A Multicenter Study of the Pigmentation in the Trabecular Meshwork After Two Years of Treatment With TRAVATAN 0.004% Ophthalmic Solution
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 88
- 主要终点
- Melanin Granule Count
研究概览
简要总结
The purpose of this study was to assess the pigmentation in the trabecular meshwork of patients who had been treated for at least 2 years with TRAVATAN compared with patients without exposure (or less than 1 month) to a prostaglandin analogue (PGA).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of open-angle glaucoma without pseudoexfoliation or pigment dispersion component;
- •Either two or more years of dosing with Travatan, or no prior exposure (less than 1 month) to a topical ocular prostaglandin;
- •Requires a trabeculectomy;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Pseudoexfoliation or pigment dispersion;
- •History of chronic or recurrent severe inflammatory eye disease;
- •History of or current ocular infection or ocular inflammation within the past 3 months in either eye;
- •Greater than one month but less than two years of exposure to TRAVATAN;
- •Pregnant, breast-feeding, not using highly effective birth control;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
TRAVATAN
As prescribed by physician for the treatment of open-angle glaucoma and dosed for at least two years
干预措施: Trabecular Meshwork Tissue Collection (Procedure)
TRAVATAN
As prescribed by physician for the treatment of open-angle glaucoma and dosed for at least two years
干预措施: Travoprost 0.004% ophthalmic solution (Drug)
Treatment Naive
No prior exposure (or less than 1 month) to any topical, ocular prostaglandin analogue
干预措施: Trabecular Meshwork Tissue Collection (Procedure)
结局指标
主要结局
Melanin Granule Count
时间窗: Day 1
A trabecular meshwork tissue sample was collected by the investigator. The number of pigment granules was counted for three separate microscopic fields of view. Mean melanin granule count was calculated.
次要结局
未报告次要终点