JPRN-jRCTs051190125已完成未知
A Randomized, Single-Blind, Multicenter, Active-Controlled Crossover Study to Assess Efficacy and Safety of the Combination Therapy of Prostaglandin Analogs and Brimonidine/Timolol Fixed Combination for Open Angle Glaucoma or Ocular Hypertension
Inatani Masaru0 个研究点目标入组 110 人开始时间: 2020年3月27日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 110
研究概览
简要总结
The concomitant use of BTFC with prostaglandin analogs lowered intraocular pressure by 3.55 mmHg, verifying that BTFC was non-inferior to DTFC. Tolerability is significantly higher in BTFC, and significantly more patients chose BTFC in regard to comfort compared to DTFC.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1)Patients with written informed consent obtained after adequate explanation on participating the study
- •2)Male or female outpatient, 20 years of age or older
- •3)Patients with open angle glaucoma (primary open angle glaucoma or exfoliation glaucoma) or ocular hypertension in the study eye
- •4)Patients who have continued to instill the same prostaglandin analog into the study eye more than 90 days
- •5)Patients with IOP between 15.0 mmHg and 24.0 mmHg in the study eye at the initiation of the evaluation period (Visit1)
- •6)Patients with IOP range within 3 mmHg in past 90 days in the case of exfoliation glaucoma
- •7)Patients with required additional IOP-lowering treatment
- •8)Patients with IOP of 24.0 mmHg or lower for both eyes
- •9)Patients with best corrected visual acuity of 0.3 or better for both eyes
排除标准
- •1)Patients who have instilled the drug for glaucoma except prostaglandin analogs in the study eye or have used corticosteroid agent within past 28 days of Visit1
- •2)Patients with history of surgery for glaucoma with the study eye
- •3)Patients with history of intraocular surgery within past 90 days of Visit1 with the study eye
- •4)Patients with intraocular injection, sub-Tenon or subconjunctival injection of a triamcinolone acetonide within past 180 days of Visit1 with the study eye
- •5)Patients with any active retinal disease which may progress during the study in the eye instilled with test drug
- •6)Patients with any active ocular disease other than primary open-angle glaucoma or ocular hypertension in the eye instilled with test drug
- •7)Patients with a serious systemic disease
- •8)Patients with severe visual field defect with the study eye
- •9)Patients with corneal abnormality which is considered to preclude accurate measurement of IOP by Goldmann applanation tonometer with the study eye
- •10)Patients with history of corneal transplantation or keratorefractive surgery with the study eye
- •11)Patients with contraindications or patients in whom precautions are required for the use of BTFC or Dorzolamide/Timolol fixed combination (DTFC)
- •12)Women who are pregnant, lactating or may be pregnant, or planning to be pregnant during the study period, or cannot agree to contraception
- •13)Patients who have been administered investigational drug within past 90 days of Visit1
- •14)Patients who are planning to receive prohibited concomitant drugs during the study period
- •15)Patients who have been considered inappropriate as study subjects by doctor
研究者
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