Phase 2 Study of Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Latanoprost Therapy
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Intraocular Pressure
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness in lowering intraocular pressure (IOP) utilizing an experimental lotion containing 0.005% Latanoprost that is applied to the outside of one eyelid.
详细描述
Glaucoma is the leading cause of irreversible blindness worldwide, with primary open-angle glaucoma the most common form of glaucoma. Vision loss is caused by damage to the optic nerve. The modern goals of glaucoma management are to avoid glaucomatous damage, nerve damage, preserve visual field and total quality of life for patients with minimal side effects.
Although intraocular pressure is only one of the major risk factors for glaucoma, lowering it via various pharmaceuticals and/or surgical techniques is currently the mainstay of glaucoma treatment. Intraocular pressure can be lowered with medication, usually eye drops. There are several different classes of medications to treat glaucoma with several different medications in each class. In order to prevent blindness from glaucoma, it is critical that patients take their glaucoma eye drops accurately and faithfully for the rest of their lives. Poor compliance with medications and follow-up visits is a major reason for vision loss in glaucoma patients. In addition, coordination involved in placing an eye drop in the eye is considerably more difficult and unpleasant to patients than many other therapies. Thus, localized transdermal eyelid lotion would create a leap in safety of drug delivery while at the same time rendering ocular drugs easy and non traumatic to use.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with a clinical diagnosis of stable Chronic Open Angle Glaucoma and stable Vital signs who are controlled on a stable dose of a single IOP lowering agent and who have demonstrated stable target intraocular pressure for a minimum of 3 months.
- •Male or Female patients aged at least 18 years of age.
- •Females of childbearing potential must use a reliable form of contraception throughout the study period such as celibacy, birth control pills, or condoms.
- •A negative urine pregnancy test result at Screening and Baseline (Day 1) for women of childbearing potential.
- •Best-Corrected Visual Acuity of 20/800 or better in both eyes
- •Written informed consent.
- •Ability to follow instructions and likely to complete all study visits based upon patient factors such as cognition, reliability, motivation, and ability to obtain reliable transportation to study site.
排除标准
- •Uncontrolled glaucoma
- •Glaucoma requiring more than a single agent for IOP control
- •Patients with a corneal thickness greater then 620 micrometers
- •Female patients who are pregnant, nursing, or planning a pregnancy during the study
- •Patient who has any situation or condition, which in the investigator's opinion, may put the patient at a significant risk, may confound the study result or may interfere significantly with the participation in the study
- •Active intraocular inflammation
- •Cystoid Macular Edema
结局指标
主要结局
Intraocular Pressure
时间窗: Day thirty, once.
Change in Intraocular Pressure from baseline.
次要结局
未报告次要终点
研究者
Padma Nanduri, MD, FACS
Principal Investigator
Nanduri, Padma, M.D., FACS