MyopiaNCT04942925

Clinical Comparison of Two Daily Disposable Contact Lenses - Pilot Study 3

A study testing Verofilcon A contact lenses and Kalifilcon A contact lenses in people with Myopia and Ametropia, run by Alcon Research at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the overall performance of PRECISION1™ contact lenses when compared to INFUSE™ contact lenses. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Myopia, Ametropia
What is being tested?: Verofilcon A contact lenses and Kalifilcon A contact lenses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 4 sitesUnited States
Study dates: 20 Jul 2021to 9 Sep 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Able to understand and sign an Informed Consent Form that been approved by an Institutional Review Board.
Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
Other protocol-defined inclusion criteria may apply.

Who cannot join

Current/previous PRECISION1 or INFUSE contact lens wearer.
Any eye condition or use of medication that contraindicates contact lens wear, as determined by the investigator.
Routinely sleeps in contact lenses.
Other protocol-defined exclusion criteria may apply.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Alcon Investigator 6583
Eden Prairie, Minnesota, 55344
Alcon Investigator 6565
Maitland, Florida, 32751
Alcon Investigator 6355
Orlando, Florida, 32803
Alcon Investigator 6313
Powell, Ohio, 43065

Other trials in United States

About this study

The purpose of this study is to evaluate the overall performance of PRECISION1™ contact lenses when compared to INFUSE™ contact lenses.

Read the detailed description

The expected duration of subject participation in the study is up to 24 days with 3 scheduled visits.

Conditions: Myopia, Ametropia
Being tested: Verofilcon A contact lenses, Kalifilcon A contact lenses
Keywords: Contact Lenses
Medical subject headings: Myopia, Refractive Errors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Verofilcon A contact lensesDevice
Also called PRECISION1™
Commercially available silicone hydrogel contact lenses for daily disposable wear
Kalifilcon A contact lensesDevice
Also called Bausch + Lomb INFUSE™
Commercially available silicone hydrogel contact lenses for daily disposable wear

Study groups in NCT04942925
Study group	Role	What they receive
Precision1, then Infuse	Other	Verofilcon A contact lenses worn first, with kalifilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality. Receives: Device: Verofilcon A contact lenses; Device: Kalifilcon A contact lenses
Infuse, then Precision1	Other	Kalifilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality. Receives: Device: Verofilcon A contact lenses; Device: Kalifilcon A contact lenses

What is being measured

The primary outcome is the main question the study is designed to answer.

Distance VA (logMAR) With Study Lenses
Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. No inferential testing was pre-specified for this endpoint.
Measured: Day 8 (-0/+3 days), each study lens type

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jul 20219 Sep 2021

First posted29 Jun 2021
Study start20 Jul 2021
Primary completion9 Sep 2021
Study completion9 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for MyopiaStudies of the same condition, open and under way.
More trials run by Alcon ResearchThe sponsor's other registered studies.
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
Model description: Subjects will receive treatment based upon the randomized treatment sequence assignment
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04942925
Sponsor's protocol ID: CLE383-E002
Status last verified: Aug 2022
First submitted: 21 Jun 2021
Last updated: 7 Sep 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Comparison of Two Daily Disposable Contact Lenses - Pilot Study 3
ClinicalTrials.gov ID: NCT04942925
Acronym / sponsor ID: CLE383-E002
Conditions: Myopia, Ametropia
Keywords: Contact Lenses
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 20 Jul 2021 (actual)
Primary completion: 9 Sep 2021 (actual)
Study completion: 9 Sep 2021 (actual)
First posted: 29 Jun 2021 (actual)
Results: Posted 7 Sep 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the overall performance of PRECISION1™ contact lenses when compared to INFUSE™ contact lenses.

Detailed description

The expected duration of subject participation in the study is up to 24 days with 3 scheduled visits.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: Subjects will receive treatment based upon the randomized treatment sequence assignment

Arm	Type	Receives
Precision1, then Infuse	Other	Device: Verofilcon A contact lenses, Device: Kalifilcon A contact lensesVerofilcon A contact lenses worn first, with kalifilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.
Infuse, then Precision1	Other	Device: Verofilcon A contact lenses, Device: Kalifilcon A contact lensesKalifilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Able to understand and sign an Informed Consent Form that been approved by an Institutional Review Board.
Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
Other protocol-defined inclusion criteria may apply.

Key exclusion criteria (4 listed)

Current/previous PRECISION1 or INFUSE contact lens wearer.
Any eye condition or use of medication that contraindicates contact lens wear, as determined by the investigator.
Routinely sleeps in contact lenses.
Other protocol-defined exclusion criteria may apply.

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
Verofilcon A contact lensesAlso: PRECISION1™Commercially available silicone hydrogel contact lenses for daily disposable wear	Device	Infuse, then Precision1, Precision1, then Infuse
Kalifilcon A contact lensesAlso: Bausch + Lomb INFUSE™Commercially available silicone hydrogel contact lenses for daily disposable wear	Device	Infuse, then Precision1, Precision1, then Infuse

Primary outcome

Distance VA (logMAR) With Study Lenses
Time frame: Day 8 (-0/+3 days), each study lens type
Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. No inferential testing was pre-specified for this endpoint.

Results and safety

Results posted to the registry on 7 Sep 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Precision1, Then Infuse	32	32
Infuse, Then Precision1	28	26

Primary outcome: Distance VA (logMAR) With Study Lenses

Time frame: Day 8 (-0/+3 days), each study lens type. Mean (Standard Deviation). Unit: logMAR

Measure	Precision1 n = 58	Infuse n = 58
Value	-0.14 (0.08)	-0.15 (0.07)

Population analysed: Safety Analysis Set: All subjects/eyes exposed to any study lenses evaluated in this study with non-missing response

Adverse events

Time frame: Adverse events (AE's) were collected from time of consent to study exit, approximately 24 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pretreatment	0 of 60 (0%)	0 of 60 (0%)	0 of 60
Precision1 Ocular	0 of 116 (0%)	0 of 116 (0%)	0 of 116
Precision1 Nonocular	0 of 58 (0%)	0 of 58 (0%)	0 of 58
Infuse Ocular	0 of 120 (0%)	0 of 120 (0%)	0 of 120
Infuse Nonocular	0 of 60 (0%)	0 of 60 (0%)	0 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Clinical Trial Lead, Vision Care study director

Alcon Research, LLC

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Verofilcon A contact lenses and Kalifilcon A contact lenses in people with Myopia and Ametropia, run by Alcon Research at 4 sites 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 3 inclusion and 4 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 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

Yes. Results are posted in the registry (first posted 7 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Distance VA (logMAR) With Study Lenses (time frame: Day 8 (-0/+3 days), each study lens type). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04942925.

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 7 Sep 2022.