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New treatment option for Myopia
Official title Atropine Eyedrops for Myopia Progression in Children and Adolescents (MODERATO STUDY)
ClinicalTrials.gov ID: NCT07028827
What this study is testing
What is 0.05% atropine eye drops?
0.05% atropine eye drops is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for myopia.
Also referred to as atropine sulfate eye drops solutions (0.05%).
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
- Myopia, or shortsightedness, is a multifactorial disorder, governed by environmental and genetic factors. Myopia is the most common ocular disorder worldwide with an increasing prevalence over the past few decades and affecting the quality of life and economic health of individuals worsening socio-economic problems.
- Phase 3: a large, late-stage study
- Time commitment: about 24 months
- 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 3 to 17
You may be able to join if
- Males and females, aged from 3 to less than 18 years.
- people showing myopia with a spherical equivalent refraction of both eyes at least -0.75 D at baseline.
- The intraocular pressure in each eye must be equal or less than 21 mmHg.
- The parents or the legal representative must be informed about the clinical trial and must sign the informed consent form. The exception to consider...
- Women with childbearing potential (WOCBP) (after menarche) who have a negative highly sensitive urine dipstick pregnancy test. Additional pregnancy...
You likely can't join if
- Anisometropia, meaning a significant difference in refractive power between the two eyes exceeding \|1.5\| D.
- Refractive astigmatism exceeding \|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...
- Abnormalities in ocular biometry, except for axial length or previous intraocular or ocular laser/non-laser surgery.
See the full eligibility criteria
- Males and females, aged from 3 to less than 18 years.
- people showing myopia with a spherical equivalent refraction of both eyes at least -0.75 D at baseline.
- The intraocular pressure in each eye must be equal or less than 21 mmHg.
- The parents or the legal representative must be informed about the clinical trial and must sign the informed consent form. The exception to consider is related to the individuals aged above 16 years only in the UK, who...
- Women with childbearing potential (WOCBP) (after menarche) who have a negative highly sensitive urine dipstick pregnancy test. Additional pregnancy testing during the study will be conducted at visits 1, 2, 3, 4, 5, 6.
- WOCBP or males who are using a highly effective birth control method to prevent pregnancies. Eligible highly effective contraceptive methods for WOCBP are combined (which contain estrogen and progestogen) hormonal...
- Anisometropia, meaning a significant difference in refractive power between the two eyes exceeding \|1.5\| D.
- Refractive astigmatism exceeding \|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)
- Abnormalities in ocular biometry, except for axial length or previous intraocular or ocular laser/non-laser surgery.
- History of glaucoma or narrow angles in the anterior chamber of the eye.
- Conditions such as Down syndrome or spastic paralysis.
- Known intolerance or allergies to atropine eye drops or hypersensitivity to any component of the atropine eye drops.
- Pregnancy or breastfeeding.
- History of alcohol or drug abuse.
- Mental or emotional instability that could interfere with study procedures.
- Lack of reliability or cooperation from the patient.
- Any treatment received for myopia within the past three months prior to inclusion in the study.
- Other reasons, at the discretion of the investigator that may deem the subject's participation in the study inappropriate.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Tirana, Albania
- Bari, Italy
- Milan, Italy
- Padua, Italy
- Warsaw, Poland
- Barcelona, Spain
- Cadiz, Spain
- Madrid, Spain
- Belfast, United Kingdom
- Birmingham, United Kingdom
- London, 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 study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tirana, Albania; Bari, Italy; Milan, Italy; Padua, Italy; Warsaw, Poland; Barcelona, Spain and 5 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.