What side effects are associated with this type of intervention?

The most common treatments for near-sightedness, such as the MiSight 1 Day lens, can cause side effects like dry eyes, discomfort, and an increased risk of eye infections. Other myopia control methods, such as orthokeratology, may lead to corneal staining and infections, while atropine eye drops can cause light sensitivity and difficulty focusing on near objects.

What prior FDA approvals exist?

The FDA has approved several treatments for near-sightedness (myopia) that correct vision and may slow its progression. One notable example is the MiSight 1 Day lens, a daily disposable contact lens specifically designed for children to both correct vision and slow the progression of myopia. Other similar treatments include orthokeratology (Ortho-K) lenses, which are worn overnight to temporarily reshape the cornea and reduce myopia, and low-dose atropine eye drops, which have been shown to slow the progression of myopia in children.

What other types of research exist?

Promising alternatives to MiSight 1 Day lenses for myopia treatment in 2024 include: 1) Orthokeratology (Ortho-K) lenses, which temporarily reshape the cornea to reduce myopia progression. 2) Atropine eye drops, which have shown efficacy in slowing myopia progression. 3) New multifocal soft contact lenses designed to reduce myopia progression. 4) Advanced spectacle lenses with myopia control designs. 5) Surgical options like intracorneal ring segments and refractive surgery for eligible patients.

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Contact Lens

MiSight 1 Day Contact Lenses for Nearsightedness

N/A

Recruiting

Led By William Gleason, OD

Research Sponsored by Coopervision, Inc.

Eligibility Criteria Checklist

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

Must have

Free of ocular disease or abnormalities (including any corneal scar)

Be between 8 and 12 years of age inclusive at the time of enrollment

Must not have

Use of any systemic or topical ocular medications or over-the-counter artificial tears which might interfere with contact lens wear, pupil size, accommodation or refractive state, or require the lenses to be removed during the day

Has any of the following specific contraindications to MiSight 1 Day lenses at Baseline Visit: Acute and subacute inflammation or infection of the anterior chamber of the eye, Any eye disease, injury, or abnormality that affects the cornea, conjunctiva, or eyelids, Severe insufficiency of lacrimal secretion (dry eyes), Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic, Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses, Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions, Any active corneal infection (bacterial, fungal, or viral), If eyes are red or irritated, The patient is unable to follow lens handling and wear regimen or unable to obtain assistance to do so

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing special contact lenses called MiSight 1 Day to see if they can slow down worsening nearsightedness in children. The study will also check if the benefits last after stopping the treatment. The lenses work by changing how light enters the eye to slow down eye growth. MiSight 1 Day contact lenses have been shown to slow myopia progression in children over several years.

Who is the study for?

This trial is for children aged 8-12 with near-sightedness, having a specific range of vision error and good overall health. They must be willing to wear contact lenses daily for about 10 hours, follow the study's schedule for 4 years, and not have any eye diseases or conditions that could interfere with contact lens use.

What is being tested?

The MiSight 1 Day contact lens is being tested against Proclear 1 day lenses to confirm its effectiveness in reducing myopia in kids when used in everyday life. The study will monitor changes over one year post-treatment.

What are the potential side effects?

While not explicitly listed, potential side effects may include discomfort while wearing the lenses, redness or irritation of the eyes, dry eyes, allergic reactions to lens material or solutions used with them.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My eyes are healthy and free from any diseases or scars.

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I am between 8 and 12 years old.

Exclusion Criteria

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

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I don't use eye medications or artificial tears that affect wearing contact lenses.

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I do not have eye infections, diseases, severe dry eyes, or allergies that contact lenses could worsen.

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I have a history of eye conditions or allergies that could be worsened by contact lenses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Mean difference in axial length change from baseline

Mean difference in cycloplegic SERE change from baseline

Mean difference in rate of axial length - Part 2 study

+1 more

Secondary study objectives

Percentage of subjects with no appreciable myopic progression

Visual symptoms and the effects on activities of daily living

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

Active Control

Group I: MiSight 1 dayExperimental Treatment1 Intervention

MiSight 1 day

Group II: Proclear 1 dayActive Control1 Intervention

Proclear 1 day

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for near-sightedness (myopia) include corrective lenses (glasses and contact lenses), orthokeratology (ortho-k), and pharmacological interventions such as atropine eye drops. Corrective lenses, like the MiSight 1 Day lens, work by refocusing light directly onto the retina, thereby improving vision clarity. Additionally, the MiSight 1 Day lens is designed to create a specific optical profile that reduces the stimulus for eye elongation, potentially slowing the progression of myopia. Orthokeratology involves wearing specially designed rigid contact lenses overnight to temporarily reshape the cornea, improving vision during the day without the need for glasses or contact lenses. Atropine eye drops are used to dilate the pupil and relax the eye's focusing mechanism, which has been shown to slow the progression of myopia in children. These treatments are crucial for myopia patients as they not only correct vision but also address the underlying progression of the condition, reducing the risk of future complications such as retinal detachment and glaucoma.