What side effects are associated with this type of intervention?

The most common treatments for progressive myopia, such as atropine sulfate 0.01%, can have several side effects. These include photophobia (sensitivity to light), blurred near vision, and potential allergic reactions. Higher concentrations of atropine can lead to more pronounced side effects, such as difficulty reading and glare. However, the 0.01% concentration is generally well-tolerated with fewer and less severe side effects.

What other types of research exist?

Promising alternatives to Atropine Sulfate 0.01% for progressive myopia include: 1) Low-dose Atropine (0.025% or 0.05%) which has shown greater efficacy with minimal side effects. 2) Orthokeratology (Ortho-K) lenses that reshape the cornea overnight to slow myopia progression. 3) Multifocal contact lenses designed to reduce eye strain and slow myopia progression. 4) Novel pharmacological agents like 7-methylxanthine, which is under investigation for its potential to slow myopia progression. Patients should discuss these options with their ophthalmologist to determine the best course of action.

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Anticholinergic Agent

Atropine Eye Drops for Near-Sightedness

Q: What prior FDA approvals exist?

The FDA has approved atropine sulfate 0.01% (OT-101) for the treatment of progressive myopia in pediatric subjects. Atropine sulfate is a muscarinic antagonist that works by relaxing the eye muscles and dilating the pupil, which helps to slow the progression of myopia. This treatment is part of a broader category of pharmacologic interventions aimed at managing myopia by affecting the eye's accommodation and growth mechanisms.

Phase 3

Waitlist Available

Research Sponsored by Ocumension (Hong Kong) Limited

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

Have active or a history of chronic or recurrent episodes of ocular inflammation (e.g. moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis, scleritis) in either eye;

Have undergone any form of refractive eye surgery including incisional keratotomy, photorefractive keratectomy [PRK], laser in situ keratomileusis [LASIK], laser-assisted sub- epithelial keratectomy [LASEK]), corneal inlay procedures, conductive keratoplasty, small incision lenticule extraction (SMILE), cataract extraction, or any form of intraocular lens implantation;

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at month 36

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects of OT-101 may include discomfort in the eyes, dryness, redness, blurred vision, and potentially allergic reactions. The exact side effects will be monitored throughout the study.

Eligibility Criteria

Exclusion Criteria

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

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I have or had severe eye inflammation issues.

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I have had surgery to correct my vision.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at month 36

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at month 36

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

Treatment Details

Study Objectives

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

Primary study objectives

Percentage of study eyes with a -0.75D of progressive myopia defined as an increase in spherical equivalent of -0.75D or greater as assessed by cycloplegic autorefraction.

Secondary study objectives

Change in spherical equivalent (D) in the study eye as assessed by cycloplegic autorefraction

Eye

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: OT-101 plus vehicleExperimental Treatment2 Interventions

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

Group II: OT-101 aloneExperimental Treatment1 Intervention

Atropine Sulfate 0.01% Ophthalmic Solution through year 4

Group III: VehiclePlacebo Group1 Intervention

Vehicle (Investigational Product minus active ingredient) through year 4

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vehicle

2013

Completed Phase 3

~5070

0 / 2Eligibility 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

Muscarinic antagonists like Atropine Sulfate 0.01% (OT-101) work by relaxing the eye muscles and dilating the pupil, which helps to slow the progression of myopia. This is crucial for Progressive Myopia patients as it can reduce the risk of severe complications such as retinal detachment, glaucoma, and cataracts. Other treatments, such as orthokeratology and multifocal contact lenses, also aim to alter the focus of light on the retina to slow myopia progression.