Comparison of Efficacy and Ocular Surface Disease Assessment Between BRIDIN- PLUS® Eye Drops and COMBIGAN® Eye Drops in Glaucoma or Ocular Hypertensive Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Questionnaire (Evaluation of Satisfaction with Medication, Ocular tolerance)
研究概览
简要总结
Comparison of Efficacy and Ocular Surface Disease Assessment between BRIDIN-plus Eye drops and Combigan Eye drops in Glaucoma or Ocular Hypertensive Patients : Phase 4, Parallel Group Design, Investigator-blind, Active-control, Randomized, Multi-center Trial
详细描述
The purpose of this clinical trial is to prove lower negative effects on ocular surface disease and higher patient compliance of a single-use formula BRIDIN-PLUS® eye drops group, comparing to a multi-use formula COMBIGAN® eye drops after 12 weeks of administration to glaucoma or ocular hypertensive patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •A patient with primary close angle glaucoma, congenital glaucoma, secondary glaucoma caused by steroids
- •Best corrected visual acuity of both eyes measured by Snellen acuity charts is 20/80 (decimal 0.25) or less
- •A patient with progressive intraocular inflammation
- •Central corneal thickness is less than 470um or greater than 591ums
- •A patient who has had lacrimal punctual occlusion done within the last 3 monthds or who has eye surgery plan during the clinical study
- •Pregnant or lactating women
- •Other cases if investigators judge the patient is difficult to participate the clinical trial
研究组 & 干预措施
BRIDIN-plus Eye drops
One drop in the eyes, twice a day, approximately 12 hours apart.
干预措施: BRIDIN-plus Eye drops (Drug)
Combigan Eye drops
One drop in the eyes, twice a day, approximately 12 hours apart.
干预措施: Combigan Eye drops (Drug)
结局指标
主要结局
Questionnaire (Evaluation of Satisfaction with Medication, Ocular tolerance)
时间窗: 12 weeks after administration
treatment administration satisfaction and ocular tolerance are evaluated through questionnaires. Treatment administration satisfaction questionnaire includes the convenience of use and storage of investigational products and ocular tolerance evaluation questionnaire includes symptom severity(0\~3) and symptom duration(briefly, persistent) for 8 symptoms of stinging/burning, sticky eyes, itching, blurred vision, foreign-body sensation, dryness, photophobia, pain. Medication compliance is evaluated with MGL-MAQ-Korean version.
Corneal staining test
时间窗: 12 weeks after administration
Corneal staining score is evaluated according to the oxford grading system after blue fluorescein staining under a slit lamp biomicroscope of cobalt blue light source using a yellow filter. Corneal surface is divided into 3 areas and evaluated from grade 0 indicating that there is no staining to grade 5 indicating denser staining due to severe corneal defect. (The score ranges from 0 to 5, with higher scores indicate worse symtoms.)
Conjunctival staining test
时间窗: 12 weeks after administration
Conjunctival staining score is evaluated after blue fluorescein staining under a slit lamp biomicroscope, by NEI(The National Eye Institute) scale. Conjunctival surface is divided into 6 areas and evaluated from grade 0 indicating that there is no staining to grade 3 indicating denser staining due to severe conjunctival defect.
Ocular surface disease index (OSDI)
时间窗: 12 weeks after administration
Ocular surface disease index include 12 items comprising of assessment of vision related functioning (5 items), ocular symptoms(4 items) and environmental factors that may cause symptoms (3 items). Each item is 5-point Likert scale in which a higher score indicates more severe symptoms. A total score is classified as normal (0-12), mild (13-22), moderate (23-32) and severe (33 or more) and it is evaluated based on grades and score changes
次要结局
- Conjunctival staining test(4 weeks after administration)
- Ocular surface disease index (OSDI)(4 weeks after administration)
- IOP(Intraocular pressure)(4, 12 weeks after administration)
- Tear break up time (TBUT)(4, 12 weeks after administration)
- Corneal staining test(4 weeks after administration)
- Hyperemia score(4, 12 weeks after administration)