BridgeMD
New treatment option for Progressive Myopia
Official title MAD Trial: Myopia Atropine Dose
ClinicalTrials.gov ID: NCT05667454
What this study is testing
What is Atropine Ophthalmic 0.05%?
Atropine Ophthalmic 0.05% is an investigational medicine, being studied as a potential treatment for progressive myopia.
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
- The goal of this interventional study is to compare the efficacy of Atropine 0.05% to Atropine 0.5% treatment against progression of axial length in European children with progressive myopia, and to evaluate the safety, adherence, and reasons for nonresponse. Subjects will use Atropine eye drops for a period of 3 years, followed by a 2 year observational period.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 11
You may be able to join if
- Children aged 6 to ≤ 11 years with bilateral myopia
- Onset of myopia ≥ 4 years of age
- History of progression
- SER of at least -1.00D and no greater than -6.00D in each eye measured using cycloplegic auto refraction
- Intraocular pressure \< 21 mm Hg in each eye
You likely can't join if
- Allergy to atropine or other excipients of the eye drops
- History of amblyopia or strabismus
- History of retinal dystrophy or systemic disorder
- Abnormal ocular biometry aside from axial length
- History of glaucoma
- Chronic use of topical or systemic antimuscarinic/anticholinergic medications in the 21 days prior to screening, and/or anticipated need for chronic...
See the full eligibility criteria
- Children aged 6 to ≤ 11 years with bilateral myopia
- Onset of myopia ≥ 4 years of age
- History of progression
- SER of at least -1.00D and no greater than -6.00D in each eye measured using cycloplegic auto refraction
- Intraocular pressure \< 21 mm Hg in each eye
- Distance vision correctable to at least 0.1 Log MAR (logarithm of the minimum angle of resolution) in each eye
- Allergy to atropine or other excipients of the eye drops
- History of amblyopia or strabismus
- History of retinal dystrophy or systemic disorder
- Abnormal ocular biometry aside from axial length
- History of glaucoma
- Chronic use of topical or systemic antimuscarinic/anticholinergic medications in the 21 days prior to screening, and/or anticipated need for chronic use over the duration of the study (i.e., more than 7 consecutive days...
- Chronic use (more than 3 days a week) of topical ophthalmological medication (prescribed or over the counter) other than the assigned study medication. The use of artificial tears is allowed but not in the 1 hour before...
- The anticipated need to use chronic ophthalmic or systemic oral corticosteroids during the study. (i.e., \< 2 weeks)
- Prior myopia treatments.
- Employees of the study center and their family members.
The study team makes the final eligibility decision.
Where it's taking place
- Almere Stad, Netherlands
- Amsterdam, Netherlands
- Delft, Netherlands
- Deventer, Netherlands
- Dordrecht, Netherlands
- Ede, Netherlands
- Goes, Netherlands
- Heerenveen, Netherlands
- Heerhugowaard, Netherlands
- Leiden, Netherlands
- Lelystad, Netherlands
- Maastricht, Netherlands
- Nieuwegein, Netherlands
- Nijmegen, Netherlands
- Rotterdam, Netherlands
- The Hague, Netherlands
- Tiel, Netherlands
- Tilburg, Netherlands
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, 6 years to 11 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Almere Stad, Netherlands; Amsterdam, Netherlands; Delft, Netherlands; Deventer, Netherlands; Dordrecht, Netherlands; Ede, Netherlands and 12 more location(s). 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.