Refractive ErrorsNCT04422990

Clinical Evaluation of a Silicone Hydrogel Daily Wear Monthly Replacement Contact Lens

A study testing Lehfilcon A contact lenses, Comfilcon A contact lenses and CLEAR CARE in people with Refractive Errors, 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 clinical study is to evaluate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear modality. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Refractive Errors
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: 158 participants
Where: 14 sitesUnited States
Study dates: 1 Oct 2020to 18 May 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

Successful wear of spherical daily wear frequent replacement soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day;
Manifest cylinder equal to or less than 0.75 diopter (D) in each eye;
Best spectacle corrected visual acuity (using manifest refraction) of 20/20 or better in each eye;
Other protocol-defined inclusion criteria may apply.

Who cannot join

Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
Habitually wearing Biofinity lenses;
Monovision or multifocal contact lens wearers;
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 Investigative Site
Boiling Springs, South Carolina, 29316
Alcon Investigative Site
Cleveland, Ohio, 44106
Alcon Investigative Site
Downers Grove, Illinois, 60515
Alcon Investigative Site
Los Angeles, California, 90012
Alcon Investigative Site
Louisville, Kentucky, 40221
Alcon Investigative Site
New York, New York, 10036
Alcon Investigative Site
Novato, California, 94945
Alcon Investigative Site
Oakland, California, 94513
Alcon Investigative Site
Oakland, California, 94607
Alcon Investigative Site
Orlando, Florida, 32803
Alcon Investigative Site
Plano, Texas, 75093
Alcon Investigative Site
San Francisco, California, 94122
Alcon Investigative Site
West Palm Beach, Florida, 33405
Alcon Investigative Site
Wichita Falls, Texas, 76308

Other trials in United States

About this study

Read the detailed description

Subjects will be expected to attend 4 office visits: Screening/Baseline/Dispense, Week 1 Follow-up, Month 1 Follow-up, and Month 3 Follow-up/Exit. The total expected duration of participation for each subject is approximately 3-4 months in this daily wear clinical study.

Conditions: Refractive Errors
Being tested: Lehfilcon A contact lenses, Comfilcon A contact lenses, CLEAR CARE
Keywords: Vision Correction, Contact Lens
Medical subject headings: Refractive Errors

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 LID018869
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 contact lens cleaning and disinfecting solution

Study groups in NCT04422990
Study group	Role	What they receive
LID018869	Experimental	Lehfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses will be worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE will be used for nightly contact lens cleaning and disinfection. Receives: Device: Lehfilcon A contact lenses; Device: CLEAR CARE
Biofinity	Active comparator	Comfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses will be worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE will be used for nightly contact lens cleaning and disinfection. Receives: 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 Contact Lens Corrected Distance Visual Acuity (CLCDVA) at Week 1 Follow-Up
Visual acuity (VA) was assessed for each eye individually with study lenses in place using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity.
Measured: Week 1 Follow-Up

Secondary outcomes (1)

Percentage of Subjects Achieving CLCDVA 20/20 or Better in Each Eye at Week 1 Follow-Up
Visual acuity (VA) was assessed for each eye individually with study lenses in place using a letter chart. VA was collected in Snellen, with 20/20 Snellen visual acuity considered normal distance eyesight. Subjects achieving at least 20/20 Snellen in each eye, left and right, contributed to the analysis.
Measured: Week 1 Follow-Up

Timeline

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

1 Oct 202018 May 2021

First posted9 Jun 2020
Study start1 Oct 2020
Primary completion22 Feb 2021
Study completion18 May 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 Refractive ErrorsStudies 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: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 158 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04422990
Sponsor's protocol ID: CLY935-C012
Status last verified: Mar 2022
First submitted: 5 Jun 2020
Last updated: 29 Mar 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

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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RecruitingPhase 1/2
Psilocybin for Amblyopia - Targeting Critical Periods in Humans
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Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
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All Refractive Errors trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of a Silicone Hydrogel Daily Wear Monthly Replacement Contact Lens
ClinicalTrials.gov ID: NCT04422990
Acronym / sponsor ID: CLY935-C012
Conditions: Refractive Errors
Keywords: Vision Correction, Contact Lens
Study type: Interventional
Recruitment status: Completed
Enrolment: 158 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 1 Oct 2020 (actual)
Primary completion: 22 Feb 2021 (actual)
Study completion: 18 May 2021 (actual)
First posted: 9 Jun 2020 (actual)
Results: Posted 24 Feb 2022

Clinical summary

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

Detailed description

Study design

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

Arm	Type	Receives
LID018869	Experimental	Device: Lehfilcon A contact lenses, Device: CLEAR CARELehfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses will be worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE will be used for nightly contact lens cleaning and disinfection.
Biofinity	Active comparator	Device: Comfilcon A contact lenses, Device: CLEAR CAREComfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses will be worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE will be used for nightly contact lens 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 (4 listed)

Successful wear of spherical daily wear frequent replacement soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day;
Manifest cylinder equal to or less than 0.75 diopter (D) in each eye;
Best spectacle corrected visual acuity (using manifest refraction) of 20/20 or better in each eye;
Other protocol-defined inclusion criteria may apply.

Key exclusion criteria (4 listed)

Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
Habitually wearing Biofinity lenses;
Monovision or multifocal contact lens wearers;
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
Lehfilcon A contact lensesAlso: LID018869Investigational silicone hydrogel contact lenses	Device	LID018869
Comfilcon A contact lensesAlso: CooperVision® BIOFINITY®, BiofinityCommercially available silicone hydrogel contact lenses	Device	Biofinity
CLEAR CAREHydrogen peroxide-based contact lens cleaning and disinfecting solution	Device	Biofinity, LID018869

Primary outcome

Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) at Week 1 Follow-Up
Time frame: Week 1 Follow-Up
Visual acuity (VA) was assessed for each eye individually with study lenses in place using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity.

1 secondary outcome

Percentage of Subjects Achieving CLCDVA 20/20 or Better in Each Eye at Week 1 Follow-Up
Time frame: Week 1 Follow-Up

Results and safety

Results posted to the registry on 24 Feb 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
Biofinity	50	47
LID018869	97	96

Primary outcome: Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) at Week 1 Follow-Up

Time frame: Week 1 Follow-Up. Least squares mean (Standard Error). Unit: logMAR

Measure	Biofinity n = 88	LID018869 n = 170
Value	-0.06 (0.00)	-0.06 (0.00)

Biofinity vs LID018869: Least squares mean difference: 0.00 (95% CI -0.01 to 0.01), Mixed effects repeated measures model

Population analysed: PP: A predefined subset of subjects (those with BCVA of 20/20 or better in each eye at baseline/dispense) from another similar completed registration study, CLY935-C010 (NCT04178720) was combined with this study to attain adequate power for the planned hypothesis testing of the primary and secondary endpoints. This included 49 subjects from CLY935-C012 and 39 subjects from CLY935-C010 in the Biofinity group and 92 subjects from CLY935-C012 and 78 subjects from CLY935-C010 in the LID018869 group.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events (AE's) were collected from time of consent to study exit, approximately 3 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pre-Treatment	0 of 147 (0%)	0 of 147 (0%)	0 of 147
Biofinity Ocular	0 of 100 (0%)	0 of 100 (0%)	0 of 100
Biofinity Non-Ocular	0 of 50 (0%)	0 of 50 (0%)	0 of 50
LID018869 Ocular	0 of 194 (0%)	0 of 194 (0%)	0 of 194
LID018869 Non-Ocular	0 of 97 (0%)	0 of 97 (0%)	0 of 97

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Refractive Errors

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
RecruitingPhase 1/2
Psilocybin for Amblyopia - Targeting Critical Periods in Humans
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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.

Sr. Clinical Trial Lead, CDMA 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 Refractive Errors, 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 4 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 29 Mar 2022. 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 24 Feb 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?

Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) at Week 1 Follow-Up (time frame: Week 1 Follow-Up). 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 NCT04422990.

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 29 Mar 2022.