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

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to study changes in eye shape of nearsighted young adults using low-dose atropine eye drops or soft multifocal contact lenses. The main questions it aims to answer are: * do low-dose atropine and soft multifocal contact lenses affect the shape of the peripheral eye? * are changes in peripheral eye shape from these interventions influenced by changes in the focusing system of the eye? Participants will: * have multiple different types of photos taken * have their prescription for glasses/contacts checked * have their eye health checked, including the use of dilating eye drops * be randomly assigned to use eye drops every night or wear special contact lenses daily instead of their typical contacts * will complete five study visits over the course of 12 months Researchers will compare young adults using low-dose atropine to those wearing soft multifocal contact lenses and to those using no intervention to see if using these interventions affects retinal shape.

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 data supports the effectiveness of the treatment Atropine + Contact Lenses for Near-sightedness?

Research shows that using 0.05% atropine eye drops combined with MiSight 1-day contact lenses significantly slowed down the progression of myopia (nearsightedness) in children over one year, reducing the rate of worsening from -1.45 to -0.41 diopters. ^{1 2 3 4 5}

Is the combination of atropine eye drops and MiSight contact lenses safe for humans?

Studies show that using low-concentration atropine eye drops, like 0.05%, with MiSight contact lenses is generally safe for controlling myopia in children, with no adverse reactions reported over a year. ^{1 2 4 6 7}

How does the Atropine + MiSight contact lenses treatment for near-sightedness differ from other treatments?

This treatment combines low-dose atropine eye drops with MiSight contact lenses, which are designed to create a specific focus pattern on the eye to slow myopia progression. This combination has shown effectiveness in reducing the rate of myopia progression more than using either component alone, making it a novel approach compared to traditional single-method treatments like glasses or atropine alone. ^{1 4 5 8 9}

Research Team

Donald O Mutti, OD, PhD

Principal Investigator

Ohio State University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

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]

References

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

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

2. 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]

3. Spain pubmed.ncbi.nlm.nih.gov

Superdiluted atropine at 0.01% reduces progression in children and adolescents. A 5 year study of safety and effectiveness. [2021]

4. England 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. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Low-Concentration Atropine Monotherapy vs. Combined with MiSight 1 Day Contact Lenses for Myopia Management. [2023]

6. England pubmed.ncbi.nlm.nih.gov

A multicenter Spanish study of atropine 0.01% in childhood myopia progression. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Physical, chemical, and microbiological stability study of diluted atropine eye drops. [2022]

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

Effect of Combining 0.01% Atropine with Soft Multifocal Contact Lenses on Myopia Progression in Children. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

Safety of DIMS Spectacle Lenses and Atropine as Combination Therapy for Myopia Progression. [2022]