跳至主要内容
临床试验/NCT05039684
NCT05039684招募中不适用

Inflammatory Biomarkers in Ocular Surface in Patients With Primary Open Angle Glaucoma and Ocular Hypertension Under Topical Prostaglandin Therapy

Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Inflammatory response in ocular surface secondary to prostaglandin use

研究概览

简要总结

Glaucoma is a chronic optic neuropathy whose main modifiable risk factor is an abnormally elevated intraocular pressure. The aim of glaucoma treatment is to slow the progression of the disease by reducing intraocular pressure.

Prostaglandin derivatives are the most effective topical drugs in reducing intraocular pressure (IOP). Among these, latanoprost was the first agent of this type to be approved for use in patients with glaucoma or ocular hypertension.

These eye drops are available with and without preservatives. There are two commercial brands in our environment, Xalatan®, which contains 0.005% latanoprost and 0.2 mg/ml benzalkonium chloride (BAK) and Monoprost®, which contains the same amount of latanoprost but does not carry a preservative. The prostaglandin analog with a lower concentration of active ingredient available in Spain without preservative is tafluprost 0.0015%, commercially available under the name Saflutan®.

The long-term use of hypotensive eye drops with preservatives generates changes in the ocular surface, such as instability of the tear film, conjunctival inflammation, subconjunctival fibrosis, apoptosis of the conjunctival epithelium and deterioration of the corneal surface, causing symptoms such as stinging, tearing, sensation foreign body, photophobia and blurred vision.

This research will evaluate the changes in the ocular surface and in the expression of inflammatory molecules that occur in the conjunctiva in patients with a diagnosis of glaucoma and ocular hypertension who are under ocular hypotensive treatment with tafluprost, comparing it with the two commercial preparations of latanoprost.

These three groups of patients will have a control group of patients with a diagnosis of ocular hypertension who will not have any topical hypotensive medication.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with primary open angle glaucoma or ocular hypertension as defined in Early Manifest Glaucoma Trial
  • > 18 years old
  • Signed informed consent
  • 3 or more months under monotherapy treatment with tafluprost 0.0015%, latanoprost 0.005% with BAK 0.2mg/ml or latanoprost 0.005%.
  • Untreated patients with ocular hypertension must be treatment naïve for the pathology.
  • No presence or history of previous ocular diseases other than glaucoma or ocular hypertension, started before the use of hypotensive medication.

排除标准

  • Ocular surgery in the previous 6 months.
  • Any ocular surface disease not related to inclusion criteria or related issues active within the last 6 months.
  • Any topical treatment other than the evaluated in this study in the last 3 months.
  • In case of artificial teardrops use, only non conservative ones are allowed, with no more than 4 times per day use, and treatment must be suspended 5 days before inclusion.
  • Use of contact lenses in the las 4 weeks.
  • Any mental or physical disease that may prevent performing the required tests for the study.

结局指标

主要结局

Inflammatory response in ocular surface secondary to prostaglandin use

时间窗: 24 hours

Presence of inflammatory cytokines in ocular surface

Conjunctival cell phenotype and inflammatory infiltration

时间窗: 24 hours

Conjunctival cell phenotype assessment by conjunctival in vivo confocal microscopy

Changes in oxidative stress in the tear film

时间窗: 24 hours

Changes in oxidative stress at conjunctiva secondary to prostaglandin treatment

次要结局

未报告次要终点

研究者

发起方
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Inflammatory Biomarkers in Ocular Surface in Primary... | 临床试验