Atropine vs MiSight Contact Lenses for Near-Sightedness

Recruiting in Palo Alto (17 mi)

Overseen by Magdalena Stec, OD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

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

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing eye drops and special glasses or contact lenses to see if they can slow down worsening nearsightedness in children by controlling eye growth and changing how light enters the eye.

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.

What data supports the effectiveness of the treatment for near-sightedness?

Research shows that using 0.05% atropine eye drops combined with MiSight contact lenses can significantly slow down the progression of near-sightedness in children. In a study, this combination reduced the average myopia progression from -1.45 to -0.41 over one year, indicating its effectiveness in controlling myopia. ^{1 2 3 4 5}

Is the combination of atropine and MiSight contact lenses safe for treating near-sightedness?

Research shows that using low-concentration atropine and MiSight contact lenses is generally safe for children with near-sightedness. Studies have monitored children for adverse reactions and found no significant safety concerns over a year of treatment. ^{1 4 6 7 8}

How does the treatment of atropine and MiSight contact lenses for near-sightedness differ from other treatments?

The combination of 0.05% atropine eye drops and MiSight contact lenses is unique because it targets myopia (near-sightedness) progression by using both a pharmacological approach and a specialized contact lens that alters how light focuses on the retina. This dual approach has shown effectiveness in significantly slowing myopia progression in children, which is not typically achieved with standard glasses or contact lenses alone. ^{1 3 6 9 10}

Research Team

Magdalena Stec, OD

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Eligibility Criteria

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

I am between 5 and 12 years old.

My child's vision prescription is between +0.50 and -7.50.

Gestational age ≥ 32 weeks

Exclusion Criteria

Current or previous form of myopia control

I do not have conditions like MS, Grave's, myasthenia gravis, diabetes, or Parkinson's affecting my eye movement.

I have been treated for nearsightedness with specific eye drops.

Trial Timeline

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

Treatment Details

Interventions

• Atropine (Anticholinergic Agent)
• MiSight contact lenses (Contact Lens)

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.

Participant Groups

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 Canada for the following indications:

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+

Dr. Michael D. Kelleher

Ann & Robert H Lurie Children's Hospital of Chicago

Chief Medical Officer since 2012

MD from University of Chicago

Dr. Thomas Shanley

Ann & Robert H Lurie Children's Hospital of Chicago

Chief Executive Officer since 2019

MD from University of Chicago Pritzker School of Medicine

Findings from Research

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]

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]

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]

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 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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Treatment of Rapid Progression of Myopia: Case Series and Literature Review. [2021]

2. England 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States 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. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Low concentration atropine and myopia: a narrative review of the evidence for United Kingdom based practitioners. [2023]

6. France pubmed.ncbi.nlm.nih.gov

[Objective refraction in black children: cyclopentolate and tropicamide combination, a reliable alternative to atropine?]. [2022]

7. France pubmed.ncbi.nlm.nih.gov

[Prolonged mydriasis caused by Lamaline]. [2013]

8. Ireland pubmed.ncbi.nlm.nih.gov

Myopia Outcome Study of Atropine in Children (MOSAIC): an investigator-led, double-masked, placebo-controlled, randomised clinical trial protocol. [2021]

9. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Drug kinetics in soft contact lenses. I. In vitro studies]. [2014]

10. Denmark pubmed.ncbi.nlm.nih.gov

Status of cyclopentolate as a cycloplegic in children: a comparison with atropine and homatropine. [2019]