Atropine Eye Drops for Near-Sightedness

Recruiting at 16 trial locations

Overseen By Prateek Gajwani

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

678 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing special eye drops with a tiny amount of atropine to see if they can slow down worsening nearsightedness in children. The drops work by relaxing eye muscles and slowing down changes in the eye. Lower doses of atropine have shown effectiveness with fewer side effects.

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.

What evidence supports the effectiveness of the drug OT-101 Ophthalmic Solution for treating near-sightedness?

Research shows that low-concentration atropine eye drops can help slow down the progression of myopia (near-sightedness) in children, with studies indicating that concentrations as low as 0.01% can be effective. ^{1 2 3 4 5}

Is it safe to use atropine eye drops for near-sightedness?

Research shows that low-dose atropine eye drops, such as 0.01% and 0.1%, have been studied for safety in controlling myopia (near-sightedness) in children and young adults. Some studies report potential side effects like allergic reactions and other eye symptoms, but overall, these low concentrations are generally considered safe for use. ^{1 6 7 8 9}

How is OT-101 Ophthalmic Solution different from other drugs for near-sightedness?

OT-101 Ophthalmic Solution, which contains atropine, is unique because it uses low concentrations of atropine eye drops to slow down the progression of near-sightedness (myopia) in children and adolescents. This approach is different from other treatments as it focuses on using very low doses, such as 0.01%, to minimize side effects while still being effective. ^{1 2 10 11 12}

Research Team

Keith Lane

Principal Investigator

ORA, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

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]

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]

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]

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. China pubmed.ncbi.nlm.nih.gov

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

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

The long-term results of using low-concentration atropine eye drops for controlling myopia progression in schoolchildren. [2013]

4. India pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

Bifocal use in hyperopic anisometropic amblyopia treated with atropine: a proof-of-concept randomized trial. [2023]

6. India pubmed.ncbi.nlm.nih.gov

Allergic reactions to atropine eye drops for retardation of progressive myopia in children. [2022]

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

Symptoms and ocular findings associated with administration of 0.01% atropine in young adults. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Five-year results of atropine 0.01% efficacy in the myopia control in a European population. [2023]

9. England 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. [2023]

10. 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]

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

Two-Year Clinical Trial of the Low-Concentration Atropine for Myopia Progression (LAMP) Study: Phase 2 Report. [2020]

12. 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]