants will wear two different types of study contact lenses, in a randomized order of testing for the two study contact lens types. Receives: Device: omafilcon A lens; Device: Medium ADD power somofilcon A lens |
| omafilcon A lenses first, then high ADD power somofilcon A lens | Experimental | Participants will wear two different types of study contact lenses, in a randomized order of testing for the two study contact lens types. Receives: Device: omafilcon A lens; Device: High ADD power somofilcon A lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: At the end of 15 minutes wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start11 Feb 2025
- Primary completion26 Jun 2025
- Study completion26 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision International Limited (CVIL)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, Berkeley
- Responsible party
- Sponsor
- Investigators
- Meng C Lin, OD, Ph.D, Principal investigator, UC Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869044
- Sponsor's protocol ID
- EX-MKTG-165
- Status last verified
- Apr 2026
- First submitted
- 5 Mar 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Comparison of Two Soft Multifocal Contact Lenses - Proclear® 1 Day Multifocal and Clariti® 1 Day Multifocal 3 Add
- ClinicalTrials.gov ID
- NCT06869044
- Acronym / sponsor ID
- EX-MKTG-165
- Conditions
- Myopia, Hyperopia, Presbyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- CooperVision International Limited (CVIL)Industry (pharma, biotech, devices)
- Collaborators
- University of California, Berkeley
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 26 Jun 2025 (actual)
- Study completion
- 26 Jun 2025 (actual)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare the overall lens satisfaction between two soft multifocal contact lenses.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| omafilcon A lenses first, then low ADD power somofilcon A lens | Experimental | Device: omafilcon A lens, Device: Low ADD power somofilcon A lensParticipants will wear two different types of study contact lenses, in a randomized order of testing for the two study contact lens types. |
| omafilcon A lenses first, then medium ADD power somofilcon A lens | Experimental | Device: omafilcon A lens, Device: Medium ADD power somofilcon A lensParticipants will wear two different types of study contact lenses, in a randomized order of testing for the two study contact lens types. |
| omafilcon A lenses first, then high ADD power somofilcon A lens | Experimental | Device: omafilcon A lens, Device: High ADD power somofilcon A lensParticipants will wear two different types of study contact lenses, in a randomized order of testing for the two study contact lens types. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- They are at least 18 years of age.
- They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
- 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.
- They have a minimum reading add of +0.75DS (based on their spectacle refraction)
- 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.
Key exclusion criteria (5 listed)
- They have an ocular disorder which would normally contra-indicate contact lens wear.
- They have a systemic disorder which would normally contra-indicate contact lens wear.
- They are aphakic.
- They have had corneal refractive surgery.
- They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| omafilcon A lensParticipants will be randomized to wear omafilcon A lens for 15 minutes. | Device | omafilcon A lenses first, then high ADD power somofilcon A lens, omafilcon A lenses first, then low ADD power somofilcon A lens, omafilcon A lenses first, then medium ADD power somofilcon A lens |
| Low ADD power somofilcon A lensParticipants will be randomized to wear low ADD power somofilcon A lens for 15 minutes. | Device | omafilcon A lenses first, then low ADD power somofilcon A lens |
| Medium ADD power somofilcon A lensParticipants will be randomized to wear medium ADD power somofilcon A lens for 15 minutes. | Device | omafilcon A lenses first, then medium ADD power somofilcon A lens |
| High ADD power somofilcon A lensParticipants will be randomized to wear high ADD power somofilcon A lens for 15 minutes. | Device | omafilcon A lenses first, then high ADD power somofilcon A lens |
Primary outcome
Overall lens satisfaction
Time frame: At the end of 15 minutes wear
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.)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
Related trials for Myopia
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meng C Lin, OD, Ph.D principal investigator
UC Berkeley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing omafilcon A lens, Low ADD power somofilcon A lens and Medium ADD power somofilcon A lens in people with Myopia and Hyperopia, run by CooperVision International Limited (CVIL) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall lens satisfaction (time frame: At the end of 15 minutes wear). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.