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

JRCT ID: jRCTs031230616

Registered date:06/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Myopia
• Date of first enrollment: 06/02/2024
• Target sample size: 15
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

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)

Key inclusion & exclusion criteria

• Age minimum: >= 6age old
• Age maximum: <= 15age old
• Gender: Both

Include 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 wherever possible.
*Cycloplegic objective refraction: Following topical anesthesia, 1 drop of cyclopentolate ophthalmic solution (Cyplegin 1% ophthalmic solution) is administered to each eye, with a second drop administered after 5 minutes. Measurements are conducted after a one-hour interval.

Exclude criteria

1)Children with abnormal visual function bilaterally.
2)Children with amblyopia or manifest strabismus.
3)Children with difference in objective spherical equivalent with and without cycloplegia of more than 1.00D in each eye.
4)Children with ocular disorders other than myopia.
5)Children with ocular or systemic disorders that potentially affect myopia or refractive power.
6)Children who have received previous treatment for myopia that included atropine therapy such as contact lenses, bifocal lenses, or progressive lenses with atropine therapy (however, this does not apply to children who discontinued 0.4% tropicamide ophthalmic solution at least 3 months previously).
7)Children who have received bunazosin.
8)Children who are concurrent use of anticholinergic agent (tricyclic or tetracyclic antidepressive agent, phenothiazine derivatives and preparations and antihistamine agent).
9)Children with a history of cardiovascular or respiratory disease.
10)Children who have received pharmacotherapy for asthma in the past year.
11)Children with a history of allergy to bunazosin, atropine, cyclopentolate, or benzalkonium.
12)Children with a history of allergy to belladonna alkaloid.
13)Children who cannot instill medication into the eye.
14)Children who may require contact lenses, bifocal lenses, or progressive lenses during the clinical study period.
15)Children deemed otherwise unsuitable for the study by the investigator.

Related Information

• Primary Sponsor: Mori Kiwako
• Source(s) of Monetary Support: Tsubota Laboratory, Inc.