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New treatment option for Myopia Progression
Official title Atropine in the Treatment of Myopia Study in Malaysia
ClinicalTrials.gov ID: NCT07329777
What this study is testing
What is Low dose atropine sulfate eye drops?
Low dose atropine sulfate eye drops is an investigational medicine, being studied as a potential treatment for myopia progression.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This clinical trial is designed to assess the efficacy and safety of Atropine Sulphate 0.025% w/v Eye Drops compared to placebo in a randomized, double-blind, placebo-controlled study for the management of myopia progression in children.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 10
You may be able to join if
- Male or female children between 5 to 10 years of age.
- Children with refractive error of spherical equivalent -1.00 D up to -6.00 D in each eye.
- Children with active myopia progression of at least spherical equivalent -0.50 D within the last 12 months.
- Children with astigmatism of less than -1.50 D
- Children having distance vision correctable to logMAR 0.2 or better in both eyes.
You likely can't join if
- History of hypersensitivity or allergy to study drug and/or any of the study medication ingredients.
- Children with prior and/or concomitant use of other myopia control drugs, contact lens or spectacles (except normal spectacles including...
- Children with congenital myopia.
- Children using Ortho K and Myopia Lens.
- Children with ocular or systemic diseases which may affect vision or refractive error.
- Children with any ocular condition wherein topical atropine is contraindicated.
See the full eligibility criteria
- Male or female children between 5 to 10 years of age.
- Children with refractive error of spherical equivalent -1.00 D up to -6.00 D in each eye.
- Children with active myopia progression of at least spherical equivalent -0.50 D within the last 12 months.
- Children with astigmatism of less than -1.50 D
- Children having distance vision correctable to logMAR 0.2 or better in both eyes.
- A difference between non-cycloplegic subjective spherical refraction and cycloplegic subjective spherical refraction of not greater than -1.00 D.
- Children with normal intraocular pressure of not greater than 21 mmHg in either eye.
- Children with normal ocular health other than myopia.
- Children must be in good general health with no history of cardiac or respiratory diseases as per investigator's discretion and does not affect the study treatment or subsequent follow-ups.
- No asthma-requiring medications in the past one year.
- No known allergy to atropine, cyclopentolate, proparacaine and benzalkonium chloride.
- Willing and able to comply with scheduled visits and other study procedures.
- Written Informed Consent from parent and assent from child has been obtained.
- History of hypersensitivity or allergy to study drug and/or any of the study medication ingredients.
- Children with prior and/or concomitant use of other myopia control drugs, contact lens or spectacles (except normal spectacles including tinted/anti-glare glasses) etc.
- Children with congenital myopia.
- Children using Ortho K and Myopia Lens.
- Children with ocular or systemic diseases which may affect vision or refractive error.
- Children with any ocular condition wherein topical atropine is contraindicated.
- Children with defective binocular function or stereopsis.
- Children with amblyopia (lazy eyes) or manifest strabismus including intermittent tropia.
- Previous or current use of atropine or pirenzepine.
- Children with any other conditions precluding adherence to the protocol including unwillingness to refrain from the use of other myopia control drug, contact lens or spectacles (except normal) spectacles including...
- Children with any other condition which may put the subject to risk during study or affect study results based on investigator's judgement.
- Children participated in any clinical study within 30 days prior to randomization.
The study team makes the final eligibility decision.
Where it's taking place
- Kuala Lumpur, Cheras, Malaysia
- Kuala Lumpur, Petaling Jaya, Malaysia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 10 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kuala Lumpur, Cheras, Malaysia; Kuala Lumpur, Petaling Jaya, Malaysia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.