Atropine Eye Drops for Near-Sightedness

Not currently recruiting at 16 trial locations

Overseen By Stephen Glaser, MD

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Ocumension (Hong Kong) Limited

Disqualifiers: Ocular inflammation, Myopia control treatment, Refractive surgery, 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: 12

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests OT-101 Ophthalmic Solution eye drops to determine if they can slow the progression of near-sightedness (myopia) in children. Researchers aim to assess the safety and effectiveness of these drops compared to a placebo (a substance with no active medicine). The trial includes different groups: one using the active eye drops for four years, another switching to a placebo after three years, and a third using only the placebo. Children whose myopia has worsened by at least -0.50 in the past year and who have no history of eye inflammation or recent myopia treatments might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that certain eye treatments and surgeries are not allowed if done recently.

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

Research has shown that low-dose atropine eye drops, such as the 0.01% concentration, have been tested for safety in children with myopia (nearsightedness). Studies suggest these drops are generally safe and well-tolerated. Specifically, atropine concentrations between 0.01% and 0.05% showed very few side effects in children aged 4 to 12 years over three years. Most side effects, if they occur, are mild and may include temporary eye irritation or blurred vision. Overall, the safety of low-dose atropine in children appears promising, with only minor and manageable side effects reported. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for myopia?

Researchers are excited about OT-101 because, unlike other treatments for near-sightedness, it utilizes atropine sulfate, which is known for its potential to slow the progression of myopia in children. Most existing treatments focus on correcting vision with glasses or contact lenses, but OT-101 targets the underlying progression of the condition itself. Additionally, OT-101 is conveniently delivered as an eye drop, making it a simple and non-invasive option for patients. This approach could offer a significant advantage over standard methods, providing long-term benefits by addressing the root cause of near-sightedness.

What evidence suggests that OT-101 Ophthalmic Solution might be an effective treatment for myopia?

Research has shown that atropine eye drops, such as the 0.01% concentration in OT-101, can slow the worsening of nearsightedness (myopia) in children. In a study with 438 children aged 4 to 12, low-dose atropine drops, including the 0.01% dose, significantly reduced myopia progression compared to a placebo (a substance with no active ingredient). In this trial, some participants will receive OT-101 alone, while others will receive OT-101 plus a vehicle or the vehicle alone. Another analysis found that 0.01% atropine drops were more effective than a placebo in slowing myopia. These findings suggest that OT-101 could be a promising option for managing myopia in children. ^{4 6 7 8 9}

Who Is on the Research Team?

Keith Lane

Principal Investigator

ORA, Inc.

Are You a Good Fit for This Trial?

This trial is for children with near-sightedness who have seen their condition worsen by at least -0.50D in the past year, and have less than or equal to 1.50DC of astigmatism. Kids can't join if they've had treatments for myopia control in the last 6 months or any eye surgery, or if they suffer from chronic eye inflammation.

Inclusion Criteria

Have refractive error by cycloplegic autorefraction at baseline (Visit 1) in the study eye of: myopia greater or equal to -1.00D of spherical equivalent astigmatism less than or equal to 1.50DC progression of at least -0.50D of spherical equivalent in the last 12 months;

The person has had a progression of at least -0.50D of spherical equivalent in the last 12 months.

The person has astigmatism that is less than or equal to 1.50 degrees.

Exclusion Criteria

I have or had severe eye inflammation issues.

I haven't used any special treatments to control nearsightedness in the last 6 months, except for regular glasses or soft contacts.

I have had surgery to correct my vision.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Stage 1 Treatment

Participants receive OT-101 or placebo once daily for 3 years

3 years

9 visits (in-person)

Stage 2 Treatment

Participants are re-randomized to continue OT-101 or switch to placebo for 1 year

1 year

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• OT-101 Ophthalmic Solution
• Vehicle

Trial Overview

The study tests OT-101 Ophthalmic Solution against a placebo (vehicle) to see if it's safe and effective for treating myopia in kids. It's a phase III trial where participants are randomly assigned to either the treatment or placebo group without knowing which one they're getting.

How Is the Trial Designed?

Group I: OT-101 plus vehicle Experimental Treatment 2 Interventions

Atropine Sulfate 0.01% Ophthalmic Solution through year 3 followed by vehicle for 1 year

Group II: OT-101 alone Experimental Treatment 1 Intervention

Atropine Sulfate 0.01% Ophthalmic Solution through year 4

Group III: Vehicle Placebo Group 1 Intervention

Vehicle (Investigational Product minus active ingredient) through year 4

Who Is Running the Clinical Trial?

Ocumension (Hong Kong) Limited

Lead Sponsor

Trials

1

Recruited

680+

Statistics & Data Corporation

Industry Sponsor

Trials

5

Recruited

1,100+

Statistics & Data Corporation

Collaborator

Trials

4

Recruited

1,000+

ORA, Inc.

Industry Sponsor

Trials

72

Recruited

9,200+

Stuart Abelson

ORA, Inc.

Chief Executive Officer since 2007

BSc in Neuroscience from Bates College, MBA from Northwestern University

Dr. Gustavo De Moraes

ORA, Inc.

Chief Medical Officer since 2022

MD, PhD in Ophthalmic Sciences, MPH in Biostatistics

Published Research Related to This Trial

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]

In a study involving 97 Danish children aged 6 to 12, low-dose atropine eye drops (0.1% and 0.01%) were found to be safe over a 12-month period, with most reported adverse events being mild.

The treatment showed a modest reduction in myopia progression, with the 0.1% group experiencing 0.24 D less progression in spherical equivalent refraction compared to placebo, although this result was not statistically significant after adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of 0.01% and 0.1% low-dose atropine eye drop regimens for reduction of myopia progression in Danish children: a randomized clinical trial examining one-year effect and safety. Hansen, NC., Hvid-Hansen, A., Møller, F., 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]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04770610

NCT04770610 | Study of OT-101 in Treating Myopia

This is a phase III, randomized, double-masked, placebo-controlled, parallel-group, multi-center study to evaluate the safety tolerability and efficacy of OT- ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11683068/

Effectiveness of various atropine concentrations in myopia ...

Forest plots indicated that five concentrations (0.01%, 0.02%, 0.025%, 0.05%, and 1%) were more effective than a placebo in controlling myopia ...

3.

ophthalmologyadvisor.com

ophthalmologyadvisor.com/news/atropine-eye-drops-under-review-pediatric-myopia/

Low-Dose Atropine Eye Drops Under Review for Pediatric ...

The FDA has accepted for review the New Drug Application for SYD-101 (atropine sulfate) to slow the progression of myopia in children.

4.

withpower.com

withpower.com/trial/phase-3-myopia-degenerative-3-2021-325c2

Atropine Eye Drops for Near-Sightedness

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 ...

5.

frontiersin.org

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

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 ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04770610

NCT04770610 | Study of OT-101 in Treating Myopia

This is a phase III, randomized, double-masked, placebo-controlled, parallel-group, multi-center study to evaluate the safety tolerability and efficacy of OT- ...

7.

ophthalmologyscience.org

ophthalmologyscience.org/article/S2666-9145(25)00258-1/fulltext

Efficacy and Safety of Low-Concentration Atropine in ...

To evaluate the efficacy and safety of low-concentration atropine ophthalmic solution for slowing disease progression in children with myopia ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7465901/

Stability of Ophthalmic Atropine Solutions for Child Myopia ...

Low-dose atropine eyedrops have been shown to limit myopia evolution during treatment. However, there are currently no commercial industrial forms available and ...

9.

mykidsvision.org

mykidsvision.org/knowledge-centre/atropine-eye-drops-for-myopia-control-in-children

Atropine eye drops for myopia control in children

Atropine 0.01% to 0.05% has been shown to have minimal side effects in children who were 4 to 12 years of age at the start of treatment.6 This three year study ...