Multicentric Study to Evaluate the Efficacy and Tolerability of an Innovative Formulation of Benzalkonium Chloride-free Latanoprost in Patients With Primary Open-Angle Glaucoma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Intraocular pressure
研究概览
简要总结
This study evaluates the efficacy and tolerability of a new formulation of latanoprost without Benzalkonium Chloride (BAK-free). Patients with open-angle glaucoma who were using BAK-containing latanoprost ophthalmic solution for ≥6 months, switched to BAK-free latanoprost ophthalmic emulsion.
详细描述
Latanoprost is a prostaglandin F2alfa analogue that increases the uveoscleral outflow of aqueous humor, resulting in a intraocular pressure (IOP) reduction. Benzalkonium chloride (BAK) is usually employed in formulations of prostaglandin analogues due to its dual action of preservative and adjuvant in the formulation. However, this preservative has known toxic effects on the ocular surface, causing ocular dryness and discomfort on long-term use. Benzalkonium Chloride-free (BAK-free)Latanoprost is a new formulation approved for the use in patients with primary open angle glaucoma /ocular hypertension. In this study, patients that were using BAK-containing latanoprost for ≥6 months, switched to a new formulation of BAK-free latanoprost ophthalmic emulsion to evaluate its hypotensive action and quantify the changes in ocular surface parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Men and women aged ≥ 18 years
- •Diagnosed with primary open-angle glaucoma or pseudoexfoliative glaucoma.
- •Receiving containing-BAK latanoprost as monotherapy for at least 6 months
- •Pachymetry between 520 and 580 microns
- •Informed consent given
排除标准
- •History of allergic hypersensitivity or poor tolerance to latanoprost or any components of the formula
- •Angle closure glaucoma or secondary glaucoma
- •History of recent previous glaucoma surgery or trabeculoplasty (less than 1 year of surgery)
- •History of cataract surgery during the last 6 months
- •History of uveitis or intraocular inflammation
- •Corneal alteration
- •Pregnant patients, who wish to conceive or who are in the nursing period.
研究组 & 干预措施
BAK-free latanoprost ophthalmic emulsion
Patients with primary open-angle glaucoma who were using BAK-containing latanoprost ophthalmic solution for ≥ 6 months (baseline), switched to a new formulation of latanoprost ophthalmic product
干预措施: Latanoprost Ophthalmic Product (Drug)
结局指标
主要结局
Intraocular pressure
时间窗: After 12 weeks of treatment with BAK-free latanoprost
Intraocular pressure (IOP) is the fluid pressure inside the eye. Tonometry is the method eye care professionals use to determine it. IOP is an important aspect in the evaluation of patients at risk from glaucoma. Most tonometers measure pressure in millimeters of mercury (mmHg).
次要结局
- Ocular Surface Disease Index (OSDI)(After 12 weeks of treatment with BAK-free latanoprost)
- Conjunctival hyperemia(After 12 weeks of treatment with BAK-free latanoprost)
- Schirmer I test(After 12 weeks of treatment with BAK-free latanoprost)
- Break up time (BUT)(After 12 weeks of treatment with BAK-free latanoprost)
- Corneal epithelial fluorescein staining(After 12 weeks of treatment with BAK-free latanoprost)
- Tear meniscus height(After 12 weeks of treatment with BAK-free latanoprost)