A Multicenter, Vehicle-controlled, Randomized Study to Evaluate the Safety, Tolerability, Systemic Pharmacokinetics, and Pharmacodynamics of AXR-159 Ophthalmic Solution 3 mg/mL, 30 mg/mL, and 50 mg/mL in Patients With Dry Eye Disease (DED)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Eye Dryness
研究概览
简要总结
Protocol AXR201701 is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study carried out in 2 stages (Stage 1: AXR-159 Ophthalmic Solution (30 mg/mL or 50 mg/mL); Stage 2: AXR-159 Ophthalmic Solution (3 mg/mL, 30 mg/mL or 50 mg/mL) in approximately 430 patients diagnosed with dry eye disease (DED).
详细描述
Protocol AXR201701 is designed with 2 stages. For both Stages 1 and 2, patients with signs and symptoms of DED will be randomly assigned to receive either a single concentration of AXR-159 Ophthalmic Solution or AXR-159 Ophthalmic Solution Vehicle.
A screening visit will be followed by a baseline period where subjects will dose with AXR-159 Ophthalmic Solution Vehicle for 14 days. At the end of the baseline period patients who still exhibit signs and symptoms of DED will be enrolled into a 3-month double-masked treatment period.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Male or female, 18 years of age or older at screening visit
- •Best-corrected visual acuity (BCVA) of 20/100 or better (Snellen equivalent), using the logarithm of the minimum angle of resolution (LogMAR) in each eye
- •Reported history of dry eye for at least 6 months
- •Corneal fluorescein staining score ≥ 2
- •Eye dryness score ≥ 40
- •Total Ocular Surface Disease Index (OSDI) score > 18
排除标准
- •Uncontrolled ocular disease (except for dry eye disease/keratoconjunctivitis sicca) or uncontrolled systemic disease
- •Patient has glaucoma, ocular hypertension, on IOP-lowering medications or have previously undergone any glaucoma laser or surgical procedure.
- •Corneal abnormality or disorder that impacts normal spreading of the tear film (keratoconus, pterygia, scarring) or compromised corneal integrity
- •BCVA worse than 20/100 in either eye
- •Current use of punctal plugs, anticipated insertion during the study, or a history of punctal cautery in either eye
- •Keratoconjunctivitis sicca secondary to destruction of conjunctival goblet cells
- •Patients with clinically significant inflammation of the lid margin such as anterior blepharitis or ocular rosacea
- •Recent (within the past 3 months) ocular surgery, trauma or herpes
- •Use of contact lenses in either eye within one month prior to the screening visit or anticipated use during the study
研究组 & 干预措施
AXR-159 Ophthalmic Solution 3 mg/mL
AXR-159 Low Dose
干预措施: AXR-159 (Drug)
AXR-159 Ophthalmic Solution 30 mg/mL
AXR-159 Mid Dose
干预措施: AXR-159 (Drug)
AXR-159 Ophthalmic Solution 50 mg/mL
AXR-159 High Dose
干预措施: AXR-159 (Drug)
AXR-159 Ophthalmic Solution Vehicle
Control Group
干预措施: Vehicle (Drug)
结局指标
主要结局
Eye Dryness
时间窗: Month 3
Change from baseline in Eye Dryness score on a subject level across both eyes. Using the visual analogue scale (VAS) subjects rated eye dryness by placing a vertical mark on the horizontal line to indicate the level of discomfort with a range of 0 to 100. 0% corresponds to "no dryness" (no discomfort) and 100% corresponds to "maximal dryness" indicating maximal discomfort. A greater negative change from baseline score means a better outcome.
Inferior Corneal Staining Score
时间窗: Month 3
Change from Baseline in Ora Calibra® Corneal and Conjunctival Staining Scale with a range from 0 to 4 (0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe) in the study eye. Higher negative scores mean a better outcome.
次要结局
- Total Ocular Surface and Disease Index (OSDI) © for Dry Eye(Month 3)
- Schirmer's Test(Month 3)
- Tear Film Break-up Time (TBUT)(Month 3)
- Conjunctival Redness Score(Month 3)
- Total Lissamine Green Conjunctival Staining(Month 3)