← Back to Search

Contact Lens

Multifocal Toric Contact Lenses for Astigmatism and Presbyopia

N/A

Waitlist Available

Research Sponsored by Alcon Research

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 30 (-2/+1) of each wear period. a wear period is 30 days (-2/+1) according to randomization assignment.]

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to assess how well the new contact lenses work when worn for 30 days by the people they are meant for.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the side effects are not listed, common ones associated with wearing contact lenses may include eye discomfort, dryness, redness, blurred vision, tearing up or infection.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I use eye drops or artificial tears with my contact lenses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 30 (-2/+1) of each wear period. a wear period is 30 days (-2/+1) according to randomization assignment.]

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 30 (-2/+1) of each wear period. a wear period is 30 days (-2/+1) according to randomization assignment.]

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 30 (-2/+1) of each wear period. a wear period is 30 days (-2/+1) according to randomization assignment.] for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Binocular visual acuity at distance (4 meters) at Day 30 with study lenses

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: ULTRA MFfA, then LID230451Experimental Treatment3 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 MFfAExperimental Treatment3 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CLEAR CARE

2022

N/A

~1650

0 / 1Eligibility criteria met