Trial · NCT06389110
Study to Evaluate the Efficacy of Alleance® (Atropine Sulfate 0.01%) as a Treatment to Delay Myopia and Axial Ocular Elongation in Children.
NCT06389110, Phase 3, Recruiting, Laboratorios Sophia S.A de C.V.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate the Efficacy of Alleance® (Atropine Sulfate 0.01%) as a Treatment to Delay Myopia and Axial Ocular Elongation in Children. Trials, record NCT06389110. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06389110
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Efficacy of Alleance® (Atropine Sulfate 0.01%) as a Treatment to Delay Myopia and Axial Ocular Elongation in Children.
- NCT number
- NCT06389110
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 123 participants, estimated
- Lead sponsor
- Laboratorios Sophia S.A de C.V.
- Conditions
- Myopia, Myopia, Progressive
- Interventions
- Alleance®, Placebo
- First posted
- 2024-04-29
- Last updated
- 2025-03-21
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in the spherical equivalent | 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 |
| Primary | Changes in axial eye length | 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. |
| Secondary | 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) | Any unfavorable medical condition affecting the subject after the administration of the investigation product, related to such intervention. |
| Secondary | Incidence of photophobia between interventions | Days 0 (Basal visit), 14 (Visit 1), 180 (Visit 3), 365 (Final Visit), 380 (Last Final Safety call) | 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. |
| Secondary | 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) | The changes in pupillary diameter will be evaluated through the optical biometer or by the OPD scan Topographer III®. |
| Secondary | 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) | 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. |
| Secondary | 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) | 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 |
| Secondary | Changes in the amplitude of accommodation (AA) between interventions | Days 0 (Basal visit), 14 (Visit 1), 180 (Visit 3), 365 (Final Visit), 380 (Last Final Safety call) | 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. |
| Secondary | Changes in intraocular pressure (IOP) | Days 0 (Basal visit), 14 (Visit 1), 180 (Visit 3), 365 (Final Visit), 380 (Last Final Safety call) | Previous instillation of topical anesthetic, the IOP (both eyes) will be measured through a Goldmann tonometer during visits. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06389110
GET https://conductscience.org/api/trials/v1/NCT06389110/registered