Atropine + Contact Lenses for Near-sightedness

Overseen By Donald O Mutti, OD, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Ohio State University

Disqualifiers: Eye diseases, Pregnancy, Refractive surgery, 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: 5

Duration: 12 months

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments to determine their effects on eye shape in nearsighted young adults. Participants will either use low-dose atropine eye drops (Atropine Ophthalmic Solution) at night or wear special soft multifocal contact lenses (MiSight 1-day disposable contact lenses) daily for a year. The researchers aim to discover if these treatments alter the eye's shape, particularly the outer edges, and if these changes relate to focusing ability. The trial suits those who are nearsighted, already wear contact lenses, and see well with glasses or contacts. Participants in the observation group will not receive any treatment, serving as a comparison for the study. As a Phase 4 trial, this research helps to understand how these FDA-approved treatments benefit more patients.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you will be randomly assigned to use either eye drops or special contact lenses instead of your typical contacts.

What is the safety track record for these treatments?

Previous studies found low-dose atropine eye drops safe for use up to a year. Some participants experienced mild issues like itchy eyes or blurry vision, but these were uncommon. Research also shows that these drops can slow the progression of nearsightedness in children.

The FDA has approved MiSight 1-day contact lenses to slow nearsightedness in kids. These lenses have been used safely and are well-tolerated, with substantial evidence supporting their safety and effectiveness.

Both treatments generally appear safe, with only minor, temporary discomforts reported. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for near-sightedness because they offer innovative approaches compared to traditional options like corrective glasses or standard contact lenses. Low-dose atropine eye drops are thought to slow the progression of near-sightedness by affecting the eye's growth, a mechanism that's different from merely correcting vision. Meanwhile, MiSight 1-day disposable contact lenses are designed with a special multifocal design that may help manage how light focuses on the retina, potentially reducing the progression of near-sightedness. Both treatments aim not just to correct vision but to tackle the condition's underlying progression, which is a significant advancement over existing solutions.

What evidence suggests that this trial's treatments could be effective for nearsightedness?

Research shows that low-dose atropine eye drops and MiSight 1-day contact lenses can both slow the progression of nearsightedness, or myopia. In this trial, participants will be randomized into different treatment arms to receive either low-dose atropine or MiSight contact lenses. Studies have found that atropine eye drops significantly reduce the rate of myopia progression and slow eye growth in children, with few side effects. Similarly, MiSight contact lenses reduced the worsening of nearsightedness by 59% and slowed eye growth by 52% over several years. Both treatments have a strong record of success, offering promising options for managing nearsightedness. ^{4 6 7 8 9}

Who Is on the Research Team?

Donald O Mutti, OD, PhD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for nearsighted young adults who currently wear contact lenses, have normal binocular vision, and a visual acuity of 20/25 or better. They will be assessed at the first visit to confirm eligibility.

Inclusion Criteria

I am nearsighted.

I currently wear contact lenses.

My vision is normal when using both eyes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to use low-dose atropine eye drops every night or wear soft multifocal contact lenses daily for 12 months

12 months

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Atropine Ophthalmic
• MiSight 1-day disposable contact lenses

Trial Overview

The study compares low-dose atropine eye drops used nightly with soft multifocal contact lenses worn daily against no intervention to see if they change the shape of the peripheral eye and affect focusing over 12 months.

How Is the Trial Designed?

Group I: Soft multifocal contact lenses Experimental Treatment 1 Intervention

Participants randomized to soft multifocal contact lenses will wear MiSight 1-day disposable contact lenses for 5-7 days per week for 12 months.

Group II: Low-dose atropine Experimental Treatment 1 Intervention

Participants randomized to low-dose atropine will instill one drop of 0.05% atropine in each eye at bedtime for 12 months.

Group III: Observation Active Control 1 Intervention

Participants randomized to the observation arm will receive no intervention.

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

Approved in United States as Atropine Ophthalmic for:

• Myopia control in children
• Pupil dilation for diagnostic purposes

Approved in European Union as Atropine Eye Drops for:

• Myopia control in children
• Pupil dilation for diagnostic purposes

Approved in Canada as Atropine Ophthalmic Solution for:

• Myopia control in children
• Pupil dilation for diagnostic purposes

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Published Research Related to This Trial

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]

Atropine 0.01% eye drops significantly reduced myopia progression in children aged 6 to 14, with a mean spherical equivalent change of -0.44 D over 12 months, compared to -1.01 D in the year prior to treatment.

The treatment was found to be safe, with mild and infrequent adverse effects that decreased over time, indicating that atropine 0.01% is a viable option for controlling myopia progression in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multicenter Spanish study of atropine 0.01% in childhood myopia progression. Pérez-Flores, I., Macías-Murelaga, B., Barrio-Barrio, J.[2023]

In a study involving 200 children aged 9-12, daily application of 0.01% superdiluted atropine eyedrops significantly reduced myopia progression by 25%, with the treated group showing a change of -0.14±0.35 diopters compared to -0.65±0.54 diopters in the control group.

The treatment was well tolerated, with only 2% of participants needing to stop due to side effects, indicating a favorable safety profile for the use of atropine eyedrops in managing myopia in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Superdiluted atropine at 0.01% reduces progression in children and adolescents. A 5 year study of safety and effectiveness. Diaz-Llopis, M., Pinazo-Durán, MD.[2021]

The BAM Study found that combining 0.01% atropine with soft multifocal contact lenses (SMCLs) did not provide better control of myopia progression compared to using SMCLs alone, with similar outcomes in myopia progression and axial elongation over three years.

In the study involving 138 children aged around 10 years, both the bifocal-atropine and bifocal groups showed minimal differences in myopia progression, indicating that the addition of atropine does not enhance the effectiveness of SMCLs for myopia management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Combining 0.01% Atropine with Soft Multifocal Contact Lenses on Myopia Progression in Children. Jones, JH., Mutti, DO., Jones-Jordan, LA., et al.[2023]

The study found that in-house prepared low-dose atropine eye-drops (0.01%) using atropine injection are free from bacteria, fungi, or particulate matter, indicating their safety for use.

These eye-drops maintain consistent levels of atropine sulfate over 12 weeks, suggesting they are a viable alternative to commercial products for controlling myopia progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospital-prepared low-dose atropine eye drops for myopia progression control using atropine sulfate injection diluted in normal saline and lubricants. Wongwirawat, N., Kuchonthara, N., Boontanomwong, S., et al.[2022]

DIMS spectacle lenses, when used alone or in combination with 0.01% atropine, do not significantly impair corrected distance visual acuity (CDVA) or contrast sensitivity, making them safe for road traffic participation.

The study found that glare sensitivity was not adversely affected by DIMS lenses or atropine, indicating that these lenses maintain visual safety under conditions that could be challenging for drivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of DIMS Spectacle Lenses and Atropine as Combination Therapy for Myopia Progression. Kaymak, H., Mattern, AI., Graff, B., et al.[2022]

Topical low-dose atropine (0.01%) effectively reduced myopia progression in children, with a significant decrease in myopia compared to a control group using single-vision spectacles, showing a progression of only 0.44 D in the first year versus 1.19 D in the control group.

Combining low-dose atropine with dual-focus contact lenses did not provide additional benefits over atropine alone, and both treatments exhibited a low rebound effect in myopia progression after stopping treatment, indicating sustained efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-Concentration Atropine Monotherapy vs. Combined with MiSight 1 Day Contact Lenses for Myopia Management. Erdinest, N., London, N., Lavy, I., et al.[2023]

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]

Diluted atropine eye drops (0.1, 1.0, 2.5, and 5.0 mg/mL) demonstrated physical, chemical, and microbiological stability for six months, making them a reliable option for long-term treatment of conditions like juvenile myopia.

The study confirmed that atropine concentration, pH, and osmolality remained stable, and sterility was maintained throughout the six-month period, ensuring safety and efficacy for pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical, chemical, and microbiological stability study of diluted atropine eye drops. Saito, J., Imaizumi, H., Yamatani, A.[2022]

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