The Effects of Latanoprost, Bimatoprost and Travoprost on Periocular Skin Pigmentation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 2
- 主要终点
- The Extent of Latanoprost, Bimatoprost and Travoprost Induced Periocular Skin Hyperpigmentation Over a One Year Time Course in Newly Diagnosed Primary Open Angle and Ocular Hypertension Patients.
研究概览
简要总结
The purpose of this study is to study changes in skin color that may be caused by using one of the three eye medicines: Xalatan, Travatan or Lumigan.
详细描述
One uncommon side effect of prostaglandin eye drops is a change in color of the skin around the eyes, which is reversible. There are three different brands of the medicine which are equally effective in lowering eye pressure but their likelihood of changing skin color is unknown. Qualifying patients will be randomly assigned to use one of the three eye drops. We will take skin color measurements from several locations on the face over one year to measure pigmentation changes.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients recently diagnosed with primary open angle glaucoma or ocular hypertension
- •Caucasian and African American ethnicities
- •Male and Female
- •Age 30 and above
排除标准
- •A history of ocular medication use within the last 12 months
- •Inflammatory/ allergic skin diseases or dermatitis
- •presence of periocular hyperpigmented skin lesions
- •Systemic pigmentation disorders
- •Use of systemic drugs that can affect skin pigmentation
- •Visitation of tanning salons, or use of self tanning products
- •Pregnancy or patients planning to become pregnant in the near future
研究组 & 干预措施
Lumigan
Patients assigned to Lumigan/bimatoprost one drop before bedtime (qhs) to affected eye(s)
干预措施: bimatoprost (Drug)
Xalatan
Patients assigned to Xalatan/latanoprost one drop before bedtime (qhs) to affected eye(s)
干预措施: latanoprost (Drug)
Travatan
Patients assigned to Travatan/travoprost one drop before bedtime (qhs) to affected eye(s)
干预措施: travoprost (Drug)
结局指标
主要结局
The Extent of Latanoprost, Bimatoprost and Travoprost Induced Periocular Skin Hyperpigmentation Over a One Year Time Course in Newly Diagnosed Primary Open Angle and Ocular Hypertension Patients.
时间窗: one year
Periocular skin color was measured with the Minolta Chroma Meter CR-400 and the L\*a\*b\* system, also known as Commission Internationale de l'Eclairage. This is a well-accepted unit of measurement in which L\* corresponds to brightness and a\* and b\* correspond to chromaticity. Measurements were taken at baseline and 1 year. Data from each time point and each location (upper and lower eyelids or cheeks/face) were averaged, and subtracted from the baseline value for that location. Six predetermined areas on and around the upper and lower eyelid and 2 areas of the face/cheek were measured.Upper and lower eyelid values were averaged and reported as single value for each location ie;-upper eyelids, lower eyelid and cheek/face. A decrease in luminance indicates increased pigmentation at the site of measurement.
次要结局
未报告次要终点