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Contact Lens
Multifocal Toric Contact Lenses for Astigmatism and Presbyopia
N/A
Recruiting
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
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.]
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Binocular visual acuity at distance (4 meters) at Day 30 with study lenses
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
~1630
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Who is running the clinical trial?
Alcon ResearchLead Sponsor
724 Previous Clinical Trials
128,271 Total Patients Enrolled
48 Trials studying Astigmatism
9,004 Patients Enrolled for Astigmatism
Sr. Clinical Trial Lead, Vision CareStudy DirectorAlcon Research, LLC
3 Previous Clinical Trials
434 Total Patients Enrolled
1 Trials studying Astigmatism
153 Patients Enrolled for Astigmatism
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