Actively Recruiting
Study to Evaluate the Efficacy of Alleance® (Atropine Sulfate 0.01%) as a Treatment to Delay Myopia and Axial Ocular Elongation in Children.
Led by Laboratorios Sophia S.A de C.V. · Updated on 2025-03-21
123
Participants Needed
1
Research Sites
137 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phase III clinical study to evaluate the efficacy of Alleance® (atropine sulfate 0.01%) ophthalmic solution through the incidence of unexpected adverse events, changes in Best Corrected Visual Acuity (BCVA), changes in intraocular pressure, changes in the amplitude of accommodation, compared to placebo, as a treatment to delay the progression of myopia and axial ocular elongation in children.
CONDITIONS
Official Title
Study to Evaluate the Efficacy of Alleance® (Atropine Sulfate 0.01%) as a Treatment to Delay Myopia and Axial Ocular Elongation in Children.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged between 3 to 12 years
- Male or female sex
- Parent(s) or legal guardian(s) must provide signed informed consent
- Children 7 years or older must give written agreement to participate; for younger children, verbal agreement is respected
- Ability and willingness to follow scheduled visits, treatment, and study procedures
- Female children who have started menstruating must have a negative urine pregnancy test at screening
- Females who have started menstruating must use effective contraception during the study
- Refractive error of spherical equivalent between -0.50 to -6.00 diopters in each eye
- Astigmatism less than -1.50 diopters in each eye
- Spherical equivalent anisometropia of 1.50 diopters or less
- Best corrected visual acuity normal for age
- Normal binocular function and stereopsis for age
- Normal intraocular pressure (less than 21 mmHg)
- Gestational age of at least 32 weeks and birth weight over 1500 grams
You will not qualify if you...
- Allergy to atropine or any investigational product components
- Previous or current use of atropine or optical methods for myopia control except frame lenses or monofocal contact lenses
- History or current amblyopia or manifest strabismus
- Persistent heart rate over 120 beats per minute at screening
- History of diseases predisposing to severe myopia (e.g., Marfan syndrome, Stickler syndrome, retinopathy of prematurity)
- Serious systemic diseases judged by investigator to cause ineligibility
- History or current glaucoma or ocular hypertension
- History of refractive ocular anatomical anomalies
- History of ocular diseases excluding myopia
- History of any ocular surgery
- Pregnant or breastfeeding females who have started menstruating
- Participation in clinical research studies within 30 days prior to this study
- Previous participation in this study
- Unresolved ocular lesions or trauma at study entry
- Active inflammatory or infectious ocular disease at study entry
- Surgical procedures outside ophthalmology within last 3 months
- Chronic use of antimuscarinic/anticholinergic medications within 21 days prior or needed during study
- Immediate family member is part of research site or sponsor staff
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Innovación Y Desarrollo En Ciencias de La Salud S de Rl de Cv
Mexico City, Mexico, 14090
Actively Recruiting
Research Team
A
Alejandra Sanchez-Rios, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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