Ocular Surface Conditions in Asian Glaucoma Patients With Existing Corneal Disorders Switching From Preserved Prostaglandin Analogues Monotherapy to Preservative-free Tafluprost
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Changes in the fluorescein staining score (NEI) at Visit 2
研究概览
简要总结
This study is conducted to document the effect of switching from preserved prostaglandin analogues monotherapy to preservative free tafluprost 0.0015%. The endpoints analyzed are side effect improvement in these patients.
详细描述
Importance: Glaucoma medications are often preserved with agents such as benzalkonium chloride, which commonly lead to ocular surface diseases.
Background: To investigate the effect of switching to a preservative-free prostaglandin analogue, tafluprost 0.0015% on treatment tolerability and ocular surface diseases.
Design: This was a prospective, open label, non-randomised, observational study performed in a single hospital.
Participants: Patients of Asian descent who have primary open angle glaucoma and ocular hypertension (n = 28), who received preserved prostaglandin monotherapy for longer than 3 months, and has a National Eye Institute ocular surface staining scale score higher than 1.
Methods: Patients were switched from preserved prostaglandin monotherapy to preservative-free tafluprost 0.0015%. Patients were analysed at baseline (Visit 0), 1 month (Visit 1) and 3 months (Visit 2).
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 21 years or older and those who can provide informed consent.
- •Patients who have corneal disorders due to the prostaglandin usage. (At least one eye must have a score above 1 on the NEI scale)
- •Intraocular pressure (IOP) ≤ 21 mm Hg in the study eye at the screening examination (under treatment)
- •If only one eye is eligible, it is to be evaluated. If both eyes are eligible, then the eye with a higher NEI score will be selected for evaluation.
- •Pretreatment must be monotherapy with any of the following preserved ophthalmic solutions; latanoprost, travoprost, bimatoprost or tafluprost and its period must be longer than 3 months.
- •Outpatients who can visit the clinic on the designated day as instructed by the physician.
- •A best-corrected ETDRS visual acuity score of +0.6 logMAR (Snellen equivalent of 20 ⁄ 80) or better in each eye.
排除标准
- •Those with severe visual field disorder (Mean deviation of 15 dB or worse)
- •Those with a history of ocular surgeries (such as corneal refractive surgery, intraocular surgery including ocular laser treatment which may affect the patient's ocular surface condition) within 6 months prior to the study initiation.
- •Those with severe dry eye (those in need of drug to treat dry eye), ocular allergy, ocular infection or ocular inflammation
- •Those who need to use systemic or ophthalmic steroids (excluding topical skin steroidal ointment) and anti-glaucoma agents other than latanoprost, travoprost, bimatoprost or preservative free tafluprost ophthalmic solution
- •Female patients who are pregnant, nursing or lactating
- •Those with a history of drug allergy (hypersensitivity) to the drugs to be used during the study period (anesthetic ophthalmic solution, fluorescein, etc.) or similar drugs to the investigational product
- •Those who need to wear contact lenses during the study period
- •Any corneal abnormality or other condition preventing reliable applanation tonometry
- •Anterior chamber angle less than grade 2 according to Schaffer classification as measured by Gonioscopy
- •Any uncontrolled systemic disease (e.g. hypertension, diabetes)
研究组 & 干预措施
Treatment group
The intervention will be preservative free tafluprost 0.0015% topical ophthalmic solution given once daily for the study duration.
干预措施: preservative free tafluprost 0.0015% (Drug)
结局指标
主要结局
Changes in the fluorescein staining score (NEI) at Visit 2
时间窗: 3 months
The fluorescein stained area of the cornea will be measured according to the National Eye Institute/Industry (NEI/I) method. NEI grading scale consists of a grid that divides the corneal area into five sections, each of which is assigned a score between zero and 3 depending of the amount and distribution of Corneal Fluorescein Stain (CFS); the total CFS score ranges from 0/15 (absence of corneal epitheliopathy) to 15/15 (severe epitheliopathy)
次要结局
未报告次要终点
研究者
Thanendthire Sangapillai
Principal Investigator, Ophthalmology Senior Registrar
Tun Hussein Onn National Eye Hospital