Table 1.

Eligibility and exclusion criteria.

Eligibility criteria

Age 18–60 years, male or femaleDiagnosed with amblyopia due to myopic or hyperopic anisometropia, or, congenital esotropia Visual acuity in the amblyopic eye ≥0.30 and <1.10 logMARVisual acuity in the dominant eye ≤0.10 logMARAnisometropia ≤4.25 (spherical equivalent in diopters)Judged to be otherwise healthy by the Investigator, based on medical history, brief physical examination,    eye examination and clinical laboratory assessmentsFemales of childbearing potential were eligible for the study provided (i) they have a negative urine    pregnancy test at the screening visit and (ii) they agreed to use adequate contraception (e.g. oral, depot    or implanted hormonal contraception, intrauterine device, surgical sterilization or partner vasectomy)    from the screening visit until at least 4 weeks after the last dose of study medication

Exclusion criteria

Diagnosed with other reasons of strabismus (than infantile esotropia) as the primary reason for    amblyopiaHistory of any amblyopia therapy in the 2 years before the screening visitAny eye surgery less than 6 months before the screening visitObserved off-fixation by ophthalmological examination (extra-foveal/eccentric fixation)Other ophthalmological pathologies that may affect the patient’s rehabilitationPregnant, planning to become pregnant during the study, or breast feedingHistory of depressive illness or treatment with antidepressant medication within 6 months before the    screening visitUse of psychiatric medication within 6 months before the screening visitReceipt of an experimental treatment for any disease within 4 weeks before the screening visitHistory or presence of illicit drug use or alcohol abuseHistory or presence of any medical or psychiatric condition or disease, or laboratory abnormality that, in    the opinion of the Investigator, may place the patient at unacceptable risk or that could prevent the    patient from completing the study