CTRI/2025/11/097648招募中4 期
A Multicentric, Open-label, Prospective Non-comparative Active Post Marketing Surveillance Study to evaluate the Safety Tolerability and Efficacy of Fixed Dose Combination of Brinzolamide 10 mg, Brimonidine Tartrate 2 mg and Timolol 5 mg Ophthalmic Suspension to reduce elevated Intraocular Pressure (IOP) in adult participants with Open Angle Glaucoma or Ocular Hypertension for whom monotherapy or dual therapy provides insufficient IOP reduction
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 230
- 试验地点
- 10
- 主要终点
- 1. The assessment of the safety of participants [Based on the incidence of treatment-emergent adverse event (TEAE)].
研究概览
简要总结
Subjects will be screened on day -3 and if qualify as per the inclusion and exclusion criteria, then will consider for enrollment. the subjects will be provided with study drug and drug dosing card at enrollment visit (Day 1), which need to be brought along with in each subsequent visit till the last visit. Follow-up visits after enrollment into the study will be done on Day 14±2, Day 42±2 and the final visit at Day 84±2 of treatment to assess safety, tolerability and efficacy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult male and female participants more 18 to less then 75 years of age.
- •Diagnosed with unilateral or bilateral open angle glaucoma (including pseudo exfoliation or pigment dispersion) or ocular hypertension.
- •Participants who are already on monotherapy or dual drug therapy on any of the following anti-glaucoma drugs, Timolol (0.5 percent), Brimonidine (0.1 or 0.2 percent), Brinzolamide (1 percent) or Dorzolamide (2 percent) eye drops with IOP of 22-32 mmHg in at least one eye.
- •Best Corrected Visual Acuity (BCVA) of 6 by 24 or better in study eye(s).
- •Participants who are willing to give informed consent for participation in the study and willing to adhere to all protocol procedures.
排除标准
- •Participants with a known history of hypersensitivity to the study medications or any of the ingredients of the formulation.
- •Clinically significant or progressive retinal disease (i.e. retinal degeneration, diabetic retinopathy, retinal detachment or retinal tears) or optic nerve disease.
- •Ocular laser surgery within 3 months prior to entry.
- •Any intraocular surgery (e.g, cataract surgery) within 6 months prior to entry.
- •Corneal abnormalities that could preclude accurate IOP readings with tonometry.
结局指标
主要结局
1. The assessment of the safety of participants [Based on the incidence of treatment-emergent adverse event (TEAE)].
时间窗: 12 weeks
2. The assessment of the tolerability of the study drug will be based on the incidence of AEs and SAEs.
时间窗: 12 weeks
次要结局
- 1. Change from baseline in the mean IOP at Visit 3/Week 2/Day 14±2, Visit 4/Week 6/Day 42±2 and Visit 5/Week 12/Day 84±2.(12 weeks)
研究者
Dr Mohita Sharma
Tirupati Eye Centre and Research Institute
研究点 (10)
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