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Contact Lens
Silicone Hydrogel Toric Lenses for Astigmatism
N/A
Waitlist Available
Led By Andrew Sacco
Research Sponsored by Coopervision, Inc.
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 one month wear
Awards & highlights
Study Summary
This trial studies the effectiveness of two 1-month contact lenses for people who regularly use them.
Who is the study for?
This trial is for people aged 18-39 with astigmatism, who need glasses between +8.00 to -10.00D, and wear toric soft contact lenses regularly for at least 8 hours a day, six days a week. Participants should have had an eye exam in the last two years and be able to follow the study schedule.Check my eligibility
What is being tested?
The study compares two types of monthly toric silicone hydrogel contact lenses (Lens A and Lens B) in regular users over one month each to see which performs better in terms of comfort and vision quality.See study design
What are the potential side effects?
While not specified here, typical side effects from wearing contact lenses can include dry eyes, discomfort or irritation, redness, blurry vision, and increased risk of eye infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one month of wear
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one month of wear
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Lens Handling on Removal
Secondary outcome measures
Distance Visual Acuity
Trial Design
2Treatment groups
Experimental Treatment
Group I: Lens B, Then Lens AExperimental Treatment2 Interventions
Participants will wear Lens B for one month and then crossover to Lens A for one month.
Group II: Lens A, Then Lens BExperimental Treatment2 Interventions
Participants will wear Lens A for one month and then crossover to Lens B for one month.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lens B (lehfilcon A toric lens)
2023
N/A
~60
Lens A (comfilcon A toric lens)
2023
N/A
~60
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Who is running the clinical trial?
COREUNKNOWN
10 Previous Clinical Trials
2,235 Total Patients Enrolled
Coopervision, Inc.Lead Sponsor
156 Previous Clinical Trials
13,809 Total Patients Enrolled
32 Trials studying Astigmatism
1,364 Patients Enrolled for Astigmatism
Centre for Ocular Research & Education, CanadaOTHER
10 Previous Clinical Trials
2,235 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have good overall health and can see clearly at a distance with the help of glasses or contact lenses.You can't wear more than 10 Acuvue Oasys for Astigmatism lenses.You have a medical condition that the researchers think could impact the results of the study.You regularly wear toric soft contact lenses in both eyes.You can only use Acuvue Vita for Astigmatism lenses for a maximum of 3 times.You have an eye condition or infection that makes it unsafe for you to wear contact lenses.
Research Study Groups:
This trial has the following groups:- Group 1: Lens A, Then Lens B
- Group 2: Lens B, Then Lens A
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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