Study to Evaluate the Efficacy of Alleance® (Atropine Sulfate 0.01%) as a Treatment to Delay Myopia and Axial Ocular Elongation in Children.

NCT06389110 | Recruiting Phase 3 DMC

• 1 other identifier: SOPH201-1023/III
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief 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 to delay the progression of myopia and axial ocular elongation in children.

Conditions

Myopia; Myopia, Progressive

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  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

  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

  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

  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)

  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

  Days 0 (Basal visit), 14 (Visit 1), 180 (Visit 3), 365 (Final Visit), 380 (Last Final Safety call)

Study Arms (2)

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

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

Drug: Placebo

Interventions

Alleance® DRUG

Atropine sulfate 0.01%, ophthalmic solution.

Alleance®

Placebo DRUG

Ophthalmic solution.

Placebo

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify 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 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.
• 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.

You may not qualify 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 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.).
• 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.
• 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.

Sponsors & Collaborators

• Laboratorios Sophia S.A de C.V.: lead

Study Sites (1)

Innovación Y Desarrollo En Ciencias de La Salud S de Rl de Cv

Mexico City, 14090, Mexico

RECRUITING

MeSH Terms

Conditions

Myopia; Myopia, Degenerative

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Alejandra Sanchez-Rios, MD

CONTACT

33 3001 4200; alejandra.sanchez@sophia.com.mx

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a study to demonstrate superiority, double-blind, randomized, controlled, comparative, and multicenter phase III clinical trial.

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: April 29, 2024
• Study Start: March 15, 2025
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)