PresbyopiaNCT05338333

Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses

A study testing Lehfilcon A multifocal contact lenses, Lotrafilcon B multifocal contact lenses and CLEAR CARE® in people with Presbyopia, run by Alcon Research at 8 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 primary objective of this study is to demonstrate noninferiority in visual acuity at distance when wearing the test contact lenses (LID210464) compared to the control contact lenses (AOHG MF) after 30 days of wear. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Presbyopia
What is being tested?: Lehfilcon A multifocal contact lenses, Lotrafilcon B multifocal contact lenses and CLEAR CARE®
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 101 participants
Where: 8 sitesUnited States
Study dates: 27 May 2022to 1 Sep 2022
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 40 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 has been approved by an Institutional Review Board.
Willing and able to attend all study visits as required by the protocol.
Willing to stop wearing habitual contact lenses for the duration of the study.
Currently wearing daily disposable and biweekly/monthly replacement multifocal soft contact lenses in both eyes at least 5 days per week and at least 8 hours per day for at least 3 months. AOHG MF wearers may be included.
Other protocol-specified inclusion criteria may apply.

Who cannot join

Any eye infection, inflammation, abnormality, or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator.
Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator.
History of refractive surgery or planning to have refractive surgery during the study.
Current or history of pathologically dry eye.
Currently pregnant or lactating.
Other protocol-specified exclusion criteria may apply.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

The Eye Doctors, Inc.
Eden Prairie, Minnesota, 55344
ProCare Vision Centers, Inc.
Granville, Ohio, 43023
Kindred Optics at Maitland Vision
Maitland, Florida, 32751
Complete Eye Care of Medina
Medina, Minnesota, 55340
Optometry Group, PLLC
Memphis, Tennessee, 38111
Vision Health Institute
Orlando, Florida, 32803
Kannarr Eye Care LLC
Pittsburg, Kansas, 66762
West Bay Eye Associates
Warwick, Rhode Island, 02888

Other trials in United States

About this study

Read the detailed description

Subjects will be expected to attend 4 office visits and will be dispensed study contact lenses (test lenses and control lenses) for a 30-day duration of bilateral wear for each study lens type (total of approximately 60 days of contact lens wear).

Conditions: Presbyopia
Being tested: Lehfilcon A multifocal contact lenses, Lotrafilcon B multifocal contact lenses, CLEAR CARE®
Keywords: Contact lenses, Multifocal
Medical subject headings: Presbyopia

What participants receive

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

Lehfilcon A multifocal contact lensesDevice
Also called LID210464
Investigational frequent replacement soft contact lens indicated for the optical correction of presbyopia
Lotrafilcon B multifocal contact lensesDevice
Also called AOHG MF, AIR OPTIX® plus HydraGlyde® Multifocal (AOHG MF) contact lenses
Commercially available frequent replacement soft contact lens indicated for the optical correction of presbyopia
CLEAR CARE®Device
Hydrogen peroxide-based contact lens cleaning and disinfecting solution

Study groups in NCT05338333
Study group	Role	What they receive
LID210464, then AOHG MF	Other	Lehfilcon A multifocal contact lenses (LID210464) worn in Period 1, with lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 30 days. CLEAR CARE® will be used for nightly contact lens cleaning and disinfecting. Receives: Device: Lehfilcon A multifocal contact lenses; Device: Lotrafilcon B multifocal contact lenses; Device: CLEAR CARE®
AOHG MF, then LID210464	Other	Lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 1, with lehfilcon A multifocal contact lenses (LID210464) worn in Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 30 days. CLEAR CARE® will be used for nightly contact lens cleaning and disinfecting. Receives: Device: Lehfilcon A multifocal contact lenses; Device: Lotrafilcon B multifocal 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 Binocular High Contrast/High Illumination Visual Acuity at Distance With Study Lenses
Visual acuity (VA) was assessed with study lenses in place under high contrast, high illumination. VA was collected for both eyes together 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 wear period. A wear period was approximately 30 days.

Timeline

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

27 May 20221 Sep 2022

First posted21 Apr 2022
Study start27 May 2022
Primary completion1 Sep 2022
Study completion1 Sep 2022

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 PresbyopiaStudies 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: 101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05338333
Sponsor's protocol ID: CLN705-C001
Status last verified: Aug 2023
First submitted: 14 Apr 2022
Last updated: 13 Sep 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
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
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Clinical Trial With Artiflex Presbyopic (Artiplus)
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Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
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Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
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Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
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All Presbyopia trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses
ClinicalTrials.gov ID: NCT05338333
Acronym / sponsor ID: CLN705-C001
Conditions: Presbyopia
Keywords: Contact lenses, Multifocal
Study type: Interventional
Recruitment status: Completed
Enrolment: 101 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 27 May 2022 (actual)
Primary completion: 1 Sep 2022 (actual)
Study completion: 1 Sep 2022 (actual)
First posted: 21 Apr 2022 (actual)
Results: Posted 13 Sep 2023

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: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
LID210464, then AOHG MF	Other	Device: Lehfilcon A multifocal contact lenses, Device: Lotrafilcon B multifocal contact lenses, Device: CLEAR CARE®Lehfilcon A multifocal contact lenses (LID210464) worn in Period 1, with lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 30 days. CLEAR CARE® will be used for nightly contact lens cleaning and disinfecting.
AOHG MF, then LID210464	Other	Device: Lehfilcon A multifocal contact lenses, Device: Lotrafilcon B multifocal contact lenses, Device: CLEAR CARE®Lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 1, with lehfilcon A multifocal contact lenses (LID210464) worn in Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 30 days. CLEAR CARE® will be used for nightly contact lens cleaning and disinfecting.

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Able to understand and sign an informed consent form that has been approved by an Institutional Review Board.
Willing and able to attend all study visits as required by the protocol.
Willing to stop wearing habitual contact lenses for the duration of the study.
Currently wearing daily disposable and biweekly/monthly replacement multifocal soft contact lenses in both eyes at least 5 days per week and at least 8 hours per day for at least 3 months. AOHG MF wearers may be included.
Other protocol-specified inclusion criteria may apply.

Key exclusion criteria (6 listed)

Any eye infection, inflammation, abnormality, or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator.
Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator.
History of refractive surgery or planning to have refractive surgery during the study.
Current or history of pathologically dry eye.
Currently pregnant or lactating.

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 multifocal contact lensesAlso: LID210464Investigational frequent replacement soft contact lens indicated for the optical correction of presbyopia	Device	AOHG MF, then LID210464, LID210464, then AOHG MF
Lotrafilcon B multifocal contact lensesAlso: AOHG MF, AIR OPTIX® plus HydraGlyde® Multifocal (AOHG MF) contact lensesCommercially available frequent replacement soft contact lens indicated for the optical correction of presbyopia	Device	AOHG MF, then LID210464, LID210464, then AOHG MF
CLEAR CARE®Hydrogen peroxide-based contact lens cleaning and disinfecting solution	Device	AOHG MF, then LID210464, LID210464, then AOHG MF

Primary outcome

Least Squares Mean Binocular High Contrast/High Illumination Visual Acuity at Distance With Study Lenses
Time frame: Day 30, each wear period. A wear period was approximately 30 days.
Visual acuity (VA) was assessed with study lenses in place under high contrast, high illumination. VA was collected for both eyes together 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 13 Sep 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
LID210464, Then AOHG MF	51	50
AOHG MF, Then LID210464	50	50

Primary outcome: Least Squares Mean Binocular High Contrast/High Illumination Visual Acuity at Distance With Study Lenses

Time frame: Day 30, each wear period. A wear period was approximately 30 days.. Least squares mean (Standard Error). Unit: logMAR

Measure	LID210464 n = 50	AOHG MF n = 50
Value	-0.10 (0.010)	-0.09 (0.010)

LID210464 vs AOHG MF: Least Squares Mean Difference: -0.01

Population analysed: Full Analysis Set: All randomized subjects/eyes 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 101 (0%)	0 of 101 (0%)	0 of 101
LID210464 Ocular	0 of 202 (0%)	0 of 202 (0%)	0 of 202
LID210464 Non-Ocular	0 of 101 (0%)	0 of 101 (0%)	0 of 101
AOHG MF Ocular	0 of 200 (0%)	0 of 200 (0%)	0 of 200
AOHG MF Non-Ocular	1 of 100 (1%)	0 of 100 (0%)	0 of 100

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Presbyopia

Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
Presbyopia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
Presbyopia
Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
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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

8 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 multifocal contact lenses, Lotrafilcon B multifocal contact lenses and CLEAR CARE® in people with Presbyopia, run by Alcon Research at 8 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 5 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 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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 13 Sep 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 Binocular High Contrast/High Illumination Visual Acuity at Distance With Study Lenses (time frame: Day 30, each wear period. A wear period was approximately 30 days.). 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 NCT05338333.

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 Sep 2023.