RecruitingNAINTERVENTIONAL

MiSight 1 Day Safety Post-Approval Study

This study is looking into the safety of a specific type of daily disposable contact lens called MiSight 1 Day. These lenses are designed for children aged 8 to 12 years old who are short-sighted (have myopia). Doctors in the US have approved these lenses, and this study aims to collect more information to confirm they are safe for children to wear in real-world situations. Researchers will ask children who are already getting these lenses if they'd like to take part. The study will confirm that wearing these lenses daily doesn't cause any unexpected problems for children who meet certain health requirements. It’s important because ensuring safety is a continuous process for new medical products.

At a glance

Status

Recruiting

Phase

Sponsor

CooperVision, Inc.

Enrolment target

2,400

Start

15 Aug 2022

Estimated completion

30 May 2027

Myopia

What is this study about?

This study is a safety check on a special contact lens called MiSight 1 Day. This lens is designed for children aged 8 to 12 years old who are short-sighted. Short-sightedness means things far away look blurry. These contact lenses are daily disposable, meaning you throw them away at the end of each day and use a fresh pair the next.

Even though these lenses are already approved for use, this study wants to make absolutely sure they are safe when used by many children in everyday life. Think of it as an extra reassurance. Researchers will ask children who fit certain health criteria and are already being fitted with these lenses if they want to participate. They will then keep an eye on these children to make sure the lenses continue to be safe.

The main goal is to gather more information about safety. This helps make sure that the lenses are not only good for improving vision but also completely safe for children to wear over time. It helps doctors and parents feel confident about using this treatment for short-sightedness.

Key takeaways

This study is confirming the safety of daily contact lenses (MiSight 1 Day) for children.
It's for children aged 8-12 who are short-sighted and already use these lenses.
Participation means sharing health data from your child's regular eye check-ups.
The goal is to ensure the lenses are safe for long-term use in everyday situations.
You can withdraw your child from the study at any time without affecting their care.

Who may be eligible?

This study is for children aged between 8 and 12 years old. To join, a child needs to be short-sighted, with a prescription for glasses or contacts between -0.50 and -7.00. They also need to have good vision, meaning they can see at least 20/25 with their best correction, and have healthy eyes without any scratches, infections, or other issues.

There are also some important points for the parents or guardians. You must understand what the study involves and agree to your child's health information being used for the study, while keeping their identity private. Your child also needs to be interested in wearing contact lenses for about 10 hours a day, 6 days a week, and they must have a pair of glasses that they can use and see well with.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child aged 8-12 years old?
Does your child have short-sightedness between -0.50 and -7.00?
Does your child have generally healthy eyes without serious conditions?
Is your child interested in wearing contact lenses for most of the day, 6 days a week?
Do you, as their parent/guardian, understand and agree to share their health data (anonymously) for the study?

Answer every question to see your result.

What does participation involve?

If your child chooses to take part, they will already be receiving MiSight 1 Day contact lenses as part of their regular eye care. The study will involve collecting information about your child's eye health while they are wearing these lenses. This includes checking for any problems or discomfort. The research team will also use existing safety information from another study involving these lenses to help understand the overall safety picture. You and your child will be asked to follow the instructions for wearing and looking after the lenses, and the total duration isn't specified but will likely involve regular check-ups as part of their normal contact lens care.

Potential risks and benefits

The potential benefit of participating is contributing to a better understanding of the MiSight 1 Day lens's safety, which helps other children. The lenses themselves aim to correct short-sightedness. Potential risks with contact lenses generally include eye irritation, dryness, or, rarely, more serious eye infections if not cared for properly. Your child will already be using these lenses, so any risks are those normally associated with wearing contact lenses. You and your child have the right to withdraw from the study at any time without affecting your child's ongoing medical care.

Locations (50)

Experts on Sight LLC.
Verified postcode
Gilbert, United States· Recruiting
Centerton Family Eyecare
Verified postcode
Centerton, United States· Recruiting
University of California, Berkeley University Eye Center
Verified postcode
Berkeley, United States· Recruiting
Golden Vision Cupertino Optometry
Verified postcode
Cupertino, United States· Recruiting
Boghossian Vision
Verified postcode
Danville, United States· Recruiting
Iron Horse Optometric Group
Verified postcode
Dublin, United States· Recruiting
Capitol Eye Care Center Optometry
Verified postcode
Fremont, United States· Recruiting
Irvine Eye Physicians and Surgeons Inc
Verified postcode
Irvine, United States· Recruiting
Elsa Pao OD, Inc
Verified postcode
Oakland, United States· Recruiting
Perfect Pair Optometry
Verified postcode
San Jose, United States· Recruiting
Almaden Family Optometric Center
Verified postcode
San Jose, United States· Recruiting
Children's Eye Physicians
Verified postcode
Centennial, United States· Recruiting

Common questions

What is myopia?

Myopia is the medical term for short-sightedness, where distant objects appear blurry.

What are MiSight 1 Day lenses?

They are special contact lenses that children wear for one day and then throw away. They are designed to help with short-sightedness.

Will my child receive new treatment in this study?

No, your child would already be using MiSight 1 Day lenses. This study just observes their safety in children already prescribed the lenses.

Is this study safe for my child?

The study aims to confirm the ongoing safety of lenses that are already approved for use. Researchers will closely monitor participants.

Do I have to do anything extra beyond normal eye care?

The study mostly involves collecting information during your child's regular contact lens appointments. You'll need to agree to share your child's health data for the study.

How to find out more

Kathryn Richdale, OD, PhD

misight.safetypas@coopervision.com 917-755-4548 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.