75 Participants Needed

Atropine + Contact Lenses for Near-sightedness

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MG
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Overseen ByDonald O Mutti, OD, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Phase 4
Sponsor: Ohio State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

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.12467

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.14589

Research Team

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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.
See 1 more

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
3Treatment groups
Experimental Treatment
Active Control
Group I: Soft multifocal contact lensesExperimental Treatment1 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 atropineExperimental Treatment1 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: ObservationActive Control1 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
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Approved in Canada as Atropine Ophthalmic Solution for:
  • Myopia control in children
  • Pupil dilation for diagnostic purposes

Find a Clinic Near You

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.
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.
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.
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]

References

Treatment of Rapid Progression of Myopia: Case Series and Literature Review. [2021]
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]
Superdiluted atropine at 0.01% reduces progression in children and adolescents. A 5 year study of safety and effectiveness. [2021]
Hospital-prepared low-dose atropine eye drops for myopia progression control using atropine sulfate injection diluted in normal saline and lubricants. [2022]
Low-Concentration Atropine Monotherapy vs. Combined with MiSight 1 Day Contact Lenses for Myopia Management. [2023]
A multicenter Spanish study of atropine 0.01% in childhood myopia progression. [2023]
Physical, chemical, and microbiological stability study of diluted atropine eye drops. [2022]
Effect of Combining 0.01% Atropine with Soft Multifocal Contact Lenses on Myopia Progression in Children. [2023]
Safety of DIMS Spectacle Lenses and Atropine as Combination Therapy for Myopia Progression. [2022]
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