Multifocal Toric Contact Lenses for Astigmatism and Presbyopia
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.12345Why 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.15678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Period 1
Participants wear samfilcon A or lehfilcon A multifocal for astigmatism contact lenses for 30 days
Treatment Period 2
Participants switch to the alternate contact lenses for another 30 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
2
Treatment groups
Experimental Treatment
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alcon Research
Lead Sponsor
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
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 ...
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 ...
K210436 - accessdata.fda.gov
TOTAL3OTm for Astigmatism (lehfilcon A) toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and ...
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 ...
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 ...
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, ...
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 ...
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