A phase III, randomized, double blind, multiple doses, placebo-controlled parallel-group, adaptive study to evaluate the efficacy of atropine to treat the progression of myopia in children and adolescents from 3 to less than 18 years of age (MODERATO Study)

Conditions

Myopia

Brief summary

Mean annual rate of progression of myopia (D/year) based on spherical equivalent (SE) measured by cycloplegic autorefraction through 24 months.

Detailed description

Number and percentage of early escape patients at 6 months., Mean change in axial length and glasses prescription at 3, 6, 12, 18 and 24 months., Safety at 3, 6, 12, 18 and 24 months, measuring: % children requiring photochromic and/or varifocal lenses counts and percentage of patients reporting any AEs change in photosensitivity index best corrected distance and near visual acuity pupil size and accommodation amplitude, Vision-related quality of life., Acceptability of the formulation: it will be assessed with a 3-item questionnaire, scored on a six-point scale., Overall between-group difference from baseline in the proportion of subjects who show < -0.50 D myopia progression (Spherical Equivalent Refraction, SER) at 24 months: Chi-square test, or Fisher's exact test, will be used to test for differences among three treatment groups in the proportion of subjects who show < -0.50 D myopia progression (SER) at 24 months.

Related papers

No related papers found yet.

Interventions

DRUGAtropine Eye Drops

DRUGSolution (0.025% w/v)

DRUGThe placebo consists of the same composition as the atropine eye drops except for the active substance.

DRUGSolution (0.05% w/v)

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Mean annual rate of progression of myopia (D/year) based on spherical equivalent (SE) measured by cycloplegic autorefraction through 24 months.	—

Secondary

Measure	Time frame
Number and percentage of early escape patients at 6 months., Mean change in axial length and glasses prescription at 3, 6, 12, 18 and 24 months., Safety at 3, 6, 12, 18 and 24 months, measuring: % children requiring photochromic and/or varifocal lenses counts and percentage of patients reporting any AEs change in photosensitivity index best corrected distance and near visual acuity pupil size and accommodation amplitude, Vision-related quality of life., Acceptability of the formulation: it will be assessed with a 3-item questionnaire, scored on a six-point scale., Overall between-group difference from baseline in the proportion of subjects who show < -0.50 D myopia progression (Spherical Equivalent Refraction, SER) at 24 months: Chi-square test, or Fisher's exact test, will be used to test for differences among three treatment groups in the proportion of subjects who show < -0.50 D myopia progression (SER) at 24 months.	—

Measure

Time frame

Number and percentage of early escape patients at 6 months., Mean change in axial length and glasses prescription at 3, 6, 12, 18 and 24 months., Safety at 3, 6, 12, 18 and 24 months, measuring: % children requiring photochromic and/or varifocal lenses counts and percentage of patients reporting any AEs change in photosensitivity index best corrected distance and near visual acuity pupil size and accommodation amplitude, Vision-related quality of life., Acceptability of the formulation: it will be assessed with a 3-item questionnaire, scored on a six-point scale., Overall between-group difference from baseline in the proportion of subjects who show < -0.50 D myopia progression (Spherical Equivalent Refraction, SER) at 24 months: Chi-square test, or Fisher's exact test, will be used to test for differences among three treatment groups in the proportion of subjects who show < -0.50 D myopia progression (SER) at 24 months.

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Countries

Italy, Poland, Spain

Outcome results

None listed