MyopiaNCT04980456

Clinical Assessment of Two Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lenses

A study testing Lehfilcon A contact lenses, Comfilcon A contact lenses and CLEAR CARE in people with Myopia, run by Alcon Research at 14 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 compare the clinical performance of TOTAL30 contact lenses with Biofinity contact lenses over 30 days of daily wear. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Myopia
What is being tested?: Lehfilcon A contact lenses, Comfilcon A contact lenses and CLEAR CARE
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 257 participants
Where: 14 sitesUnited States
Study dates: 5 Aug 2021to 20 Nov 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 approved Informed Consent form;
Willing and able to attend all scheduled study visits as required by the protocol;
Currently wearing any commercial spherical weekly/monthly soft contact lenses in both eyes for at least 3 months, minimum 5 days per week, 10 hours per day;
Manifest cylinder less than or equal to 0.75 diopter (D) in each eye;
Willing to stop wearing habitual contact lenses for the duration of study participation.
Other protocol-defined inclusion criteria may apply.

Who cannot join

Any eye condition that contraindicates contact lens wear, as determined by the Investigator;
Any use of systemic or ocular medicine that contraindicates contact lens wear, as determined by the Investigator;
Ocular or intraocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;
Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
Current or prior Biofinity contact lens wear in the past 3 months prior to consent.
Other protocol-defined exclusion criteria may apply.

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

Alcon Investigator 8175
Austin, Texas, 78731
Alcon Investigator 6356
Longwood, Florida, 32779
Alcon Investigator 8135
Los Angeles, California, 90012
Alcon Investigator 5582
Louisville, Kentucky, 40206
Alcon Investigator 6565
Maitland, Florida, 32751
Alcon Investigator 6353
Memphis, Tennessee, 38111
Alcon Investigator 8130
New York, New York, 10036
Alcon Investigator 8062
Oakland, California, 94607
Alcon Investigator 6567
Pittsburg, Kansas, 66762
Alcon Investigator 8106
San Francisco, California, 94127
Alcon Investigator 8097
Sterling Heights, Michigan, 48312
Alcon Investigator 6401
Warwick, Rhode Island, 02888
Alcon Investigator 6654
West Palm Beach, Florida, 33405
Alcon Investigator 7980
Willmar, Minnesota, 56201

Other trials in United States

About this study

The purpose of this study is to compare the clinical performance of TOTAL30 contact lenses with Biofinity contact lenses over 30 days of daily wear.

Read the detailed description

Subjects will wear two products and be expected to attend 4 office visits. The individual duration of participation will be approximately 65 days, which includes approximately 30 days of exposure to the test product and approximately 30 days of exposure to the comparator product.

Conditions: Myopia
Being tested: Lehfilcon A contact lenses, Comfilcon A contact lenses, CLEAR CARE
Keywords: Contact lenses
Medical subject headings: Myopia

What participants receive

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

Lehfilcon A contact lensesDevice
Also called TOTAL30
Investigational silicone hydrogel contact lenses
Comfilcon A contact lensesDevice
Also called CooperVision® Biofinity®, Biofinity
Commercially available silicone hydrogel contact lenses
CLEAR CAREDevice
Hydrogen peroxide-based cleaning and disinfecting solution

Study groups in NCT04980456
Study group	Role	What they receive
TOTAL30, then Biofinity	Other	Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses as randomized. Each study product will be worn bilaterally (in both eyes) for approximately 30 days for at least 10 hours per day during waking hours only. CLEAR CARE will be used for daily cleaning and disinfection. Receives: Device: Lehfilcon A contact lenses; Device: Comfilcon A contact lenses; Device: CLEAR CARE
Biofinity, then TOTAL30	Other	Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each study product will be worn bilaterally (in both eyes) for at least 10 hours per day during waking hours only. CLEAR CARE will be used for daily cleaning and disinfection. Receives: Device: Lehfilcon A contact lenses; Device: Comfilcon A contact lenses; Device: CLEAR CARE

What is being measured

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

Least Squares Mean 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.
Measured: Day 30, each study product

Timeline

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

5 Aug 202120 Nov 2021

First posted28 Jul 2021
Study start5 Aug 2021
Primary completion20 Nov 2021
Study completion20 Nov 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
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 257 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04980456
Sponsor's protocol ID: CLY935-C019
Status last verified: Dec 2022
First submitted: 19 Jul 2021
Last updated: 6 Jan 2023
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

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
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BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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Clinical Performance and Outcomes After Toric Lens Transition
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Active, not recruiting
Effect of IOP Lowering on Progressive HM
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Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Assessment of Two Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lenses
ClinicalTrials.gov ID: NCT04980456
Acronym / sponsor ID: CLY935-C019
Conditions: Myopia
Keywords: Contact lenses
Study type: Interventional
Recruitment status: Completed
Enrolment: 257 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 5 Aug 2021 (actual)
Primary completion: 20 Nov 2021 (actual)
Study completion: 20 Nov 2021 (actual)
First posted: 28 Jul 2021 (actual)
Results: Posted 6 Jan 2023

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 compare the clinical performance of TOTAL30 contact lenses with Biofinity contact lenses over 30 days of daily wear.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
TOTAL30, then Biofinity	Other	Device: Lehfilcon A contact lenses, Device: Comfilcon A contact lenses, Device: CLEAR CARELehfilcon A contact lenses worn first, followed by comfilcon A contact lenses as randomized. Each study product will be worn bilaterally (in both eyes) for approximately 30 days for at least 10 hours per day during waking hours only. CLEAR CARE will be used for daily cleaning and disinfection.
Biofinity, then TOTAL30	Other	Device: Lehfilcon A contact lenses, Device: Comfilcon A contact lenses, Device: CLEAR CAREComfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each study product will be worn bilaterally (in both eyes) for at least 10 hours per day during waking hours only. CLEAR CARE will be used for daily cleaning and disinfection.

Who may qualify

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

Key inclusion criteria (6 listed)

Able to understand and sign an approved Informed Consent form;
Willing and able to attend all scheduled study visits as required by the protocol;
Currently wearing any commercial spherical weekly/monthly soft contact lenses in both eyes for at least 3 months, minimum 5 days per week, 10 hours per day;
Manifest cylinder less than or equal to 0.75 diopter (D) in each eye;
Willing to stop wearing habitual contact lenses for the duration of study participation.

Key exclusion criteria (6 listed)

Any eye condition that contraindicates contact lens wear, as determined by the Investigator;
Any use of systemic or ocular medicine that contraindicates contact lens wear, as determined by the Investigator;
Ocular or intraocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;
Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
Current or prior Biofinity contact lens wear in the past 3 months prior to consent.

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
Lehfilcon A contact lensesAlso: TOTAL30Investigational silicone hydrogel contact lenses	Device	Biofinity, then TOTAL30, TOTAL30, then Biofinity
Comfilcon A contact lensesAlso: CooperVision® Biofinity®, BiofinityCommercially available silicone hydrogel contact lenses	Device	Biofinity, then TOTAL30, TOTAL30, then Biofinity
CLEAR CAREHydrogen peroxide-based cleaning and disinfecting solution	Device	Biofinity, then TOTAL30, TOTAL30, then Biofinity

Primary outcome

Least Squares Mean Distance VA (logMAR) With Study Lenses
Time frame: Day 30, each study product
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.

Results and safety

Results posted to the registry on 6 Jan 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TOTAL30, Then Biofinity	122	119
Biofinity, Then TOTAL30	127	124

Primary outcome: Least Squares Mean Distance VA (logMAR) With Study Lenses

Time frame: Day 30, each study product. Least squares mean (Standard Error). Unit: logMAR

Measure	TOTAL30 n = 240	Biofinity n = 243
Value	-0.07 (0.005)	-0.08 (0.005)

TOTAL30 vs Biofinity: Least Squares Mean Difference: 0.01

Population analysed: All subjects exposed to any study lenses evaluated in this study, as randomized, with non-missing response (eye)

Adverse events

Time frame: Adverse events (AE's) were collected from time of consent to study exit, approximately 65 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pretreatment	0 of 249 (0%)	0 of 249 (0%)	0 of 249
TOTAL30 Ocular	0 of 490 (0%)	0 of 490 (0%)	0 of 490
TOTAL30 Nonocular	2 of 245 (0.8%)	0 of 245 (0%)	0 of 245
Biofinity Ocular	0 of 492 (0%)	0 of 492 (0%)	0 of 492
Biofinity Nonocular	0 of 246 (0%)	0 of 246 (0%)	0 of 246

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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
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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

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

Questions about this trial

What is this clinical trial studying?

A study testing Lehfilcon A contact lenses, Comfilcon A contact lenses and CLEAR CARE in people with Myopia, run by Alcon Research at 14 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 6 inclusion and 6 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 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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 6 Jan 2023). 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?

Least Squares Mean Distance VA (logMAR) With Study Lenses (time frame: Day 30, each study product). 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 NCT04980456.

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 6 Jan 2023.