Refractive ErrorsNCT05886907

Assessing the Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Toric Contact Lenses

A study testing Lehfilcon A multifocal toric contact lenses, Samfilcon A multifocal toric contact lenses and CLEAR CARE in people with Refractive Errors and Presbyopia, run by Alcon Research at 1 site 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 trial is to assess on-eye performance and overall fit of an investigational multifocal toric contact lens to aid in confirmation of the study lens design. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Refractive Errors, Presbyopia, Astigmatism
What is being tested?: Lehfilcon A multifocal toric contact lenses, Samfilcon A multifocal toric contact lenses and CLEAR CARE
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: 14 Jun 2023to 17 Jul 2023
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

Requires ADD (additional power for near vision);
Currently wears multifocal soft contact lenses in both eyes during the past 3 months;
Manifest cylinder power between -0.75 diopter (D) and -1.00 D;
Best Corrected Visual Acuity (BCVA) of logMAR 0.10 (Snellen 20/25) or better in each eye.
Other protocol-specified inclusion criteria may apply.

Who cannot join

Any anterior segment infection, inflammation, or 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;
Current or history of pathologically dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear;
Monovision contact lens wear.
Other protocol-specified exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

United States1 site

Johns Creek Research Clinic
Johns Creek, Georgia, 30097

Other trials in United States

About this study

The purpose of this clinical trial is to assess on-eye performance and overall fit of an investigational multifocal toric contact lens to aid in confirmation of the study lens design.

Read the detailed description

Subjects will attend 3 study visits with a planned individual duration of participation of up to 10 days.

Conditions: Refractive Errors, Presbyopia, Astigmatism
Being tested: Lehfilcon A multifocal toric contact lenses, Samfilcon A multifocal toric contact lenses, CLEAR CARE
Keywords: Contact Lenses
Medical subject headings: Refractive Errors, Presbyopia, Astigmatism

What participants receive

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

Lehfilcon A multifocal toric contact lensesDevice
Also called LID223188
Investigational silicone hydrogel contact lenses
Samfilcon A multifocal toric contact lensesDevice
Also called Ultra MFT, Bausch + Lomb Ultra® Multifocal for Astigmatism
Commercially available silicone hydrogel contact lenses
CLEAR CAREDevice
Also called CLEAR CARE® Cleaning and Disinfecting Solution
Hydrogen peroxide based contact lens cleaning and disinfecting solution

Study groups in NCT05886907
Study group	Role	What they receive
LID223188, then Ultra MFT	Other	Lehfilcon A multifocal toric contact lenses worn first, with samfilcon A multifocal toric contact lenses worn second. Each product will be worn bilaterally (in both eyes) during waking hours for approximately 2 days. CLEAR CARE will be used for daily contact lens cleaning and disinfection. Receives: Device: Lehfilcon A multifocal toric contact lenses; Device: Samfilcon A multifocal toric contact lenses; Device: CLEAR CARE
Ultra MFT, then LID223188	Other	Samfilcon A multifocal toric contact lenses worn first, with lehfilcon A multifocal toric contact lenses worn second. Each product will be worn bilaterally (in both eyes) during waking hours for approximately 2 days. CLEAR CARE will be used for daily contact lens cleaning and disinfection. Receives: Device: Lehfilcon A multifocal toric contact lenses; Device: Samfilcon A multifocal toric 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 (VA) With Study Lenses
Visual Acuity (VA) was assessed binocularly (both eyes together) with study lenses in place at a distance of 4 meters using letter charts. VA was recorded in logarithm minimum angle of resolution (logMAR), where 0.0 logMAR equates to 20/20 Snellen (normal distance eyesight). A lower number indicates better visual acuity. No hypothesis testing is pre-specified for this endpoint.
Measured: Day 2, each wear period. A wear period was approximately 2 days.

Timeline

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

14 Jun 202317 Jul 2023

First posted2 Jun 2023
Study start14 Jun 2023
Primary completion17 Jul 2023
Study completion17 Jul 2023

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: Non-randomised
Intervention model: Crossover
Model description: Subjects will wear the products (test and comparator) in a predetermined order.
Masking: Single blind
Who is masked: Participant
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05886907
Sponsor's protocol ID: CLR624-M103
Status last verified: Jul 2024
First submitted: 24 May 2023
Last updated: 31 Jul 2024
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
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
Amblyopia
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

All Refractive Errors trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessing the Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Toric Contact Lenses
ClinicalTrials.gov ID: NCT05886907
Acronym / sponsor ID: CLR624-M103
Conditions: Refractive Errors, Presbyopia, Astigmatism
Keywords: Contact Lenses
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 14 Jun 2023 (actual)
Primary completion: 17 Jul 2023 (actual)
Study completion: 17 Jul 2023 (actual)
First posted: 2 Jun 2023 (actual)
Results: Posted 31 Jul 2024

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 clinical trial is to assess on-eye performance and overall fit of an investigational multifocal toric contact lens to aid in confirmation of the study lens design.

Detailed description

Subjects will attend 3 study visits with a planned individual duration of participation of up to 10 days.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2
Model description: Subjects will wear the products (test and comparator) in a predetermined order.

Arm	Type	Receives
LID223188, then Ultra MFT	Other	Device: Lehfilcon A multifocal toric contact lenses, Device: Samfilcon A multifocal toric contact lenses, Device: CLEAR CARELehfilcon A multifocal toric contact lenses worn first, with samfilcon A multifocal toric contact lenses worn second. Each product will be worn bilaterally (in both eyes) during waking hours for approximately 2 days. CLEAR CARE will be used for daily contact lens cleaning and disinfection.
Ultra MFT, then LID223188	Other	Device: Lehfilcon A multifocal toric contact lenses, Device: Samfilcon A multifocal toric contact lenses, Device: CLEAR CARESamfilcon A multifocal toric contact lenses worn first, with lehfilcon A multifocal toric contact lenses worn second. Each product will be worn bilaterally (in both eyes) during waking hours for approximately 2 days. CLEAR CARE will be used for daily contact lens cleaning and disinfection.

Who may qualify

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

Key inclusion criteria (5 listed)

Requires ADD (additional power for near vision);
Currently wears multifocal soft contact lenses in both eyes during the past 3 months;
Manifest cylinder power between -0.75 diopter (D) and -1.00 D;
Best Corrected Visual Acuity (BCVA) of logMAR 0.10 (Snellen 20/25) or better in each eye.
Other protocol-specified inclusion criteria may apply.

Key exclusion criteria (5 listed)

Any anterior segment infection, inflammation, or 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;
Current or history of pathologically dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear;
Monovision contact lens wear.
Other protocol-specified 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 multifocal toric contact lensesAlso: LID223188Investigational silicone hydrogel contact lenses	Device	LID223188, then Ultra MFT, Ultra MFT, then LID223188
Samfilcon A multifocal toric contact lensesAlso: Ultra MFT, Bausch + Lomb Ultra® Multifocal for AstigmatismCommercially available silicone hydrogel contact lenses	Device	LID223188, then Ultra MFT, Ultra MFT, then LID223188
CLEAR CAREAlso: CLEAR CARE® Cleaning and Disinfecting SolutionHydrogen peroxide based contact lens cleaning and disinfecting solution	Device	LID223188, then Ultra MFT, Ultra MFT, then LID223188

Primary outcome

Mean Distance Visual Acuity (VA) With Study Lenses
Time frame: Day 2, each wear period. A wear period was approximately 2 days.
Visual Acuity (VA) was assessed binocularly (both eyes together) with study lenses in place at a distance of 4 meters using letter charts. VA was recorded in logarithm minimum angle of resolution (logMAR), where 0.0 logMAR equates to 20/20 Snellen (normal distance eyesight). A lower number indicates better visual acuity. No hypothesis testing is pre-specified for this endpoint.

Results and safety

Results posted to the registry on 31 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LID223188, Then Ultra MFT	5	5
Ultra MFT, Then LID223188	4	4

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

Time frame: Day 2, each wear period. A wear period was approximately 2 days.. Mean (Standard Deviation). Unit: logMAR

Measure	LID223188 n = 9	Ultra MFT n = 9
Value	-0.04 (0.09)	-0.09 (0.07)

Population analysed: This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study.

Adverse events

Time frame: Adverse Events (AEs) were collected from time of consent to study exit, up to 10 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pretreatment	0 of 9 (0%)	0 of 9 (0%)	0 of 9
LID223188 Ocular	0 of 18 (0%)	0 of 18 (0%)	0 of 18
LID223188 Nonocular	0 of 9 (0%)	0 of 9 (0%)	0 of 9
Ultra MFT Ocular	0 of 18 (0%)	0 of 18 (0%)	0 of 18
Ultra MFT Nonocular	0 of 9 (0%)	0 of 9 (0%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
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.

Clinical Trial Lead, CRD Vision Care study director

Alcon Research, LLC

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

Questions about this trial

What is this clinical trial studying?

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 5 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 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 31 Jul 2024). 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 (VA) With Study Lenses (time frame: Day 2, each wear period. A wear period was approximately 2 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 NCT05886907.

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 31 Jul 2024.