Multifocal Toric Contact Lenses for Astigmatism and Presbyopia

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

88 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate on-eye clinical performance of the investigational contact lenses following 30 days of wear in the intended population.

Research Team

Sr. Clinical Trial Lead, Vision Care

Principal Investigator

Alcon Research, LLC

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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