NCT02471105Unknown4 期
IOP and Tolerability Study of Preserved Bimatoprost 0.1% or Tafluprost Unit Dose Preservative Free 15microgram/ml, in Patients With OHT or Glaucoma Suitable for Prostaglandin Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 67
- 试验地点
- 7
- 主要终点
- the difference in mean IOP values between the 2 groups
研究概览
简要总结
This cross-over study will investigate the efficacy and safety of BIMMD and TUDPF in a clinical setting.
详细描述
- A prospective, randomized, investigator-masked, crossover comparison;
- Ocular hypertension or glaucoma (XFG or POAG) patients and who consent to participate will be enrolled in this study
- Patients will be scheduled for a screening visit IOP assessment (IOP measurements at 08:30, 12:30 and 16:30 (±1 hour).
- Patients who are on therapy at the screening visit and who consent to participate will undergo a washout period for 4 weeks (depending on therapy) before the baseline visit;
- Patient can under the washout period be given brinzolamide (Azopt) if needed, Azopt should then be discontinued 5 days before baseline visit;
- After the screening visit (and after wash-outperiod for treated patients) patients will be scheduled to undergo a baseline visit IOP assessment (IOP measurements at 08:30, 12:30 and 16:30 (± 1 hour with a minimum of 3 hours between readings) and will then be randomized for Period 1 to receive either BIMMD drops once in the evening (20:30) or TUDPF drops once in the evening (20:30) for 3 month
- After 3 month, patients will be switched for Period 2, to the opposite treatment (e.g. switched to either BIMMD or TUDPF) to be dosed in the evening;
- After another 3 months they will undergo the final evaluation of IOP levels and of tolerability;
- Intermediate safety visits may be scheduled at the discretion of the investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A patient suffering from ocular hypertension, XFG or POAG and needs treatment in both eyes
- •Patient is at least 18 years
- •Patient is able and willing to participate in the study for the whole duration of the follow up and is willing to sign the consent form.
排除标准
- •Unwilling to sign informed consent;
- •Younger than 18 years old;
- •Ocular condition that are of safety concern and that can interfere with the study results;
- •Visual field defects with an MD value above -15dB on either eye on Humphrey (or the equivalent in Octopus) and/or threatening fixation
- •Contact lens wearer;
- •Closed/barely open anterior chamber angles or history of acute angle closure on either eye as assessed by gonioscopy;
- •Ocular surgery (other than glaucoma surgery) or argon laser trabeculoplasty within the past three months on either eye;
- •Glaucoma surgery within the past 6 months on either eye;
- •Ocular inflammation/infection occurring within three months prior to pre-trial visit on either eye;
- •Concomitant topical ocular medication that can interfere with study medication on either eye;
- •Known hypersensitivity to any component of the trial drug solutions;
- •Other abnormal condition or symptom preventing the patient from entering the trial, according to the Investigator's judgement;
- •Refractive surgery patients at any time;
- •Women who are pregnant, are of childbearing potential and are not using adequate contraception or are nursing;
- •Inability to adhere to treatment/visit plan;
- •Have participated in any other Interventional clinical trial (i.e., requiring informed consent) involving an investigational drug within one month prior to pre-trial visit.
- •History of COPD, asthma or heart failure
研究组 & 干预措施
Lumigan 0.01% + Saflutan 15 µg/ml
Experimental
Bimatoprost 0.01 % Eye drops solution Topical use Once in the evening 3 months
干预措施: Preserved Bimatoprost 0.01% (Drug)
Lumigan 0.01% + Saflutan 15 µg/ml
Experimental
Bimatoprost 0.01 % Eye drops solution Topical use Once in the evening 3 months
干预措施: Tafluprost Unit Dose Preservative Free 15microgram/ml (Drug)
Saflutan 15 µg/ml + Lumigan 0.01%
Experimental
Tafluprost Unit Dose Preservative Free 15microgram/ml Eye drops solution Topical use Once in the evening 3 months
干预措施: Preserved Bimatoprost 0.01% (Drug)
Saflutan 15 µg/ml + Lumigan 0.01%
Experimental
Tafluprost Unit Dose Preservative Free 15microgram/ml Eye drops solution Topical use Once in the evening 3 months
干预措施: Tafluprost Unit Dose Preservative Free 15microgram/ml (Drug)
结局指标
主要结局
the difference in mean IOP values between the 2 groups
时间窗: 6 months
次要结局
- the difference in IOP values between the groups in change from baseline IOP(month 3 and month 6)
- the difference in mean IOP between the 2 groups(month 3)
- the difference in IOP between the 2 groups at each timepoints(month 3 and month 6)
研究者
研究点 (7)
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