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Tests treatment safety and results for Myopia
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.
ClinicalTrials.gov ID: NCT06389110
What this study is testing
What is Alleance®?
Alleance® is an investigational medicine, being studied as a potential treatment for 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
- 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.
- Phase 3: a large, late-stage study
- 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 12. Healthy volunteers may be eligible.
You may be able to join if
- Children aged between 3 to 12 years
- Male or female sex.
- The parent(s) or legal guardian(s) must voluntarily give their signed informed consent.
- From the age of 7 years and older, the subject's willingness to participate in the research study will be expressed in writing. In the case of people...
- Ability and willingness to comply with the scheduled visits, treatment plan and other study procedures.
You likely can't join if
- Allergy to atropine or any of the components of the investigational products.
- Previous or current use of atropine, orthokeratology lens or other optical methods for myopia control (bifocal, progressive, multifocal, or...
- Heart rate \> 120 beats per minute persistently (for more than 10 minutes) at the time of screening/baseline visit.
- History of any disease or syndrome predisposing the subject to severe myopia (Marfan syndrome, Stickler syndrome, retinopathy of prematurity, etc.).
- History of serious systemic disease that, in the investigator's judgment, would make the subject ineligible (e.g., cardiac, endocrine, respiratory...
- History or current history of glaucoma or ocular hypertension.
See the full eligibility criteria
- Children aged between 3 to 12 years
- Male or female sex.
- The parent(s) or legal guardian(s) must voluntarily give their signed informed consent.
- From the age of 7 years and older, the subject's willingness to participate in the research study will be expressed in writing. In the case of people under 7 years of age, only the signature of the informed consent by...
- Ability and willingness to comply with the scheduled visits, treatment plan and other study procedures.
- Female people, who have already presented their menarche, must have a negative urine pregnancy test at the time of screening.
- Female people who have already experienced menarche should secure a method of contraception for the duration of the study. Acceptable contraceptive methods include abstinence (defined as abstinence from heterosexual...
- Refractive error of spherical equivalent between -0.50 to -6.00 D in each eye, measured by autorefraction and cycloplegic retinoscopy.
- Astigmatism less than -1.50 D in each eye, measured by autorefraction and retinoscopy.
- Spherical equivalent anisometropia ≤ 1.50 D measured by autorefraction and cycloplegic retinoscopy.
- Best corrected visual acuity (BCVA) normal for age.
- Normal binocular function and stereopsis for age.
- Normal intraocular pressure (\< 21 mmHg).
- Gestational age ≥ 32 weeks and birth weight \> 1500 g.
- Allergy to atropine or any of the components of the investigational products.
- Previous or current use of atropine, orthokeratology lens or other optical methods for myopia control (bifocal, progressive, multifocal, or defocusing air or contact lenses). Only prior or current use of frame lenses or...
- Heart rate \> 120 beats per minute persistently (for more than 10 minutes) at the time of screening/baseline visit.
- History of any disease or syndrome predisposing the subject to severe myopia (Marfan syndrome, Stickler syndrome, retinopathy of prematurity, etc.).
- History of serious systemic disease that, in the investigator's judgment, would make the subject ineligible (e.g., cardiac, endocrine, respiratory, neurologic [infantile cerebral palsy], Down syndrome, etc.).
- History or current history of glaucoma or ocular hypertension.
- History of any refractive ocular anatomical anomaly (keratoconus, lenticonus, spherophakia, aphakia, etc.).
- History of ocular diseases, excluding myopia (corneal alterations/opacities, cataract, retinal alterations, inflammatory diseases, etc.).
- History of any type of ocular surgery.
- For female people who have presented their menarche: being pregnant or breastfeeding.
- Having participated in clinical research studies 30 days prior to inclusion in the present study.
- Previous participation in this study.
- Present unresolved ocular lesions or trauma at the time of study entry.
- Present active inflammatory or infectious ocular disease at the time of study entry.
- Having undergone surgical procedures, not ophthalmologic, within the last 3 months.
- Chronic use of any topical or systemic antimuscarinic/anticholinergic medication (atropine, scopolamine, tropicamide) within 21 days prior to screening, and/or anticipated need for its chronic use during the study...
- Be or have an immediate family member (e.g., parent/legal guardian or sibling) who is part of the research site or sponsor´s staff. Elimination Criteria:
- Withdrawal of their consent to participate in the study (informed consent form).
- Occurrence of a serious adverse event, whether related or not to the interventions, that in the opinion of the principal investigator (PI) and/or the sponsor, could affect the patient's fitness to safely continue with...
- Non-side effects or hypersensitivity to any of the compounds used during the tests -(fluorescein, tetracaine).
- Non-side effects or hypersensitivity to any of the drugs under investigation.
- Adherence \< 80% determined by the subject's diary and corroborated by the final weight of the research products (RP) compared to the initial weight.
The study team makes the final eligibility decision.
Where it's taking place
- Mexico City, Mexico
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, 3 years to 12 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico City, Mexico. 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.