The Secondary Beneficial Effects of Prostaglandin Analog Treatment in Thyroid Eye Disease Patients.
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change from baseline in appearance of facial periorbital region at 6 months.
研究概览
简要总结
The purpose of this study is to evaluate the potential secondary beneficial effect of prostaglandin analogues (PA) treatment in thyroid eye disease (TED) patients. This study aims to determine if PA would change the course of the orbitopathy in TED patients by altering the progression of the common features of TED, including fatty hypertrophy, proptosis, eyelid retraction and optic nerve compression. The eyes with thyroid eye disease and elevated intraocular pressure will be randomised to the PA treatment and the other eye will serve as a control eye and will be treated with Timolol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •mild or moderate to severe thyroid eye disease in one or both eyes
- •age > 18 years
- •informed consent
- •intraocular pressure > 21 mmHg or glaucoma suspect or glaucoma diagnosed in one or both eyes
- •not on current prostaglandin analog intraocular pressure lowering therapy
排除标准
- •sight threatening thyroid eye disease
- •children < 18 years old
- •patients that are not compliant with treatment or follow-up
- •patients already on prostaglandin analog treatment
- •patients that undergo cosmetic periocular procedures during the study will be excluded from further follow up
- •patients that cannot tolerate prostaglandin analog treatment.
- •patients with bilateral thyroid eye disease and elevated intraocular pressures that cannot tolerate treatment with timolol or an alternative intraocular pressure lowering medication such as trusopt, combigan, cosopt.
研究组 & 干预措施
Prostaglandin Analog vs Timolol
In this group, with thyroid eye disease and increased intraocular pressure in both eyes, prostaglandin analog eyedrop (bimatoprost 0.01%, travoprost z 0.004%, tafluprost 0.0015% or latanoprost 0.005%) will be administered once a day, topically, into one - randomised eye. Timolol 0.5% eye drop will be administered topically in second, control eye, two times a day.
干预措施: Prostaglandin Analog (Drug)
Prostaglandin Analog vs Timolol
In this group, with thyroid eye disease and increased intraocular pressure in both eyes, prostaglandin analog eyedrop (bimatoprost 0.01%, travoprost z 0.004%, tafluprost 0.0015% or latanoprost 0.005%) will be administered once a day, topically, into one - randomised eye. Timolol 0.5% eye drop will be administered topically in second, control eye, two times a day.
干预措施: Timolol (Drug)
Prostaglandin Analog
In this group, with thyroid eye disease and increased intraocular pressure in only one eye Prostaglandin Analog eyedrop (bimatoprost 0.01%, travoprost z 0.004%, tafluprost 0.0015% or latanoprost 0.005%) will be administered once a day, topically, into one, affected eye.
干预措施: Prostaglandin Analog (Drug)
结局指标
主要结局
Change from baseline in appearance of facial periorbital region at 6 months.
时间窗: Baseline and 6 months
次要结局
- Change from baseline in intraocular pressure at 3, 6, 9 and 12 months.(Baseline and 3, 6, 9 and 12 months)
- Change from baseline in Hertel exophthalmometry at 3, 6, 9 and 12 months.(Baseline and 3, 6, 9 and 12 months)
- Change from baseline in appearance of facial periorbital region at 3, 6, 9 and 12 months.(Baseline and 3, 6, 9 and 12 months)
研究者
Andrea L Kossler
M.D.
Stanford University