BridgeMD
A phase III, randomized, double blind, multiple doses, placebo-controlled parallel-group, adaptive study to evaluate the efficacy of atropine to treat the progression of myopia in children and adolescents from 3 to less than 18 years of age (MODERATO Study)
EU CTIS ID: 2023-510439-13-00
What this study is testing
To evaluate the efficacy of atropine eyedrops at two concentrations, 0.025% and 0.05%, over a 24-month treatment period, in slowing the progression of myopia in children and adolescents from 3 to 18 years old.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male and female subjects from 3 to less than 18 years of age.
- Subjects showing myopia with a SER of both eyes at least -0.75 D at baseline.
- Intraocular pressure ≤ 21 mm Hg in each eye.
- Parents or legal representative who have been informed about the clinical trial and have signed the informed consent form, with the exception of subjects aged over 16 years only in the UK, who can provide their own consent, according to the local regulations.
- Women with childbearing potential (WOCBP) who have a negative highly sensitive urine dipstick pregnancy test. Additional pregnancy testing during the clinical trials will be conducted at visits 1, 2, 3, 4, 5, 6.
- WOCBP or males who are using a highly effective birth control method for contraception. Eligible highly effective contraceptive methods for WOCBP are combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device; intrauterine hormone-releasing system. Sexual abstinence represents a highly effective contraceptive method, if in line with the subject's normal habits.
You likely can't join if
- Anisometropia, meaning a significant difference in refractive power between the two eyes exceeding |1.5| D.
- Pregnancy or breastfeeding.
- Previous or current alcohol or drug abuse.
- Mental or emotional instability that might jeopardize the compliance with the trial procedures.
- Unreliability or lack of cooperation.
- History of any myopia control treatment within 3 months before inclusion: e.g. peripheral-plus or diffusion-optics-technology glasses, orthokeratology contact lenses, peripheral-plus/multifocal contact lenses, atropine eyedrops.
See the full eligibility criteria
Who can join
- Male and female subjects from 3 to less than 18 years of age.
- Subjects showing myopia with a SER of both eyes at least -0.75 D at baseline.
- Intraocular pressure ≤ 21 mm Hg in each eye.
- Parents or legal representative who have been informed about the clinical trial and have signed the informed consent form, with the exception of subjects aged over 16 years only in the UK, who can provide their own consent, according to the local regulations.
- Women with childbearing potential (WOCBP) who have a negative highly sensitive urine dipstick pregnancy test. Additional pregnancy testing during the clinical trials will be conducted at visits 1, 2, 3, 4, 5, 6.
- WOCBP or males who are using a highly effective birth control method for contraception. Eligible highly effective contraceptive methods for WOCBP are combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device; intrauterine hormone-releasing system. Sexual abstinence represents a highly effective contraceptive method, if in line with the subject's normal habits.
What rules you out
- Anisometropia, meaning a significant difference in refractive power between the two eyes exceeding |1.5| D.
- Pregnancy or breastfeeding.
- Previous or current alcohol or drug abuse.
- Mental or emotional instability that might jeopardize the compliance with the trial procedures.
- Unreliability or lack of cooperation.
- History of any myopia control treatment within 3 months before inclusion: e.g. peripheral-plus or diffusion-optics-technology glasses, orthokeratology contact lenses, peripheral-plus/multifocal contact lenses, atropine eyedrops.
- Other reasons why, in the opinion of the investigator, the subjects should not participate in the trial.
- Patients who have consented to participate in the clinical trial, but do not meet one or more eligibility criteria required for participation in the trial during the screening procedures, and subsequently are not randomly assigned to the study treatment or entered in the study, are considered screening failures.
- Refractive astigmatism (ΔTK) > |1.5| D.
- Presence of ocular pathologies such as pathological myopia, corneal scars, or other anterior or posterior eye pathologies.
- History of amblyopia or strabismus.
- Presence of a history of a retinal dystrophy or systemic disorder that may predispose to severe myopia (e.g., Marfan syndrome, retinitis pigmentosa, Stickler syndrome, retinopathy of prematurity)
- Abnormal ocular biometry aside from axial length (e.g., keratoconus, lenticonus, spherophakia) or previous intraocular or ocular laser/non-laser surgery.
- History of glaucoma; anatomic narrow anterior chamber angles.
- Down syndrome or spastic paralysis.
- Known intolerances/allergies against atropine eyedrops, or hypersensitivity to any component of the IMP.
The study team makes the final eligibility decision.
Where it's taking place
- Albania
- United Kingdom
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, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Albania; United Kingdom. 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 EU CTIS; the study team decides eligibility.