The Advantage of Switching From Preserved to Preserved-free Treatments in Glaucoma. A Clinical and Confocal Study.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes in the difference in the fiber density of the subbasal nerves in the central cornea and in each of 4 limbal quadrants
研究概览
简要总结
A 1-year prospective, randomized, investigator-masked trial comparing the confocal and clinical effects of treatment with unpreserved prostaglandins (tafluprost) versus preserved prostaglandins (latanoprost) in newly-diagnosed glaucoma patients.
详细描述
The study protocol comprises 5 visits: baseline, month 3, month 6, month 9, month 12.
At baseline a clinical evaluator will perform a complete ophthalmologic evaluation to confirm diagnosis. The following examinations will be done in the following sequence: anterior segment examination, Shirmer test, Break-up time test. Thereafter, a confocal evaluator will perform confocal microscopy of the central and the peripheral cornea. Finally, contact measurements will be done in the following order: IOP (which will be measured at 3 pm), pachimetry (only at baseline visit) and gonioscony (only at baseline visit). A 15 minutes interval will elapse between two consecutive tests.
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
- 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
- •The patient is suffering from ocular hypertension, POAG, PEX, NTG. Glaucoma definition is based on the European Glaucoma Society Guidelines.
- •The patient is newly-diagnosed
- •No fluorescein staining at baseline and no observable signs of ocular surface disease
- •No treatment with topical BAK-containing products for at least 6 months
- •Treatment of naïve patients
排除标准
- •Unwilling to sign informed consent
- •Not at least 18 years old
- •Ocular condition that are of safety concern and that can interfere with the study results
- •Closed/barely open anterior chamber angles or history of acute angle closure.
- •Ocular surgery or argon laser trabeculoplasty within the last year. Ocular inflammation/infection occurring within three months prior to pre-trial visit.
- •Presence of the following ocular conditions: KCS, moderate-severe blepharitis, Rosacea, Sjogren syndrome, pterygium, contact lens users.
- •Use of concomitant topical ocular medication that can interfere with study medication
- •Hypersensitivity to benzalkonium chloride or to any other component of the trial drug solutions.
- •Any corneal pathology
- •Diabetes at any stage
- •Other abnormal condition or symptom preventing the patient from entering the trial, according to the Investigator's judgement.
- •Refractive surgery patients
- •Women who are pregnant, are of childbearing potential and are not using adequate contraception or are nursing.
- •Inability to adhere to treatment/visit plan.
- •Have participated in any other clinical trial (i.e., requiring informed consent) within one to three month prior to pre-trial visit (depending on ethics committee decisions).
研究组 & 干预措施
Tafluprost
1 drop of tafluprost to eligible eye(s) once daily (at 9 pm)
干预措施: Tafluprost (Drug)
Latanoprost
1 drop of latanoprost to eligible eye(s) once daily (at 9 pm)
干预措施: Latanoprost (Drug)
结局指标
主要结局
Changes in the difference in the fiber density of the subbasal nerves in the central cornea and in each of 4 limbal quadrants
时间窗: Month 3, 6, 9, 12
次要结局
- Changes in sub-basal nerve characteristics (reflectivity, beading, tortuosity)(Months 3, 6, 9 ,12)
- Changes in density of epithelial cells, Langerhans cells, endothelial cells(Month 3, 6, 9 ,12)
- Changes in ocular surface (symptom and sign scales, break-up time, Schirmer test)(Month 3, 6, 9, 12)
研究者
Paolo Fogagnolo
Prof. Luca Rossetti
University of Milan