A 3-month, Observational Study Investigating With Electronic Monitoring the Level of Adherence and Treatment Satisfaction With Latanoprost/Timolol Fixed Combination Versus Unfixed Therapy in Open-angle Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Rate of adherence
研究概览
简要总结
A 6-month, parallel, non-interventional trial investigating the level of adherence and the impact of dosing in open-angle glaucoma patients who receive either unfixed therapy with latanoprost once in the evening and timolol twice daily, or latanoprost/timolol fixed combination therapy once in the evening. All patients participating in this observational study will be monitored for their adherence with the use of Medication Event Monitoring System (MEMS). At the end of treatment periods treatment satisfaction will be assessed with selected questions from the Treatment Satisfaction Survey-Intraocular Pressure survey. This study will monitor objectively, for the first time, adherence and intraocular pressure control with fixed versus unfixed therapy. Finally it will help us to elucidate the impact of dosing (once-a-day versus three-times-daily) on the level of adherence in glaucoma.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is between 21-80 years old
- •Patient has ocular hypertension or open-angle glaucoma Patient receives therapy and is well controlled on fixed or unfixed latanoprost and timolol therapy
- •Untreated IOP >19 mm Hg <33 mm Hg at baseline (10:00 hour)
- •Open normal appearing angles
- •Patient had at least a 20% reduction vs untreated baseline on current therapy
- •Patient has early or moderate glaucoma (< 14 decibel; 0.8 or better cupping)
- •Distance best corrected Snellen visual acuity greater than 1/10
排除标准
- •Contraindication to timolol or prostaglandin therapy
- •History of lack of response to any medication (< 10%)
- •Patient does not understand the instructions and will not comply to medications
- •Patient can not attend follow up
- •Patient is a female of childbearing potential, or lactating mother
- •History of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses
- •Sign of ocular infection
- •A corneal abnormality that may affect IOP measurements
结局指标
主要结局
Rate of adherence
时间窗: 6 months
Rate of asherence with fixed vs unfixed glaucoma therapy
次要结局
- Ocular surface evaluation(6 months)
- Treatment satisfaction(6 months)
研究者
AGP Konstas
Professor in Ophthalmology
Aristotle University Of Thessaloniki