MyopiaPhase 3NCT06389110
Study to Evaluate the Efficacy of Alleance® (Atropine Sulfate 0.01%) as a Treatment to Delay Myopia and Axial Ocular Elongation in Children.
A Phase 3 study testing Alleance® in people with Myopia and Myopia, Progressive, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 3 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Myopia, Progressive
- What is being tested?
- Alleance®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 1 siteMexico
- Study dates
- 15 Mar 2025to 30 Oct 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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 subjects under 7 years of age, only the signature of the informed consent by the parent(s) or legal guardian(s) will be required, provided that the subject's verbally expressed will is respected.
- Ability and willingness to comply with the scheduled visits, treatment plan and other study procedures.
- Female subjects, who have already presented their menarche, must have a negative urine pregnancy test at the time of screening.
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- Female subjects 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 intercourse from study entry until completion) or use of a highly effective contraceptive method, including hormonal contraception, barrier methods or intrauterine device).
- 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.
Who cannot join
- 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 monofocal contact lenses for the correction of myopic or myopic/astigmatic refractive error will be allowed.
- History or current history of amblyopia or manifest strabismus, including intermittent tropia.
- 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.).
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- 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 subjects 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 period (more than 7 consecutive days in a month or more than 30 days total in a year). The use of cycloplegic drops for ophthalmologic examination is allowed.
- 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 the study procedures.
- Non-tolerability or hypersensitivity to any of the compounds used during the tests -(fluorescein, tetracaine).
- Non-tolerability 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Innovación Y Desarrollo En Ciencias de La Salud S de Rl de Cv
Mexico City, 14090
Santiago Brizuela Pavón
About this study
Official title: Phase III Clinical Study to Evaluate the Efficacy of Alleance® (Atropine Sulfate 0.01%) as a Treatment to Delay the Progression of Myopia and Axial Ocular Elongation in Children.
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.
Read the detailed description
This is a study to demonstrate superiority, double-blind, randomized, controlled, comparative, and multicenter phase III clinical trial.
Primary Objective:
- To demonstrate the superiority of Alleance® compared to placebo in delaying myopia progression in children.
Specific objectives:
- To demonstrate the reduction in progression in spherical equivalent in children using Alleance® compared to placebo after 12 months of treatment.
- To demonstrate the reduction in progression in ocular axial length in children using Alleance® compared to placebo, after 12 months of treatment.
Secondary objectives:
- To compare the incidence of adverse events related to the interventions.
- Compare the incidence of photophobia between interventions.
- To assess pupillary diameter between the interventions.
- To assess best-corrected far visual acuity between interventions.
- To assess near best-corrected visual acuity between interventions.
- To assess the amplitude of accommodation between interventions.
- Assess intraocular pressure (IOP) between procedures.
- Conditions
- Myopia, Myopia, Progressive
- Being tested
- Alleance®, Placebo
- Medical subject headings
- Myopia, Myopia, Degenerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alleance®Drug
Atropine sulfate 0.01%, ophthalmic solution.
PlaceboDrug
Ophthalmic solution.
| Study group | Role | What they receive |
|---|---|---|
| Alleance® | Active comparator | Alleance®. Atropine sulfate 0.01%. Ophthalmic solution.
* Dosage: 1 drop QD [1] (once a day), at night, for 12 months.
* Route of administration: Ophthalmic Receives: Drug: Alleance® |
| Placebo | Placebo comparator | * Placebo. Ophthalmic solution.
* Dosage: 1 drop QD [1] (once a day), at night, for 12 months.
* Route of administration: Ophthalmic Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the spherical equivalent
The reduction in progression in spherical equivalent, will be calculated by combining the spherical component (E) and the cylindrical component (C) of the refractive error, independently for each eye: EE=E+C2
Measured: Days 0 (Basal visit), 14 (Visit 1), 45 (Safety call 1), 180 (Visit 3), 225 (Safety call 2), 270(Visit 4), 315 (Safety call 4), 365 (Final Visit), 380 (Last Final Safety call)
Changes in axial eye length
The reduction in progression in ocular axial length will be measured utilizing optical biometry.
Measured: Days 0 (Basal visit), 14 (Visit 1), 45 (Safety call 1), 180 (Visit 3), 225 (Safety call 2), 270(Visit 4), 315 (Safety call 4), 365 (Final Visit), 380 (Last Final Safety call)
Secondary outcomes (7)
Incidence of unexpected adverse events related to the interventions
Any unfavorable medical condition affecting the subject after the administration of the investigation product, related to such intervention.
Measured: Days 0 (Basal visit), 14 (Visit 1), 45 (Safety call 1), 180 (Visit 3), 225 (Safety call 2), 270(Visit 4), 315 (Safety call 4), 365 (Final Visit), 380 (Last Final Safety call)
Incidence of photophobia between interventions
Any signs of uncomfortable vision, based on the diffusion of light through the ocular media or on a transient or permanent lack of adaptation. The subjects will be questioned regarding this symptoms' incidence.
Measured: Days 0 (Basal visit), 14 (Visit 1), 180 (Visit 3), 365 (Final Visit), 380 (Last Final Safety call)
Changes in pupillary diameter between the interventions
The changes in pupillary diameter will be evaluated through the optical biometer or by the OPD scan Topographer III®.
Measured: Days 0 (Basal visit), 14 (Visit 1), 180 (Visit 3), 365 (Final Visit), 380 (Last Final Safety call)
Changes in Best Corrected Visual Acuity (BCVA)
The best corrected visual acuity will be evaluated through the Snellen chart in subjects ≥ 6 years of age.
The LEA chart is used to assess visual acuity in children older than 30 months of age.
Measured: Days 0 (Basal visit), 14 (Visit 1), 180 (Visit 3), 365 (Final Visit), 380 (Last Final Safety call)
Changes in near best-corrected visual acuity
The bear best corrected visual acuity will be evaluated through the LEA chart, in subjects ≤ 5 years of age. The bear best corrected visual acuity will be evaluated through the Snellen chart in subjects ≥ 6 years of age.
The LEA chart is used to assess visual acuity in children older than 30 months of age
Measured: Days 0 (Basal visit), 14 (Visit 1), 180 (Visit 3), 365 (Final Visit), 380 (Last Final Safety call)
Changes in the amplitude of accommodation (AA) between interventions
The amplitude of accommodation(AA) is the difference between the resting state of the crystalline lens (far point) and the maximum refractive focus in diopters that the emmetropic or emmetropic patient can use to focus on near objects.
The AA will be measured by the Donders method or by the approach method, utilizing the LEA chart.
Measured: Days 0 (Basal visit), 14 (Visit 1), 180 (Visit 3), 365 (Final Visit), 380 (Last Final Safety call)
Changes in intraocular pressure (IOP)
Previous instillation of topical anesthetic, the IOP (both eyes) will be measured through a Goldmann tonometer during visits.
Measured: Days 0 (Basal visit), 14 (Visit 1), 180 (Visit 3), 365 (Final Visit), 380 (Last Final Safety call)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start15 Mar 2025
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a study to demonstrate superiority, double-blind, randomized, controlled, comparative, and multicenter phase III clinical trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 123 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratorios Sophia S.A de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389110
- Sponsor's protocol ID
- SOPH201-1023/III
- Status last verified
- Mar 2025
- First submitted
- 24 Apr 2024
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Clinical Study to Evaluate the Efficacy of Alleance® (Atropine Sulfate 0.01%) as a Treatment to Delay the Progression of Myopia and Axial Ocular Elongation in Children.
- ClinicalTrials.gov ID
- NCT06389110
- Acronym / sponsor ID
- SOPH201-1023/III
- Conditions
- Myopia, Myopia, Progressive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 123 participants (estimated)
- Lead sponsor
- Laboratorios Sophia S.A de C.V.Industry (pharma, biotech, devices)
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a study to demonstrate superiority, double-blind, randomized, controlled, comparative, and multicenter phase III clinical trial.
Primary Objective:
- To demonstrate the superiority of Alleance® compared to placebo in delaying myopia progression in children.
Specific objectives:
- To demonstrate the reduction in progression in spherical equivalent in children using Alleance® compared to placebo after 12 months of treatment.
- To demonstrate the reduction in progression in ocular axial length in children using Alleance® compared to placebo, after 12 months of treatment.
Secondary objectives:
- To compare the incidence of adverse events related to the interventions.
- Compare the incidence of photophobia between interventions.
- To assess pupillary diameter between the interventions.
- To assess best-corrected far visual acuity between interventions.
- To assess near best-corrected visual acuity between interventions.
- To assess the amplitude of accommodation between interventions.
- Assess intraocular pressure (IOP) between procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a study to demonstrate superiority, double-blind, randomized, controlled, comparative, and multicenter phase III clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Alleance® | Active comparator | Drug: Alleance®Alleance®. Atropine sulfate 0.01%. Ophthalmic solution. * Dosage: 1 drop QD [1] (once a day), at night, for 12 months. * Route of administration: Ophthalmic |
| Placebo | Placebo comparator | Drug: Placebo* Placebo. Ophthalmic solution. * Dosage: 1 drop QD [1] (once a day), at night, for 12 months. * Route of administration: Ophthalmic |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- 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 subjects under 7 years of age, only the signature of the informed consent by the parent(s) or legal guardian(s) will be required, provided that the subject's verbally expressed will is respected.
- Ability and willingness to comply with the scheduled visits, treatment plan and other study procedures.
Key exclusion criteria (24 listed)
- 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 monofocal contact lenses for the correction of myopic or myopic/astigmatic refractive error will be allowed.
- History or current history of amblyopia or manifest strabismus, including intermittent tropia.
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alleance®Atropine sulfate 0.01%, ophthalmic solution. | Drug | Alleance® |
| PlaceboOphthalmic solution. | Drug | Placebo |
Primary outcome
Changes in the spherical equivalent
Time frame: Days 0 (Basal visit), 14 (Visit 1), 45 (Safety call 1), 180 (Visit 3), 225 (Safety call 2), 270(Visit 4), 315 (Safety call 4), 365 (Final Visit), 380 (Last Final Safety call)
The reduction in progression in spherical equivalent, will be calculated by combining the spherical component (E) and the cylindrical component (C) of the refractive error, independently for each eye: EE=E+C2
Changes in axial eye length
Time frame: Days 0 (Basal visit), 14 (Visit 1), 45 (Safety call 1), 180 (Visit 3), 225 (Safety call 2), 270(Visit 4), 315 (Safety call 4), 365 (Final Visit), 380 (Last Final Safety call)
The reduction in progression in ocular axial length will be measured utilizing optical biometry.
7 secondary outcomes
Incidence of unexpected adverse events related to the interventions
Time frame: Days 0 (Basal visit), 14 (Visit 1), 45 (Safety call 1), 180 (Visit 3), 225 (Safety call 2), 270(Visit 4), 315 (Safety call 4), 365 (Final Visit), 380 (Last Final Safety call)
Incidence of photophobia between interventions
Time frame: Days 0 (Basal visit), 14 (Visit 1), 180 (Visit 3), 365 (Final Visit), 380 (Last Final Safety call)
Changes in pupillary diameter between the interventions
Time frame: Days 0 (Basal visit), 14 (Visit 1), 180 (Visit 3), 365 (Final Visit), 380 (Last Final Safety call)
Changes in Best Corrected Visual Acuity (BCVA)
Time frame: Days 0 (Basal visit), 14 (Visit 1), 180 (Visit 3), 365 (Final Visit), 380 (Last Final Safety call)
Changes in near best-corrected visual acuity
Time frame: Days 0 (Basal visit), 14 (Visit 1), 180 (Visit 3), 365 (Final Visit), 380 (Last Final Safety call)
Changes in the amplitude of accommodation (AA) between interventions
Time frame: Days 0 (Basal visit), 14 (Visit 1), 180 (Visit 3), 365 (Final Visit), 380 (Last Final Safety call)
Changes in intraocular pressure (IOP)
Time frame: Days 0 (Basal visit), 14 (Visit 1), 180 (Visit 3), 365 (Final Visit), 380 (Last Final Safety call)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alleance® in people with Myopia and Myopia, Progressive, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alejandra Sanchez-Rios, MD (33 3001 4200, alejandra.sanchez@sophia.com.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the spherical equivalent (time frame: Days 0 (Basal visit), 14 (Visit 1), 45 (Safety call 1), 180 (Visit 3), 225 (Safety call 2), 270(Visit 4), 315 (Safety call 4), 365 (Final Visit), 380 (Last Final Safety call)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.