Atropine vs MiSight Contact Lenses for Near-Sightedness

Overseen By Hanta Ralay Ranaivo, PhD

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Must not be taking: Antimuscarinics, Bifocals, OrthoK, others

Disqualifiers: Strabismus, Amblyopia, Nystagmus, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

348 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods to manage near-sightedness (myopia) in children: a daily drop of atropine eye drops and MiSight contact lenses. Researchers aim to understand how these treatments affect myopia progression in kids. Children aged 5 to 12 with untreated myopia, without prior use of special glasses or contact lenses, may qualify for this study. This research could identify better ways to slow myopia in children, improving their vision over time. As a Phase 2 trial, the study measures the effectiveness of these treatments in an initial, smaller group of children.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using any form of myopia control or certain contact lenses, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that low-dose atropine eye drops (0.01% to 0.05%) are usually safe for children, with studies finding only minor side effects over three years in kids aged 4 to 12. This makes atropine a promising choice for slowing the progression of nearsightedness in children.

MiSight contact lenses, specially designed to control nearsightedness, have received FDA approval for kids aged 8-12. Research indicates these lenses can reduce the progression of nearsightedness by about 59%. Most children using MiSight lenses experienced positive outcomes, with 90% showing slower worsening of their vision.

Both atropine eye drops and MiSight contact lenses have proven safe and effective for managing nearsightedness in children. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for near-sightedness because they offer novel, potentially more effective options compared to traditional glasses or standard contact lenses. Atropine is unique because it is administered as an eye drop and works by slowing the progression of myopia by relaxing the eye's focusing muscle, which is different from most treatments that only correct vision. MiSight contact lenses are distinct because they're specifically designed to slow myopia progression while correcting vision, using a special optical design that reduces eye strain. Both treatments aim to address the root of the condition, not just the symptoms, offering hope for better long-term outcomes.

What evidence suggests that this trial's treatments could be effective for near-sightedness?

This trial will compare the effectiveness of atropine eye drops and MiSight contact lenses in slowing nearsightedness in children. Research has shown that atropine drops with a 0.05% concentration significantly reduce eye growth over two years, outperforming weaker versions. Studies indicate that this treatment can delay the onset of nearsightedness and maintain stable results over time. Meanwhile, MiSight contact lenses have slowed nearsightedness by 59% over three years, with many children experiencing no worsening. Both treatments, tested in separate arms of this trial, offer promising ways to manage nearsightedness in children. ^{2 6 7 8 9}

Who Is on the Research Team?

Magdalena Stec, OD

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Are You a Good Fit for This Trial?

This trial is for children aged 5-12 with mild to high near-sightedness, weighing over 1500g at birth and born after at least 32 weeks of gestation. It excludes those with certain eye abnormalities, previous myopia treatments, systemic conditions affecting the eyes, or a history of eye surgeries.

Inclusion Criteria

Gestational age ≥ 32 weeks

Birth weight >1500g

I am between 5 and 12 years old.

Exclusion Criteria

Current or previous form of myopia control

Down syndrome or cerebral palsy

I have been treated for nearsightedness with specific eye drops.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 0.05% atropine drops or MiSight contact lenses for myopia control

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Atropine
• MiSight contact lenses

Trial Overview

The study compares two methods to control myopia in kids: Atropine drops versus MiSight contact lenses. The goal is to understand how these treatments affect the development and progression of near-sightedness in young eyes.

How Is the Trial Designed?

Group I: MiSight contact lenses Experimental Treatment 1 Intervention

MiSight contact lenses. Daily wear for 2 years.

Group II: Atropine Experimental Treatment 1 Intervention

0.05% atropine. One drop per eye per day for 2 years.

Group III: Observation Active Control 1 Intervention

No treatment.

Atropine is already approved in United States, Canada for the following indications:

Approved in United States as Atropine for:

• Uveitis
• Pupillary dilation
• Refraction assessment
• Amblyopia
• Cycloplegia

Approved in Canada as Atropine for:

• Uveitis
• Pupillary dilation
• Refraction assessment
• Amblyopia
• Cycloplegia

Who Is Running the Clinical Trial?

Ann & Robert H Lurie Children's Hospital of Chicago

Lead Sponsor

Trials

275

Recruited

5,182,000+

Published Research Related to This Trial

The MOSAIC trial is a double-masked, placebo-controlled study involving 250 children aged 6-16 years, investigating the efficacy and safety of 0.01% unpreserved atropine for controlling myopia progression over 24 months.

This study is significant as it is the first randomized clinical trial to assess atropine's effects in a predominantly White population, addressing the limitations of previous studies that primarily included Asian participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Myopia Outcome Study of Atropine in Children (MOSAIC): an investigator-led, double-masked, placebo-controlled, randomised clinical trial protocol. McCrann, S., Flitcroft, I., Strang, NC., et al.[2021]

The study evaluated a combination of cyclopentolate and tropicamide (CTA) for cycloplegia in 33 black children, finding it to provide reliable refractive results similar to atropine, which is the gold standard.

While atropine is more effective, the CTA combination is less disabling and offers a satisfactory alternative for routine use in children, making it a practical option for objective refraction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Objective refraction in black children: cyclopentolate and tropicamide combination, a reliable alternative to atropine?]. Ka, AM., De Medeiros, ME., Sow, AS., et al.[2022]

A retrospective study of 79 patients over ten years found that atropine eyedrops can effectively manage myopia, especially in children with low refractive errors, who are more likely to benefit from the treatment.

Children who responded well to atropine in the first year tended to continue treatment, while those with less favorable results often stopped, indicating the importance of early response in treatment adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Further observations on use of atropine in the treatment of myopia. Brenner, RL.[2013]

The study investigated how different drugs, including atropine and gentamicin, are absorbed and released in soft contact lenses with varying hydrophilic properties and thicknesses, using radiometry to measure these kinetics.

Factors such as the chemical structure of the drug, the hydrophilic nature of the contact lenses, and the temperature of the solution significantly influenced the absorption and desorption rates of the drugs in the lenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Drug kinetics in soft contact lenses. I. In vitro studies]. Rybakova, EG., Avetisov, SE., Badun, GA., et al.[2014]

Cyclopentolate demonstrated the least residual accommodation (1.48 D) compared to homatropine (2.32 D) and atropine (1.10 D), indicating it may provide a more effective cycloplegic effect for eye examinations.

The study suggests that cyclopentolate could be recommended as a routine cycloplegic agent in children due to its favorable balance of efficacy and safety, as evidenced by the measured differences in retinoscopy readings among the three agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Status of cyclopentolate as a cycloplegic in children: a comparison with atropine and homatropine. Khurana, AK., Ahluwalia, BK., Rajan, C.[2019]

In a study involving 97 Danish children aged 6 to 12, low-dose atropine eye drops (0.1% and 0.01%) were found to be safe over a 12-month period, with most reported adverse events being mild.

The treatment showed a modest reduction in myopia progression, with the 0.1% group experiencing 0.24 D less progression in spherical equivalent refraction compared to placebo, although this result was not statistically significant after adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of 0.01% and 0.1% low-dose atropine eye drop regimens for reduction of myopia progression in Danish children: a randomized clinical trial examining one-year effect and safety. Hansen, NC., Hvid-Hansen, A., Møller, F., et al.[2023]

Atropine, particularly at a concentration of 0.05%, is effective in slowing the progression of myopia and controlling axial length growth, which can help prevent serious eye conditions.

The treatment is generally safe and well-tolerated, but it requires long-term use, potentially extending into adolescence, to maintain its benefits and manage the rebound effect after stopping treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low concentration atropine and myopia: a narrative review of the evidence for United Kingdom based practitioners. Jawaid, I., Saunders, K., Hammond, CJ., et al.[2023]

A case report highlighted that the use of Lameline suppositories, which contain atropine derivatives, led to prolonged non-reactive dilation of the pupils (mydriasis) and cycloplegia, indicating potential ocular sensitivity in some individuals.

This case emphasizes the importance of recognizing the presence of atropine derivatives in medications and adhering to contraindications, even at low doses, to prevent adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prolonged mydriasis caused by Lamaline]. Maizoub, S., Autret, E., Furet, Y., et al.[2013]

In a study involving 438 children aged 4 to 12, low-concentration atropine eye drops (0.05%, 0.025%, and 0.01%) significantly reduced myopia progression compared to placebo over one year, with the 0.05% concentration being the most effective.

All concentrations of atropine were well tolerated and did not negatively impact visual acuity or quality of life, indicating a safe option for managing myopia in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-Concentration Atropine for Myopia Progression (LAMP) Study: A Randomized, Double-Blinded, Placebo-Controlled Trial of 0.05%, 0.025%, and 0.01% Atropine Eye Drops in Myopia Control. Yam, JC., Jiang, Y., Tang, SM., et al.[2022]

The combination of 0.05% atropine eye drops with MiSight® 1 day contact lenses effectively reduced myopia progression in four children, decreasing their average myopia change from -1.45 D to -0.41 D over one year.

This case series, involving children with an average age of 9.68 years, is the first to demonstrate the efficacy of this combination treatment in controlling moderate myopia progression, with no reported adverse reactions during the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Rapid Progression of Myopia: Case Series and Literature Review. Erdinest, N., London, N., Levinger, N., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11683068/

Effectiveness of various atropine concentrations in myopia ...

1% atropine demonstrated the highest efficacy in myopia control among East, South and Southeast Asian children, its use is not recommended due to increased ...

2.

jamanetwork.com

jamanetwork.com/journals/jamaophthalmology/fullarticle/2828468

Efficacy and Safety of Different Atropine Regimens for the ...

The group receiving nightly 0.05% atropine eye drops exhibited less 12-month axial eye growth than participants switched from nightly 0.01% ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2162098924001427

Low-concentration atropine for controlling myopia onset ...

Thus, the data revealed that 0.05 % atropine consistently outperformed 0.025 % and 0.01 % concentrations, with efficacy remaining stable over the two-year ...

4.

aaojournal.org

aaojournal.org/article/S0161-6420%252815%252900675-2/fulltext

Five-Year Clinical Trial on Atropine for the Treatment of ...

Over 5 years, atropine 0.01% eyedrops were more effective in slowing myopia progression with less visual side effects compared with higher doses of atropine.

5.

aoa.org

aoa.org/news/clinical-eye-care/public-health/myopia-drops

Study: Could atropine delay or prevent myopia in children?

“The LAMP2 study provides the strongest evidence to date that daily administration of 0.05% atropine delays the onset of myopia and meaningfully ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9522992/

Role of Atropine in the control of Myopia Progression

Over an 18-month treatment period, the atropine-treated group recorded a mean increase in myopia of 0.42 D, which was significantly lower than the changes of ...

7.

myopiaprofile.com

myopiaprofile.com/articles/latest-research-atropine-efficacy-safety-NVK002

The latest research on atropine: efficacy, ideal candidates, ...

While atropine remains as an off-label intervention for myopia management, the CHAMP trial indicates that the novel formulation NVK002 is safe, ...

8.

myopia.worldcouncilofoptometry.info

myopia.worldcouncilofoptometry.info/multimedia-resources/myopia-management-perspectives-atropine/

Myopia Management Perspectives Atropine

The study found that both concentrations significantly slowed myopia progression; interestingly, the 0.01% concentration demonstrated superior efficacy in ...

9.

mykidsvision.org

mykidsvision.org/knowledge-centre/atropine-eye-drops-for-myopia-control-in-children

Atropine eye drops for myopia control in children

Atropine 0.01% to 0.05% has been shown to have minimal side effects in children who were 4 to 12 years of age at the start of treatment.6 This three year study ...