BridgeMD
A Randomised, double-blinded, placebo-controlled, multicenter study of efficacy, safety and side effects of highly diluted atropine collyrium in slowing the progression of myopia (shortsightedness) in children
EU CTIS ID: 2024-515888-54-00
What this study is testing
The primary objective of the clinical trial is to determine the difference in axial eye length (AXL) over a 12M application period with 0,02% atropine versus placebo.
- 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
- Age 6-12 years
- Diagnosis of myopia - spherical component of refraction -0.5 Dsf to - 4.75 Dsf and astigmatism 0 to -2.5 Dcyl at least on one of the eyes
- BCDVA of worse eye better or equal to 0.2 logMAR (according to ETDRS test, 85 cd / m2)
- Corneal topography index (anterior corneal area): KI < 1,07, ISV < 37 at least on one of the eyes
- Normal ocular finding and history in both eyes (except for spectacle correction and banal eye diseases, eg history of acute conjunctivitis, lacrimal lavage in early childhood)
- Normal binocular functions in both eyes (in sensory and motor components) with the exception of exophoria equal to or more than 8 Dp incl. in an alternating covering test with prisms
You likely can't join if
- Previous pharmacological, surgical and / or orthokeratological therapy of myopia
- Presence of rhinitis sicca
- Previous long-term treatment with atropine
- Presence and / or history of allergic reaction to ophthalmologics (atropine; cycloplegics - cyclopentolate, tropicamide; local anesthetics - eg oxybuprocaine, etc.)
- Presence of strabism, amblyopia, glaucoma, corneal damage and / or corneal scarring and current and / or previous ocular conservative, contactology and / or surgical therapy
- Presence and / or history of general disease (incl. allergy, myasthenia gravis, cardiac, respiratory and / or renal-urological disease and / or dysfunction)
See the full eligibility criteria
- Age 6-12 years
- Diagnosis of myopia - spherical component of refraction -0.5 Dsf to - 4.75 Dsf and astigmatism 0 to -2.5 Dcyl at least on one of the eyes
- BCDVA of worse eye better or equal to 0.2 logMAR (according to ETDRS test, 85 cd / m2)
- Corneal topography index (anterior corneal area): KI < 1,07, ISV < 37 at least on one of the eyes
- Normal ocular finding and history in both eyes (except for spectacle correction and banal eye diseases, eg history of acute conjunctivitis, lacrimal lavage in early childhood)
- Normal binocular functions in both eyes (in sensory and motor components) with the exception of exophoria equal to or more than 8 Dp incl. in an alternating covering test with prisms
- Normal intraocular pressure (≤ 22 torr, contactless applanation) in both eyes
- Fulfillment of the indication criterion of AXL growth in 6-8M in 9M observation period before enrollment to the study according to the data in the patient medical documentation in at least on one of the eyes: Age AXL growth in 6M AXL growth in 7M AXL growth in 8M 6-7 years, 0.10 mm 0.11 mm 0.12 mm 8-9 years, 0.11 mm 0.12 mm 0.13 mm 10-11 years, 0.12 mm 0.13 mm 0.14 mm
- The willingness of the patient and his / her parents / legal guardian to undergo a two-year period of daily application of eye drops, a threeyear period of clinical examinations every six months and weekly keeping of diary entries during this period.
- Previous pharmacological, surgical and / or orthokeratological therapy of myopia
- Presence of rhinitis sicca
- Previous long-term treatment with atropine
- Presence and / or history of allergic reaction to ophthalmologics (atropine; cycloplegics - cyclopentolate, tropicamide; local anesthetics - eg oxybuprocaine, etc.)
- Presence of strabism, amblyopia, glaucoma, corneal damage and / or corneal scarring and current and / or previous ocular conservative, contactology and / or surgical therapy
- Presence and / or history of general disease (incl. allergy, myasthenia gravis, cardiac, respiratory and / or renal-urological disease and / or dysfunction)
- Presence or scheduled launch of long-term (i.e. longer than 14 days) general and/or local drug therapy and/or scheduled surgical therapy for the participation in the study
- Concomitant use of monoamine oxidase inhibitors (MAOIs)
- Pregnancy, ev. breast feeding
- General diseases, that can lead to myopia (Marfan's, Stickler's syndrome) or affect visual functions (diabetes mellitus, chromosomal anomalies)
The study team makes the final eligibility decision.
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.
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.