Multifocal Toric Contact Lenses for Astigmatism and Presbyopia

No longer recruiting at 10 trial locations

Overseen By Alcon Call Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Alcon Research

Must not be taking: Topical ocular medications

Disqualifiers: Extended wear lenses, Monovision, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the effectiveness of two types of contact lenses for individuals with astigmatism (blurred vision due to an irregularly shaped cornea) and presbyopia (difficulty focusing on close objects with age) over 30 days. Participants will wear each type of lens—Lehfilcon A multifocal for astigmatism and Samfilcon A multifocal for astigmatism—for a month to determine which performs better for daily use. The trial suits those who regularly use multifocal contact lenses, do not sleep in them, and are willing to forgo reading glasses while wearing the trial lenses. Individuals already using these lenses and seeking new options may find this trial beneficial. As an unphased trial, it offers the opportunity to explore new contact lens options without the constraints of a traditional clinical trial phase.

Do I need to stop taking my current medications for the trial?

You will need to stop using any eye drops or medications that you apply directly to your eyes while wearing the study contact lenses.

What prior data suggests that these contact lenses are safe for use in astigmatism and presbyopia?

Research has shown that lehfilcon A contact lenses have FDA approval to assist with presbyopia, a condition causing difficulty in seeing things up close. Most users find them comfortable. However, one study found high levels of certain chemicals in these lenses, and researchers are still assessing their impact on safety.

For samfilcon A contact lenses, studies indicate they effectively focus light on the eye. They are generally safe for daily use, but wearing them overnight increases the risk of serious issues. Smokers may experience more problems with these lenses than non-smokers.

Both types of lenses are designed for daytime wear and should be removed and cleaned daily to minimize risks. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Lehfilcon A and Samfilcon A multifocal contact lenses because they offer innovative solutions for people with both astigmatism and presbyopia. Unlike traditional contact lenses that often address only one of these conditions, these lenses are designed to correct both simultaneously, providing clearer vision at multiple distances. They also incorporate advanced materials that enhance comfort and eye health, making them suitable for extended daily wear. This dual-functionality and enhanced comfort set them apart from the standard single-focus lenses or multifocal lenses not specifically designed for astigmatism.

What evidence suggests that this trial's treatments could be effective for astigmatism and presbyopia?

Research has shown that both lehfilcon A and samfilcon A multifocal contact lenses work well for people with astigmatism and presbyopia. In this trial, participants will wear both types of lenses during different periods. Many users report high satisfaction with lehfilcon A lenses, noting their comfort and clear vision. Samfilcon A lenses feature a special design called OpticAlign and 3-Zone Progressive Design, which helps maintain steady vision and reduces issues like halos and glare, even in dim light. These features make both types of lenses good options for improving vision issues related to astigmatism and presbyopia. ^{1 5 6 7 8}

Who Is on the Research Team?

Sr. Clinical Trial Lead, Vision Care

Principal Investigator

Alcon Research, LLC

Are You a Good Fit for This Trial?

This trial is for individuals with both astigmatism and presbyopia, conditions affecting vision. Participants should require contact lenses that correct for these issues. Specific eligibility details are not provided, but typically participants must be in good general health and have a stable prescription.

Inclusion Criteria

Manifest cylinder equal to or greater than 0.75 diopter (D) in each eye at Screening

Willing to not use readers while wearing study contact lenses for duration of the study

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

Wears 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

Monovision contact lens wearers and wearers of contact lens in one eye only

Other protocol-defined exclusion criteria may apply.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants wear samfilcon A or lehfilcon A multifocal for astigmatism contact lenses for 30 days

4 weeks

2 visits (in-person)

Treatment Period 2

Participants switch to the alternate contact lenses for another 30 days

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Lehfilcon A multifocal for astigmatism contact lenses
• Samfilcon A multifocal for astigmatism contact lenses

Trial Overview The study is testing two types of silicone hydrogel multifocal toric contact lenses designed for people with astigmatism and presbyopia: Lehfilcon A and Samfilcon A. The clinical performance of these lenses will be evaluated after 30 days of wear.

How Is the Trial Designed?

Group I: ULTRA MFfA, then LID230451 Experimental Treatment 3 Interventions

Samfilcon A multifocal for astigmatism contact lenses worn in Period 1, followed by lehfilcon A multifocal for astigmatism contact lenses worn in Period 2, as randomized. The study lenses will be worn bilaterally (in both eyes) during typical contact lens wearing hours for at least 8 hours per day during each wear period \[30 days (-2/+1)\]. Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE.

Group II: LID230451, then ULTRA MFfA Experimental Treatment 3 Interventions

Lehfilcon A multifocal for astigmatism contact lenses worn in Period 1, followed by samfilcon A multifocal for astigmatism contact lenses worn in Period 2, as randomized. The study lenses will be worn bilaterally (in both eyes) during typical contact lens wearing hours for at least 8 hours per day during each wear period \[30 days (-2/+1)\]. Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE.

Who Is Running the Clinical Trial?

Alcon Research

Lead Sponsor

Trials

739

Recruited

128,000+

Raquel C. Bono

Alcon Research

Chief Medical Officer since 2022

MD from Harvard Medical School

David Endicott

Alcon Research

Chief Executive Officer since 2018

MBA from University of Southern California

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11568563/

Subjective Wearing Experience of Lehfilcon A Among ... A high proportion of subjects were satisfied with the subjective wearing experience with lehfilcon A toric lenses, including satisfaction with comfort, visual ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/33/NCT05338333/Prot_000.pdf

Clinical Performance Evaluation of ... Indication for Use. These comparator multifocal soft contact lenses are indicated for the optical correction of presbyopia, with or without refractive ametropia ...

3. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf21/K210436.pdf

K210436 - accessdata.fda.gov TOTAL3OTm for Astigmatism (lehfilcon A) toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39555214/

Subjective Wearing Experience of Lehfilcon A Among ... The results of this study suggest that a high proportion of patients were satisfied with the subjective wearing experience with the new toric ...

5. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05805345

Clinical Comparison of Toric Contact Lenses Fit ... DAILIES TOTAL1® for Astigmatism. Device : Lehfilcon A toric soft contact lens. Commercially available silicone hydrogel contact lens. Other ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/K233856.pdf

K233856.pdf - accessdata.fda.gov TOTAL30 Multifocal (lehfilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia ...

7. glance.eyesoneyecare.com glance.eyesoneyecare.com/stories/2023-05-23/study-identifies-cancer-causing-chemicals-in-popular-contact-lenses/

Study identifies cancer-causing chemicals in popular ... All contact lenses revealed levels of organic fluorine ranging from 105 to 20,700 ppm—far exceeding the highest level standard set by the EPA, ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10507745/

Silicone hydrogel versus hydrogel soft contact lenses for ... For extended wear, hydrogel SCL may have a lower risk of adverse events at 52 weeks compared to silicon hydrogel. Future well‐designed trials are needed to ...