Human Vitreous Concentration of Brimonidine after Instillation of Ailamide Combination Ophthalmic Suspension

JRCT ID: jRCTs051200089

Registered date:25/11/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Idiopathic epiretinal membrane, macular hole
• Date of first enrollment: 30/11/2020
• Target sample size: 10
• Study type: Interventional
• Intervention(s): One drop of Brimonidine/Brinzolamide fixed combination ophthalmic suspension is instilled twice-daily for 8 days (7 days before surgery and the operation day in the morning and at 2h before surgery).

Outcome(s)

• Primary Outcome: Concentration of brimonidine in the aqueous humor and vitreous
• Secondary Outcome: Concentration of brinzolamide in the aqueous humor and vitreous, Correlation between concentration of drugs in the aqueous humor and vitreous and patient background , ocular fundus (blood vessel), adverse events, visual acuity, intraocular pressure, ophthalmologic findings (cornea, conjunctiva)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Patients with written informed consent obtained after adequate explanation on participating the study
2)Male or female,20 years of age or older
3)Patients who undergo vitrectomy for idiopathic epiretinal membrane or macular hole

Exclude criteria

1)Patients with ocular inflammation
2)Patients with vitreous hemorrhage
3)Patients with proliferative diabetic retinopathy
4)Patients with severe corneal epithelium disorder
5)Patients with contraindications or patients in whom precautions are required for the use of Brimonidine/ Brinzolamide fixed combination.
6)Patients with a history of serious side effects against alpha 2-adrenergic receptor agonist or carbonic anhydrase inhibitor
7)Women who are pregnant, lactating or may be pregnant, or planning to be pregnant during the study period, or can not agree to contraception
8)Patients who have been considered inappropriate as study subjects by doctor

Related Information

• Primary Sponsor: Inatani Masaru
• Secondary Sponsor: Senju Pharmaceutical Co.,Ltd.