MyopiaNCT04476784

Clinical Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens

A study testing Lehfilcon A contact lenses, Comfilcon A contact lenses and CLEAR CARE in people with Myopia, run by Alcon Research at 5 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 assess the clinical performance of an investigational contact lens 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: 66 participants
Where: 5 sitesUnited States
Study dates: 17 Aug 2020to 18 Nov 2020
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;
Current wearer of spherical weekly/monthly soft contact lenses in both eyes with at least 3 months wearing time of 5 days per week and 10 hours per day;
Other protocol-defined inclusion criteria may apply.

Who cannot join

Current or prior Biofinity contact lens wearer in the past 3 months;
Monovision contact lens wearer;
Other protocol-defined exclusion criteria may apply.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Alcon Investigative Site
Bloomington, Illinois, 61704
Alcon Investigative Site
Maitland, Florida, 32751
Alcon Investigative Site
Memphis, Tennessee, 38111
Alcon Investigative Site
Pittsburg, Kansas, 66762
Alcon Investigative Site
Shawnee Mission, Kansas, 66204

Other trials in United States

About this study

The purpose of this study is to assess the clinical performance of an investigational contact lens 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 60 days (30 days for each 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 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 cleaning and disinfecting solution

Study groups in NCT04476784
Study group	Role	What they receive
LID018869, then Biofinity	Other	Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product will be worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE will be used for nightly cleaning and disinfection. Receives: Device: Lehfilcon A contact lenses; Device: Comfilcon A contact lenses; Device: CLEAR CARE
Biofinity, then LID018869	Other	Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE will be used for nightly 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.

Mean Distance Visual Acuity (logMAR) With Study Lenses
Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). On Day 30, VA was assessed after 6-8 hours of wear. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.
Measured: Day 1, Day 30 after 6-8 hours of wear, each product

Timeline

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

17 Aug 202018 Nov 2020

First posted20 Jul 2020
Study start17 Aug 2020
Primary completion18 Nov 2020
Study completion18 Nov 2020

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: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04476784
Sponsor's protocol ID: CLY935-C013
Status last verified: Sep 2021
First submitted: 15 Jul 2020
Last updated: 26 Oct 2021
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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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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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens
ClinicalTrials.gov ID: NCT04476784
Acronym / sponsor ID: CLY935-C013
Conditions: Myopia
Keywords: Contact lenses
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 17 Aug 2020 (actual)
Primary completion: 18 Nov 2020 (actual)
Study completion: 18 Nov 2020 (actual)
First posted: 20 Jul 2020 (actual)
Results: Posted 26 Oct 2021

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 assess the clinical performance of an investigational contact lens over 30 days of daily wear.

Detailed description

Subjects will wear two products and be expected to attend 4 office visits. The individual duration of participation will be approximately 60 days (30 days for each product).

Study design

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

Arm	Type	Receives
LID018869, 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 product will be worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE will be used for nightly cleaning and disinfection.
Biofinity, then LID018869	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 product will be worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE will be used for nightly 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)

Able to understand and sign an approved Informed Consent form;
Willing and able to attend all scheduled study visits as required by the protocol;
Current wearer of spherical weekly/monthly soft contact lenses in both eyes with at least 3 months wearing time of 5 days per week and 10 hours per day;
Other protocol-defined inclusion criteria may apply.

Key exclusion criteria (3 listed)

Current or prior Biofinity contact lens wearer in the past 3 months;
Monovision contact lens wearer;
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	Biofinity, then LID018869, LID018869, then Biofinity
Comfilcon A contact lensesAlso: CooperVision® BIOFINITY®, BiofinityCommercially available silicone hydrogel contact lenses	Device	Biofinity, then LID018869, LID018869, then Biofinity
CLEAR CAREHydrogen peroxide-based cleaning and disinfecting solution	Device	Biofinity, then LID018869, LID018869, then Biofinity

Primary outcome

Mean Distance Visual Acuity (logMAR) With Study Lenses
Time frame: Day 1, Day 30 after 6-8 hours of wear, each product
Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). On Day 30, VA was assessed after 6-8 hours of wear. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.

Results and safety

Results posted to the registry on 26 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LID018869, Then Biofinity	31	30
Biofinity, Then LID018869	35	35

Primary outcome: Mean Distance Visual Acuity (logMAR) With Study Lenses

Time frame: Day 1, Day 30 after 6-8 hours of wear, each product. Mean (Standard Deviation). Unit: logMAR

Measure	LID018869 n = 66	Biofinity n = 65
Day 1	-0.11 (0.08)	-0.13 (0.08)
Day 30, after 6-8 hours of wear	-0.12 (0.07)	-0.13 (0.08)

Population analysed: Full Analysis Set: All randomized subjects who are exposed to any study lenses evaluated in this study.

Adverse events

Time frame: Adverse events (AE's) were collected from time of consent to study exit, approximately 60 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pretreatment	0 of 66 (0%)	0 of 66 (0%)	0 of 66
LID018869 - Ocular	0 of 132 (0%)	0 of 132 (0%)	0 of 132
LID018869 - Nonocular	0 of 66 (0%)	0 of 66 (0%)	0 of 66
Biofinity - Ocular	0 of 130 (0%)	0 of 130 (0%)	0 of 130
Biofinity - Nonocular	0 of 65 (0%)	0 of 65 (0%)	0 of 65

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
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.

Sr. Clinical Trial Lead, CDMA Vision Care study director

Alcon Research, LLC

5 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 5 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 3 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 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 26 Oct 2021). 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?

Mean Distance Visual Acuity (logMAR) With Study Lenses (time frame: Day 1, Day 30 after 6-8 hours of wear, each 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 NCT04476784.

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 26 Oct 2021.