CTRI/2023/05/052720尚未招募4 期
A Prospective, Multi-centre, Single-arm, Phase IV Study to Assess the Safety and Efficacy of Fixed Dose Combination of Brinzolamide and Timolol Ophthalmic Suspension to Decrease Intraocular Pressure (IOP) in Adult Patients with Open-angle Glaucoma or Ocular Hypertension for whom Monotherapy Provides Insufficient IOP Reduction
Sun Pharma Laboratories Limited (SPLL)22 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2023年5月25日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 155
- 试验地点
- 22
- 主要终点
- Proportion of patients with treatment-emergent adverse events (TEAEs)
研究概览
简要总结
This is a Phase 4, singlearm, multicenter, open label study. The study will be conducted atapproximately 10-15 number of centers in India, having qualified Investigators.The study will be initiated only after the receipt of regulatory and ethicscommittee (EC) approval. After obtaining the informed consent, patientswill be screened by undergoing various assessments as mentioned in Schedule ofAssessment. After confirming the eligibility, test product Brinzolamide andTimolol Ophthalmic Suspension (1% w/v + 0.5% w/v) will be instilled into theaffected eye twice daily. After 12 weeks of treatment period, the end of study visitwill be conducted. During the study, assessments will be performed as mentionedin Schedule of Assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of either gender aged ≥ 18 years who are willing to provide written informed consent 2.Patients diagnosed with Primary Open–angle glaucoma or Ocular hypertension 3.Patients who are on mono-therapy of either carbonic anhydrase inhibitors (CAIs) or Beta-blockers or any other IOP-lowering therapy and not adequately controlled 4.Women of childbearing potential must have a negative urine pregnancy test before study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till at least two weeks after the last dose of the study medication 5.Male patients must have had a successful vasectomy or they and their female partners must meet the criteria above.
排除标准
- •1.Patients with a history of allergic hypersensitivity to oral or topical Carbonic Anhydrase Inhibitors, Beta -blockers, sulfonamide drugs, or any components of these medications 2.Patients with acute or chronic conjunctivitis 3.Patients with reactive airway disease including bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease 4.Patients with known/history of sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block not controlled with pace-maker, overt cardiac failure, and cardiogenic shock 5.Patients with uncontrolled hypertension, dry eye syndrome, diabetic retinopathy, hyperchloraemic acidosis and uncontrolled diabetes 6.Patients with severe allergic rhinitis 7.Patients using intraocular corticosteroid implant 8.Patients using contact lenses within 1 week prior to enrolment 9.Patients using the following medications within two weeks prior to baseline of: 1) topical ophthalmic corticosteroid; 2) topical corticosteroid; 3) systemic corticosteroid, or 4) high dose salicylate therapy 10.Patients using intravitreal or subtenon injection of ophthalmic corticosteroid within 6 months prior to enrolment 11.Patients who are anticipated the need to initiate or modify medication that is known to affect IOP during the study period 12.Patients with severe renal impairment 13.Patients undergone intraocular surgery or laser surgery within the past 3 months 14.Patients currently using any systemic corticosteroid, or is having had therapy with any investigational agent within past 30 days 15.Patients with history of hematologic disorders other than mild anemia 16.Patients with history of non-compliance to medical regimens or those patients unwilling to comply with the study protocol 17.Patients with history of or currently having any of the severe/serious ocular condition or clinically significant medical conditions, such as cardiovascular, respiratory, renal, hepatic, endocrine, or gastrointestinal disease 18.Patients with history of or known case of HIV-AIDS, hepatitis B (Hep B), and hepatitis C (Hep C) 19.Participation in other studies involving investigational drugs or surgeries within the last 30 days or investigational biologics within the last 6 months prior to screening 20.Pregnant or lactating women and women of childbearing potential who are not using contraceptives 21.Investigator, study personnel, Sponsor representatives and their first degree relatives.
结局指标
主要结局
Proportion of patients with treatment-emergent adverse events (TEAEs)
时间窗: Throughout the study period
次要结局
- Change from baseline in 2-hour post-dose IOP(Day 28, 56, and 84)
- Change from baseline in 0-hour pre-dose IOP(Day 28, 56, and 84)
研究者
研究点 (22)
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