Atropine Eye Drops for Near-Sightedness

Recruiting at 17 trial locations

Overseen By Greg Bennett, M.S. Ed.

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Eyenovia Inc.

Must not be taking: Atropine, Pirenzepine

Disqualifiers: Strabismus, Amblyopia, Diabetes, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 44

Duration: 36 months

438 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests eye drops with small amounts of atropine on people with nearsightedness. It aims to see if the drops can slow down the worsening of their vision by affecting how their eyes grow. Low-dose atropine (0.01%) has been proven to be an effective and safe treatment for slowing the progression of myopia with negligible side effects.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using certain eye treatments like non-study atropine or specific types of contact lenses.

What data supports the effectiveness of the drug Atropine 0.01% Ophthalmic Solution for treating near-sightedness?

Research shows that low-concentration atropine eye drops, including 0.01%, can slow the progression of myopia (near-sightedness) in children and young adults, with studies indicating it is effective in controlling myopic progression with fewer side effects compared to higher concentrations. ^{1 2 3 4 5}

Is atropine eye drop treatment safe for humans?

Studies on low-concentration atropine eye drops (0.01% to 0.1%) for myopia in children have shown that they are generally safe, with fewer visual side effects compared to higher concentrations like 1%. ^{1 2 3 6 7}

How is the drug Atropine 0.01% Ophthalmic Solution unique for treating near-sightedness?

Atropine eye drops, especially at low concentrations like 0.01%, are unique for treating near-sightedness (myopia) because they are emerging as a promising option to slow down the progression of myopia, with fewer side effects compared to higher concentrations. This makes them a novel approach compared to traditional methods, as they are administered directly to the eyes and work by affecting the eye's ability to focus, potentially reducing the rate at which myopia worsens. ^{1 4 6 8 9}

Research Team

Tsontcho Ianchulev, MD, MPH

Principal Investigator

Eyenovia Inc.

Daniel Donatello

Principal Investigator

Bausch & Lomb Incorporated

Eligibility Criteria

This trial is for kids with near-sightedness (myopia) between -1.00 to -6.00 diopters and astigmatism up to 1.50 diopters in both eyes, without significant vision differences between the eyes or other eye conditions. They shouldn't have had any eye surgery, be allergic to atropine, or use certain types of glasses/lenses.

Inclusion Criteria

Refractive correction for each eye must meet the following criteria: myopia within ± 0.50 D of the manifest refraction at the Screening Visit; cylinder power within ± 0.50 D of the manifest refraction at the Screening Visit; when cylinder power is < 1.00 D, axis within ± 15 degrees of the manifest refraction; when cylinder power is ≥ 1.00 D, axis within ± 5 degrees of the manifest refraction.

I have a refractive error of between -1.00 and -6.00 in both eyes, with astigmatism of ≤ 1.50 in both eyes and anisometropia of < 1.50.

The person has a best-corrected visual acuity of 0.2 logMAR or better in their current correction and an interocular difference of ≤ 0.1 logMAR.

Exclusion Criteria

I have had surgery on my eyelid, for eye alignment, inside my eye, or to correct my vision.

I have a condition like diabetes that could affect my eyesight.

I do not have any severe eye problems or unstable health conditions that could interfere with the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Run-in

Participants complete a run-in period using the microdose dispenser to administer study drug 'vehicle' solution daily in both eyes

2-4 weeks

Treatment

Participants receive microdosed atropine 0.01%, atropine 0.1%, or placebo ophthalmic solution daily in both eyes

36 months

Visits at 1, 6, 12, 18, 24, 30, and 36 months

Re-randomization and Extended Treatment

Participants are re-randomized and continue treatment with either placebo or atropine ophthalmic solution

12 months

Visits at 42 and 48 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Atropine 0.01% Ophthalmic Solution
• Atropine 0.1% Ophthalmic Solution
• Placebo Ophthalmic Solution

Trial Overview The study tests if microdosed Atropine solutions (0.01% and 0.1%) can slow down myopia progression in children compared to a placebo solution over four years with regular check-ups every six months after the first year.

Participant Groups

Group I: Atropine 0.1% Ophthalmic Solution Experimental Treatment 1 Intervention

Atropine 0.1% ophthalmic solution administered daily in both eyes using a microdose dispenser

Group II: Atropine 0.01% Ophthalmic Solution Experimental Treatment 1 Intervention

Atropine 0.01% ophthalmic solution administered daily in both eyes using a microdose dispenser

Group III: Placebo Ophthalmic Solution Placebo Group 1 Intervention

Placebo ophthalmic solution administered daily in both eyes using a microdose dispenser

Who Is Running the Clinical Trial?

Eyenovia Inc.

Lead Sponsor

Trials

9

Recruited

950+

Bausch & Lomb Incorporated

Lead Sponsor

Trials

263

Recruited

59,400+

Dr. Christina Ackermann

Bausch & Lomb Incorporated

Chief Medical Officer since 2023

MD from Harvard Medical School

Brent Saunders

Bausch & Lomb Incorporated

Chief Executive Officer since 2023

BA from the University of Pittsburgh, JD and MBA from Temple University

Findings from Research

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]

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]

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]

References

1. 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]

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

Atropine and bifocals can slow the progression of myopia in children. [2013]

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

Atropine for the treatment of childhood myopia: safety and efficacy of 0.5%, 0.1%, and 0.01% doses (Atropine for the Treatment of Myopia 2). [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Short-term effects of low-concentration atropine eye drops on pupil size and accommodation in young adult subjects. [2018]

5. India pubmed.ncbi.nlm.nih.gov

Effect of atropine 0.01% on progression of myopia. [2022]

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

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

7. Denmark pubmed.ncbi.nlm.nih.gov

Systemic bioavailability of ocularly applied 1% atropine eyedrops. [2022]

8. 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]

9. China pubmed.ncbi.nlm.nih.gov

Low-Concentration Atropine Eye Drops for Myopia Progression. [2020]