Refractive AmetropiaNCT05765227

Clinical Evaluation of a Manufacturing Process for a Frequent Replacement Silicone Hydrogel Multifocal Contact Lens

A study testing Lehfilcon A multifocal contact lenses, Lotrafilcon B multifocal contact lenses and Hydrogen peroxide-based cleaning and disinfection system in people with Refractive Ametropia, 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

Search all trials

Trial summary

The purpose of this clinical trial was to evaluate the clinical performance of a manufacturing process on a frequent replacement multifocal contact lens. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Refractive Ametropia
What is being tested?: Lehfilcon A multifocal contact lenses, Lotrafilcon B multifocal contact lenses and Hydrogen peroxide-based cleaning and disinfection system
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: 8 Mar 2023to 30 Mar 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

Able to understand and sign an consent form (ICF) that has been approved by an Institutional Review Board (IRB);
Willing to stop wearing habitual contact lenses for the duration of study participation;
Currently wearing multifocal soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
Other protocol-defined inclusion criteria may apply.

Who cannot join

Any eye 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;
History of refractive surgery, or plan to have refractive surgery during the study;
Current or history of dry eye in either eye that would preclude contact lens wear, in the opinion of the investigator;
Monovision contact lens wear;
Other protocol-defined 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 was to evaluate the clinical performance of a manufacturing process on a frequent replacement multifocal contact lens.

Read the detailed description

Subjects will be expected to attend 3 scheduled visits. Eligible subjects will wear each study lens type in a cross-over fashion for approximately 2 days.

Conditions: Refractive Ametropia
Being tested: Lehfilcon A multifocal contact lenses, Lotrafilcon B multifocal contact lenses, Hydrogen peroxide-based cleaning and disinfection system
Keywords: Presbyopia
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 LID#224381 MF contact lenses
Investigational silicone hydrogel multifocal contact lenses
Lotrafilcon B multifocal contact lensesDevice
Also called AOHG MF contact lenses, AIR OPTIX® plus HydraGlyde ® multifocal contact lenses (AOHG MF)
Commercially available silicone hydrogel multifocal contact lenses
Hydrogen peroxide-based cleaning and disinfection systemDevice
Also called CLEAR CARE®
Commercially available cleaning and disinfection system for silicone hydrogel contact lenses

Study groups in NCT05765227
Study group	Role	What they receive
LID#224381, then AOHG MF	Other	Lehfilcon A multifocal contact lenses worn first, with lotrafilcon B multifocal contact lenses worn second in pre-determined order. Each study lens type will be worn bilaterally (in both eyes) for approximately 2 days. CLEAR CARE will be used for nightly cleaning and disinfection. Receives: Device: Lehfilcon A multifocal contact lenses; Device: Lotrafilcon B multifocal contact lenses; Device: Hydrogen peroxide-based cleaning and disinfection system
AOHG MF, then LID#224381	Other	Lotrafilcon B multifocal contact lenses worn first, with lehfilcon A multifocal contact lenses worn second in pre-determined order. Each study lens type will be worn bilaterally (in both eyes) for approximately 2 days. CLEAR CARE will be used for nightly cleaning and disinfection. Receives: Device: Lehfilcon A multifocal contact lenses; Device: Lotrafilcon B multifocal contact lenses; Device: Hydrogen peroxide-based cleaning and disinfection system

What is being measured

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

Binocular Visual Acuity (VA) With Study Lenses at 4 Meters (logMAR)
VA was assessed binocularly (both eyes together) using a letter chart and measured in 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. No hypothesis testing was prespecified for this endpoint.
Measured: Day 2, each study lens type worn during the corresponding crossover period

Timeline

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

8 Mar 202330 Mar 2023

First posted13 Mar 2023
Study start8 Mar 2023
Primary completion30 Mar 2023
Study completion30 Mar 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 AmetropiaStudies 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
Masking: Single blind
Who is masked: Participant
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05765227
Sponsor's protocol ID: CLN705-M103
Status last verified: Mar 2024
First submitted: 1 Mar 2023
Last updated: 16 Apr 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

Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Not yet recruiting
Comparison of Two Rotational Alignment Methods for Astigmatism Correction in SMILE Surgery
Myopia, Refractive Ametropia
Recruiting
The Impact of 'A Miss Is as Good as a Mile': Is Compensation Necessary for Minimal Ocular Deviation in Myopic Laser Surgery?
Myopia, Refractive Ametropia
Recruiting
Comparison of Low- Versus High-Level Angle Kappa Compensation Strategies in SMILE Using the VisuMax 800: A Randomized Clinical Trial
Myopia, Refractive Ametropia
Recruiting
A Study to Evaluate the Clinical Performance and Safety of UNICON Silicone Hydrogel Daily Disposable Soft Contact Lenses
Refractive Ametropia

All Refractive Ametropia trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of a Manufacturing Process for a Frequent Replacement Silicone Hydrogel Multifocal Contact Lens
ClinicalTrials.gov ID: NCT05765227
Acronym / sponsor ID: CLN705-M103
Conditions: Refractive Ametropia
Keywords: Presbyopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 8 Mar 2023 (actual)
Primary completion: 30 Mar 2023 (actual)
Study completion: 30 Mar 2023 (actual)
First posted: 13 Mar 2023 (actual)
Results: Posted 16 Apr 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 was to evaluate the clinical performance of a manufacturing process on a frequent replacement multifocal contact lens.

Detailed description

Subjects will be expected to attend 3 scheduled visits. Eligible subjects will wear each study lens type in a cross-over fashion for approximately 2 days.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
LID#224381, then AOHG MF	Other	Device: Lehfilcon A multifocal contact lenses, Device: Lotrafilcon B multifocal contact lenses, Device: Hydrogen peroxide-based cleaning and disinfection systemLehfilcon A multifocal contact lenses worn first, with lotrafilcon B multifocal contact lenses worn second in pre-determined order. Each study lens type will be worn bilaterally (in both eyes) for approximately 2 days. CLEAR CARE will be used for nightly cleaning and disinfection.
AOHG MF, then LID#224381	Other	Device: Lehfilcon A multifocal contact lenses, Device: Lotrafilcon B multifocal contact lenses, Device: Hydrogen peroxide-based cleaning and disinfection systemLotrafilcon B multifocal contact lenses worn first, with lehfilcon A multifocal contact lenses worn second in pre-determined order. Each study lens type will be worn bilaterally (in both eyes) for approximately 2 days. CLEAR CARE will be used for nightly 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 (4 listed)

Able to understand and sign an consent form (ICF) that has been approved by an Institutional Review Board (IRB);
Willing to stop wearing habitual contact lenses for the duration of study participation;
Currently wearing multifocal soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
Other protocol-defined inclusion criteria may apply.

Key exclusion criteria (6 listed)

Any eye 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;
History of refractive surgery, or plan to have refractive surgery during the study;
Current or history of dry eye in either eye that would preclude contact lens wear, in the opinion of the investigator;
Monovision contact lens wear;

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: LID#224381 MF contact lensesInvestigational silicone hydrogel multifocal contact lenses	Device	AOHG MF, then LID#224381, LID#224381, then AOHG MF
Lotrafilcon B multifocal contact lensesAlso: AOHG MF contact lenses, AIR OPTIX® plus HydraGlyde ® multifocal contact lenses (AOHG MF)Commercially available silicone hydrogel multifocal contact lenses	Device	AOHG MF, then LID#224381, LID#224381, then AOHG MF
Hydrogen peroxide-based cleaning and disinfection systemAlso: CLEAR CARE®Commercially available cleaning and disinfection system for silicone hydrogel contact lenses	Device	AOHG MF, then LID#224381, LID#224381, then AOHG MF

Primary outcome

Binocular Visual Acuity (VA) With Study Lenses at 4 Meters (logMAR)
Time frame: Day 2, each study lens type worn during the corresponding crossover period
VA was assessed binocularly (both eyes together) using a letter chart and measured in 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. No hypothesis testing was prespecified for this endpoint.

Results and safety

Results posted to the registry on 16 Apr 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
LID#224381, Then AOHG MF	8	8
AOHG MF, Then LID#224381	9	9

Primary outcome: Binocular Visual Acuity (VA) With Study Lenses at 4 Meters (logMAR)

Time frame: Day 2, each study lens type worn during the corresponding crossover period. Mean (Standard Deviation). Unit: logMAR

Measure	LID#224381 n = 17	AOHG MF n = 17
Value	-0.08 (0.06)	-0.06 (0.06)

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 17 (0%)	0 of 17 (0%)	0 of 17
LID#224381 Ocular	0 of 34 (0%)	0 of 34 (0%)	0 of 34
LID#224381 Nonocular	0 of 17 (0%)	0 of 17 (0%)	0 of 17
AOHG MF Ocular	0 of 34 (0%)	0 of 34 (0%)	0 of 34
AOHG MF Nonocular	0 of 17 (0%)	0 of 17 (0%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Refractive Ametropia

Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Not yet recruiting
Comparison of Two Rotational Alignment Methods for Astigmatism Correction in SMILE Surgery
Myopia, Refractive Ametropia
Recruiting
The Impact of 'A Miss Is as Good as a Mile': Is Compensation Necessary for Minimal Ocular Deviation in Myopic Laser Surgery?
Myopia, Refractive Ametropia
Recruiting
Comparison of Low- Versus High-Level Angle Kappa Compensation Strategies in SMILE Using the VisuMax 800: A Randomized Clinical Trial
Myopia, Refractive Ametropia
Recruiting
A Study to Evaluate the Clinical Performance and Safety of UNICON Silicone Hydrogel Daily Disposable Soft Contact Lenses
Refractive Ametropia

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

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 4 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 16 Apr 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 16 Apr 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?

Binocular Visual Acuity (VA) With Study Lenses at 4 Meters (logMAR) (time frame: Day 2, each study lens type worn during the corresponding crossover period). 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 NCT05765227.

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 16 Apr 2024.