Pilot Study Comparison of Combigan Two Times Daily (BID) vs Simbrinza Three Times Daily (TID) in Subjects Currently Treated With Latanoprost For Open-Angle Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Intraocular Pressure
研究概览
简要总结
To compare Combigan Two Times Daily (BID) vs Simbrinza Three Times Daily (TID) in subjects currently being treated with Latanoprost for Open-Angle Glaucoma or Ocular Hypertension. Both of these drugs are currently FDA approved as combination therapy for patients with Open-Angle Glaucoma or Ocular Hypertension. The purpose of this clinical trial would be to assess which treatment, if either, is superior in lowering intraocular pressure (IOP). A secondary objective is to assess the tolerability of each drug.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Open-angle glaucoma or ocular Hypertension
- •Currently treated with Latanoprost for min of 6 weeks
- •Male or Female 18 yrs and older
- •Best Corrected Visual Acuity 20/100 or better in both eyes
- •Pachymetry >470 and < 640
- •Women of childbearing potential must have a negative urine pregnancy test at the screening/baseline visit
- •Patient willing and capable of providing informed consent
排除标准
- •C/D > 0.8
- •Visual field loss, which in the opinion of the investigator is functionally significant
- •Current use of ocular steroids
- •Concurrent significant active ocular disease History (within 3 months prior to Screening) of ocular laser, intraocular, filtering or refractive surgery or planned ocular surgery of any kind during study participation
- •Change within prior 30 days or anticipated change in any systemic medication that is known to affect IOP
- •Uncontrolled systemic disease
- •Significant ocular hyperemia at baseline
- •Prior glaucoma procedure within 3 months
- •Females who are pregnant, nursing, or planning a pregnancy or who are of childbearing potential and not using a reliable method of contraception
- •Known allergy or sensitivity to any study medication
- •Asthma or any other known medical condition that the investigator feels would put patient at increased risk from any of the study medications
- •Current enrollment in an investigational drug or device study or participation in such a study within 30 days prior to Screening
研究组 & 干预措施
Combigan Two Times Daily (BID)
Combigan 0.2%/0.5% one drop Two Times Daily (BID)
干预措施: Combigan Two Times Daily (BID) (Drug)
Simbrinza Three Times Daily (TID)
Simbrinza 1/0.2% one drop Three Times Daily (TID)
干预措施: Simbrinza Three Times Daily (TID) (Drug)
结局指标
主要结局
Intraocular Pressure
时间窗: Day 0 (08:00, 10:00 16:00), Day 30 (08:00, 10:00, 16:00), Day 90 (08:00, 10:00,16:00)
The Intraocular Pressure will be assessed on study subjects. IOP (Intraocular Pressure) will be measured using a Goldmann applanation tonometer. Both eyes will be tested, with the right eye preceding the left eye. The operator will initially set the dial at 10 mmHg, then look through the slit lamp and adjust the dial to take the reading, and then record the results. The procedure will be repeated on the same eye twice consecutively. If the measurements are within 2mmHg or less of each other, the mean of the 2 reading will be reported as the IOP at that time point. If the 2 reading are more than 2mmHg apart from each other, a third (consecutive) reading will be taken and the median (middle) IOP will be reported as the IOP at that time point. Preferable, the same operator will measure IOP and the same tonometer will be used at each visit.
次要结局
- Ocular Symptom and Tolerability Questionaire(Baseline (Day 0), Visit 2 (Day 7), Visit 3 (Day 30), Visit 4 (Day 90))
研究者
Michael Tepedino MD
Director of Clinical Research
Cornerstone Health Care, PA