Comparison of Efficacy and Ocular Surface Disease Assessment Between BRIDIN-T Eye Drops 0.15% and ALPHAGAN-P Eye Drops 0.15% in Glaucoma or Ocular Hypertensive Patients : Phase 4, Parallel Group Design, Investigator-blind, Active-control, Randomized, Multi-center Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Corneal staining test
研究概览
简要总结
Comparison of Efficacy and Ocular Surface Disease Assessment between BRIDIN-T Eye drops 0.15% and ALPHAGAN-P Eye drops 0.15% in Glaucoma or Ocular Hypertensive Patients : Phase 4, Parallel Group Design, Investigator-blind, Active-control, Randomized, Multi-center Trial
详细描述
Following 12 weeks of administration of BRIDIN-T Eye drops 0.15%(non preservative) or ALPHAGAN-P Eye drops 0.15%(preservatives) for patients with glaucoma or Ocular Hypertensive Patients. The use of BRIDIN-T Eye drops(non preservative) is less harmful to external ophthalmicus diseases and increase of medication compliance for ophthalmic drugs than the ALPHAGAN-P Eye drops 0.15%(preservatives)
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
- Double (Participant, 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
- •Adult(Male or Female) over 19 years who were diagnosed with glaucoma or ocular hypertension
- •In the case of a person receiving a glaucoma treatment drug, a person who has completed the appropriate in wash-out period for the existing glaucoma drug before the investigational product is administered.
- •Intraocular pressure (IOP) >/= 15mmHg and < 40mmHg in each eye using Goldmann applanation tonometry at visit 2
- •Written consent voluntarily to participate in this clinical trial
排除标准
- •Patients with primary closed-angle glaucoma, congenital glaucoma and secondary glaucoma caused by steroid drugs, etc.
- •BCVA (best-corrected visual acuity) Snellen equivalent of Snellen 20/80(logMar 0.25) or less.
- •Those who have ongoing medical history as intraocular inflamation.
- •Central corneal thickness is not between 470um and 591um.
- •Patients who have received lacrimal passive occlusion within the last three months or who have surgery plans during the clinical trial period.
- •Pregnant or nursing women.
- •Patients judged coexisting disease that could interfere with the completion of the treatment or safety of this clinical trial. Patients that other researchers are determined inadequately
研究组 & 干预措施
BRIDIN-T Eye drops 0.15%(Non preservative)
Brimonidine Tartrate 1.5mg : 1 drop 3 times a day for 12 weeks to target eyes
干预措施: Brimonidine Tartrate 1.5mg (Drug)
ALPHAGAN-P Eye drops 0.15%(Preservatives)
Brimonidine Tartrate 1.5mg : 1 drop 3 times a day for 12 weeks to target eyes
干预措施: Brimonidine Tartrate 1.5mg (Drug)
结局指标
主要结局
Corneal staining test
时间窗: Administered 12 weeks after
The degree of staining of the cornea after blue fluorescein staining under the slit lamp illumination of a cobalt blue light source using a yellow filter was evaluated on a 6 point scale according to the oxford grading system
Ocular surface disease index (OSDI)
时间窗: Administered 12 weeks after
The ocular surface disease index was assessed for ocular surface disease, including visual function (five items), eye symptoms (four items), and environmental factors (three items) , 0 point for no symptoms, 1 point for occasional symptoms, 2 points for symptoms of half a day, 3 points for most symptoms, and 4 points for symptoms during the whole day.
Conjunctival staining test
时间窗: Administered 12 weeks after
After lysamine green staining under slit lamps, the conjunctiva was divided into the nasal side and the lateral side, and the degree of nasal conjunctiva and bilateral conjunctival staining was evaluated on a 6-point scale according to the oxford grading system
Questionnaire (Evaluation of Satisfaction with Medication, Ocular tolerance)
时间窗: Administered 12 weeks after
The evaluation of satisfaction with medication is conducted with a questionnaire evaluation on the convenience of use, storage of investigational product, and the ocular tolerance. Evaluation is conducted on 8 symptoms of tingling/hot, sticky, itchy, blurred vision, foreign body sensation, dryness, glare, and pain. Assess the severity of symptoms (0-3 points) and duration of symptoms (immediate, continuous)
次要结局
- Ocular surface disease index (OSDI)(Administered 4 weeks after)
- Conjunctival staining test(Administered 4 weeks after)
- Corneal staining test(Administered 4 weeks after)
- IOP(Intraocular pressure)(Administered 4, 12 weeks after)
- Tear break up time (TBUT)(Administered 4, 12 weeks after)
- Slit Lamp Biomicroscopy Findings - Limbal Redness(Administered 4, 12 weeks after)
研究者
Seungsoo Rho
Associate Professor., M.D., Ph.D.
CHA University