Atropine Eye Drops for Near-Sightedness

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different doses of atropine eye drops might slow the progression of myopia (near-sightedness). Participants will use either a low dose, higher dose, or placebo (inactive drops) daily in both eyes for 48 months. The goal is to determine which treatment most effectively and safely reduces the worsening of myopia over time. Suitable candidates include those with mild to moderate myopia who have not previously used certain eye treatments. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment for myopia.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that 0.01% and 0.1% atropine eye drops are safe for children to use over twelve months, with no serious side effects reported. Research indicates that these low-dose atropine eye drops effectively slow the progression of myopia, or nearsightedness.

Atropine 0.01% eye drops have been tested for safety and have shown no major issues for children. They do not affect conditions like exotropia (a type of eye alignment issue) or binocular vision (the ability to use both eyes together).

For the 0.1% atropine drops, studies have demonstrated safety over three years, with no significant problems reported in children using them. The primary goal of these drops is to slow the progression of myopia.

Both concentrations, 0.01% and 0.1%, are well-tolerated, meaning most children do not have trouble using them. This trial will confirm these findings over a longer period and provide more information on the effectiveness of these drops. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about atropine eye drops for near-sightedness because they offer a promising new approach to slowing the progression of this condition. Unlike traditional corrective lenses or surgeries, atropine drops are a non-invasive treatment that can be easily administered at home. The study is testing two concentrations: 0.01% and 0.1%, both of which work by relaxing the eye muscles and potentially reducing the elongation of the eyeball, which is a common cause of near-sightedness. This method could be a game-changer for young people whose vision is rapidly changing, providing an alternative to more conventional solutions.

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

Research shows that atropine eye drops can slow the progression of nearsightedness (myopia). In this trial, participants will receive either the 0.01% atropine solution, the 0.1% atropine solution, or a placebo. Studies have found that the 0.01% atropine solution is significantly more effective than a placebo in reducing myopia progression over several years, with fewer visual side effects compared to higher doses. Data from a five-year clinical trial supports its use as a safe and effective method for managing myopia in children. For the 0.1% atropine solution, research suggests it outperforms the 0.01% solution, with benefits observed over three years. Both concentrations show promise in controlling myopia, with the 0.1% solution potentially having a stronger effect. ^{3 5 6 7 8}

Who Is on the Research Team?

Tsontcho Ianchulev, MD, MPH

Principal Investigator

Eyenovia Inc.

Daniel Donatello

Principal Investigator

Bausch & Lomb Incorporated

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12137072/

A systematic review with meta-analysis on the efficacy of ...

Similar to SER, 0.01% atropine eyedrops are significantly more effective than placebo in reducing myopia progression, with an average reduction ...

2.

jamanetwork.com

jamanetwork.com/journals/jamaophthalmology/fullarticle/2820256

0.01% Atropine Eye Drops in Children With Myopia and ...

0.01% atropine eye drops are effective and safe in slowing myopia progression without interfering with exotropia conditions or binocular vision in children ...

3.

bjo.bmj.com

bjo.bmj.com/content/109/9/1056

3-year results of 0.01% and 0.1% loading dose atropine ...

This paper reports the safety and efficacy of low-dose atropine eye drops (0.01% and 0.1% loading dose) after 2 years of intervention followed by a 1-year ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2162098924001427

Low-concentration atropine for controlling myopia onset ...

Thus, the data revealed that 0.05 % atropine consistently outperformed 0.025 % and 0.01 % concentrations, with efficacy remaining stable over the two-year ...

5.

aaojournal.org

aaojournal.org/article/S0161-6420%252815%252900675-2/fulltext

Five-Year Clinical Trial on Atropine for the Treatment of ...

Over 5 years, atropine 0.01% eyedrops were more effective in slowing myopia progression with less visual side effects compared with higher doses of atropine.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37904082/

Safety and efficacy of 0.01% and 0.1% low-dose atropine ...

Low-dose atropine eye drops are safe over twelve months in otherwise healthy children. There may be a modest but clinically relevant reduction in myopia ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10236322/

Efficacy and Safety of 0.01% and 0.02% Atropine for the ...

Trial results show that the efficacy and safety observed may be supportive of low dose atropine as a pharmacological treatment option for myopia ...

8.

frontiersin.org

frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2025.1497667/full

A systematic review with meta-analysis on the efficacy of ...

This meta-analysis was aimed at summarizing the evidence on the efficacy of 0.01% Atropine eyedrops on the reduction of myopia progression.