The Safety and efficacy of 0.01% Bunazosin Ophthalmic Solution or 0.025% Atropine Ophthalmic Solution for Controlling the Progression of Childhood Myopia

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2024
INTERVENTION: The subjects will be assigned randomly to 0.01% bunazosin alone, 0.025 atropine alone or 0.01% bunazosin plus 0.025% atropine combination, and 1 drop of a allocated drug will be instilled in each eye twice per day, morning and night. This will be observed and examined at 4, 8, 12 and 24 weeks after the start of treatment. CONDITION: Myopia PRIMARY OUTCOME: Safety assessment; 1)Visual acuity (corrected); 2)Intraocular pressure through noncontact tonometry; 3)Ocular alignment; 4)Corneal endothelial cell density; 5)BUT evaluation and periocular skin observation etc. through slit lamp microscope, Finding through fundoscopy; 6)tear reservoir volume (strip meniscometry); 7)Subjective symptoms for dry eye; 8)Morphological/structural retinal evaluation using retinal optical coherence tomography (OCT); 9)Incidence of treatment‐emergent adverse events (TEAEs)and study drug‐related TEAEs SECONDARY OUTCOME: 1)Measurement of cycloplegic objective refraction value (spherical equivalent) using an autorefkeratometer.; 2)Visual acuity chart at visual acuity testing using Landolt ring and measurement of cycloplegic subjective refraction value (SE); 3)Axial length measurement using an optical axial length measurement device; 4)Choroidal thickness measurement for using retinal optical coherence tomography (OCT); 5)Evaluation for retinal function using electroretinogram (ERG) INCLUSION CRITERIA: 1)Japanese children aged 6 to 15 years (elementary school grades 1‐6 and junior high school grades 1‐3) at the time of consent. 2)Children with a cycloplegic objective refraction* spherical equivalent of ‐1.00D to 6.00D in each eye. 3)Children with anisometropia within ‐1.00D. 4)Children with astigmatism within ‐ 1.50D. 5)Children with corrected visual acuity of at least 1.2 in each eye. 6)Children with no intraocular pressure abnormalities (within 20 mmHg) 7)Children capable of undergoing cycloplegia. 8)Children who can undergo outpatient examinations per protocol. 9)Written informed consent to participate in the study obtained from a person with parental authority. In addition, written assent mandatory to participate in the study obtained from the junior high school children personally with parental authority, and written assent to participate in the study obtained from the elementary school children personally with parental authority where
Epistemonikos ID: 50bb04faf2ee6375cdd328d1865c979aee5b7413
First added on: Aug 28, 2024