What side effects are associated with this type of intervention?

Atropine ophthalmic solutions, used to slow the progression of myopia, can have several side effects. Commonly reported side effects include photophobia (sensitivity to light), blurred vision, and difficulty focusing on near objects due to the dilation of the pupils. In some cases, patients may experience eye irritation or allergic reactions. Higher concentrations of atropine are associated with more pronounced side effects, whereas lower concentrations, such as 0.01%, tend to have fewer and milder side effects.

What prior FDA approvals exist?

Currently, there are no specific FDA-approved treatments for the progression of near-sightedness (myopia) that are similar to atropine ophthalmic solutions. Atropine, which inhibits muscarinic receptors, is being studied for its potential to slow myopia progression, but it has not yet received FDA approval for this indication. Other treatments for myopia primarily focus on corrective measures such as glasses, contact lenses, and refractive surgery rather than pharmacological interventions.

What other types of research exist?

Promising alternatives to Atropine Ophthalmic Solution for myopia treatment include low-dose atropine (0.01% or 0.1%), which has shown efficacy in slowing myopia progression with fewer side effects. Additionally, orthokeratology (overnight contact lenses that reshape the cornea) and multifocal contact lenses are non-pharmacological options that have demonstrated effectiveness in managing myopia. Emerging treatments such as low-level red-light therapy and novel pharmacological agents like pirenzepine are also being explored for their potential benefits in myopia control.

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Anticholinergic Agent

Atropine Eye Drops for Near-Sightedness

Phase 3

Recruiting

Research Sponsored by Eyenovia Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Must not have

Prior eyelid, strabismus, intraocular, or refractive surgery.

History of premature birth by parent's report.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include light sensitivity due to pupil dilation, difficulty focusing on close objects, dry eyes or mouth, headache, and an allergic reaction if sensitive to atropine.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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My child was born prematurely.

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I have a history of eye conditions or surgery that affects my vision.

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I have used atropine or similar eye drops for myopia.

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I have an eye condition affecting parts like the cornea or retina.

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I have had a procedure to block my tear ducts.

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I cannot undergo certain tests due to existing neurological or genetic conditions.

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I have or had crossed eyes, lazy eye, or involuntary eye movement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Myopia progression

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Atropine 0.1% Ophthalmic SolutionExperimental Treatment1 Intervention

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

Group II: Atropine 0.01% Ophthalmic SolutionExperimental Treatment1 Intervention

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

Group III: Placebo Ophthalmic SolutionPlacebo Group1 Intervention

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

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Atropine ophthalmic solutions, used to treat near-sightedness (myopia), work by inhibiting muscarinic receptors in the eye, which helps to slow the progression of myopia. This is crucial for patients as it can reduce the risk of severe complications associated with high myopia, such as retinal detachment, macular degeneration, and glaucoma. Other common treatments include corrective lenses and refractive surgery, which correct the refractive error but do not prevent the progression of myopia.