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Toric Soft Contact Lenses

T30fA, then Biofinity Toric for Astigmatism

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 between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 30 of each wear period. a wear period is 30 days [-1/+3 days] according to randomization assignment)

Awards & highlights

Study Summary

This trial compares two types of soft contact lenses to see which works better for astigmatism.

Who is the study for?

This trial is for people who have been successfully wearing toric soft contact lenses regularly for at least 3 months, with good vision (20/25 or better). Participants must be willing to follow the study's lens-wearing schedule. Those with certain eye conditions, monovision or multifocal lens users, and wearers of specific brands like Biofinity Toric in the past 3 months cannot join.Check my eligibility

What is being tested?

The study compares two types of monthly replacement toric soft contact lenses: TOTAL30 for Astigmatism (Lehfilcon A) and Biofinity Toric (Comfilcon A). It aims to evaluate their clinical performance when used by individuals with astigmatism.See study design

What are the potential side effects?

Potential side effects may include discomfort while wearing the lenses, dry eyes, redness, reduced visual acuity, or more serious issues such as corneal abrasion or infection. However, these are general risks associated with any contact lens use.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 30 of each wear period. a wear period is 30 days [-1/+3 days] according to randomization assignment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 30 of each wear period. a wear period is 30 days [-1/+3 days] according to randomization assignment)

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Distance VA with study lenses at Day 30

Trial Design

2Treatment groups

Experimental Treatment

Group I: T30fA, then Biofinity ToricExperimental Treatment3 Interventions

Lehfilcon A toric contact lenses worn in Period 1, followed by comfilcon A toric contact lenses worn in Period 2, as randomized. The study lenses will be worn bilaterally (in both eyes) during waking hours for at least 12 hours per day during each wear period (30 days [-1/+3] according to randomization assignment). Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE Cleaning & Disinfecting Solution.

Group II: Biofinity Toric, then T30fAExperimental Treatment3 Interventions

Comfilcon A toric contact lenses worn in Period 1, with lehfilcon A toric contact lenses worn in Period 2, as randomized. The study lenses will be worn bilaterally (in both eyes) during waking hours for at least 12 hours per day during each wear period (30 days [-1/+3] according to randomization assignment). Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE Cleaning & Disinfecting Solution.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lehfilcon A toric contact lenses

2022

N/A

~80

Comfilcon A toric contact lenses

2022

N/A

~80

CLEAR CARE

2022

N/A

~1570

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Alcon ResearchLead Sponsor

704 Previous Clinical Trials

124,444 Total Patients Enrolled

44 Trials studying Astigmatism

8,377 Patients Enrolled for Astigmatism

Clinical Trial Lead, Vision CareStudy DirectorAlcon Research, LLC

20 Previous Clinical Trials

2,897 Total Patients Enrolled

5 Trials studying Astigmatism

429 Patients Enrolled for Astigmatism

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age limit of this research extend beyond 45 years?

"The ideal patient for this trial is within the age range of greater than 18 and less than 45 years old."

Answered by AI

Are participants being enrolled for this research study presently?

"This clinical trial is not accepting participants at this time, as reported on clinicaltrials.gov. The posting for the study was first put up on January 1st 2024 and has been amended most recently December 4th 2023; however, there are 57 other studies that can be applied to right now."

Answered by AI

How many venues have been designated to conduct this trial?

"This trial is available at 5 different centres, including the Kurata Eye Care Center in Los Angeles, ProCare Vision Center in Granville and Vision Health Institute in Orlando. There are also 2 additional sites that participants may attend."

Answered by AI

Do I meet the criteria to be accepted into this medical experiment?

"To qualify for this clinical trial, individuals must possess astigmatism and be between 18 to 45 years old. A total of 66 people are needed as participants in the study."

Answered by AI