Safety and Efficacy Study in NTG, POAG, Glaucoma Suspect, Ocular Hypertension Patients With Diagnosed Prostaglandin Associated Peri-orbitopathy Switching From Preserved Prostaglandin Analogues Monotherapy to Omidenepag Isopropyl
试验速览
- 阶段
- 4 期
- 入组人数
- 150
- 试验地点
- 8
- 主要终点
- Improvement rate of DUES(Deepening of Upper Eyelid Sulcus)
研究概览
简要总结
This study is for patients have been using prostaglandin analogue eye drops with a preservative for 3 months or more and have been diagnosed with prostaglandin-associated peri-orbital disease.
the investigators would like to confirm the real world evidence(RWE) of safety and efficacy after changing to Eybelis ophthalmic solution 0.002%.
详细描述
This clinical trial is a single-arm, multicenter, prospective clinical trial, in which participants have consented to participate in the clinical trial are sequentially registered and proceeded.
The participant's participation period is a total of 24 weeks after the 4-week wash-out period, and according to the visit schedule, tests according to medical procedures are conducted at Screening, Baseline, 6, 12, 18, and 24 weeks to collect data on safety and effectiveness.
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
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults between 19 and 79 years of age.
- •Normal Tension Glaucoma, Primary open-angle glaucoma, Glaucoma suspect and Ocular hypertension patients.
- •Patients who have received prostaglandin analogue (PGA) eye drops with preservatives for at least 3 months from the date of consent.
- •Patients diagnosed with prostaglandin associated peri-orbitopathy due to the use of Prostaglandin analogue (PGA) eye drops with preservatives.
- •DUES (Deepening of Upper Eyelid Sulcus)
- •FLEB (Flattening of Lower Eyelid Bag)
- •Upper eyelid ptosis
- •Periorbital hyperpigmentation
- •Ciliary hypertrichosis
- •Those who have agreed in writing to participate in this clinical trial.
排除标准
- •Patients with glaucoma caused by secondary causes such as pseudo-exfoliative glaucoma and pigment dispersion syndrome
- •Patients with intraocular pressure greater than 34 mmHg
- •Patients with severe visual impairment (Mean deviation -20dB or more)
- •History of eye surgery within 6 months from the date of consent (Corneal refractive surgery or intraocular surgery including LASIK and LASEK that affect the condition of the ocular surface)
- •Patients with severe dry eyes (those receiving or in need of drug treatment), those with eye allergies, infections, or inflammatory diseases
- •Those who are using systemic or eye steroids (except for topical skin)
- •Those who are using eye drops for the treatment of glaucoma other than Prostaglandin analogues eye drops with preservatives
- •Pregnant or lactating women
- •Those with hypersensitivity to anesthetic eye drops, fluorescein, or research drugs
- •Those who need to wear contact lenses during the clinical trial period
- •Artificial lens eye (pseudophakia) or aphakic eye (aphakia)
- •Periocular trauma, surgical history, or thyroid orbitopathy affecting the evaluation of prostaglandin associated peri-orbitopathy
- •Other clinical investigators judged to be inappropriate to participate in clinical trials
研究组 & 干预措施
omidenepag isopropyl 0.02mg
Instill 1 drop of Eybelis ophthalmic solution 0.002% once a day into the affected eye.
干预措施: Eybelis ophthalmic solution 0.002% (Drug)
结局指标
主要结局
Improvement rate of DUES(Deepening of Upper Eyelid Sulcus)
时间窗: 24 weeks
Primary efficacy parameter in prostaglandin associated peri-orbitopathy diseases at 24 weeks compared to baseline. -DUES (Deepening of Upper Eyelid Sulcus) Evaluate based on the following criteria. Grading is evaluated from 0 to 4 points. grade 0 = none; grade 1 = trace, barely visible; grade 2 = mild; grade 3 = moderate, easily detected; grade 4 = severe;
次要结局
- Improvement rate of FLEB (Flattening of Lower Eyelid Bag)(24 weeks)
- Improvement rate of Upper eyelid ptosis in prostaglandin-associated peri-orbitopathy(24 weeks)
- Improvement rate of Periorbital hyperpigmentation in prostaglandin-associated peri-orbitopathy(24 weeks)
- Improvement rate of Ciliary hypertrichosis in prostaglandin-associated peri-orbitopathy(24 weeks)
- Changes in intraocular pressure (IOP)(24 weeks)
- Response rate of changes in intraocular pressure (IOP)(24 weeks)
- Expression rate, number and change of Conjunctival Hyperemia(24 weeks)
- Expression rate, number and change of Macular Edema(24 weeks)
- Expression rate, number and change of Cystoid Macular Edema(24 weeks)
- Expression rate, number and change of Endothelial Cell Count(24 weeks)
- Expression rate, number and change of Central Corneal Thickness(24 weeks)