A Multicenter, Prospective, Randomized, Double-Masked, Phase 2 Study Evaluating the Safety, Tolerability, and Efficacy of Topical AG-86893 in Patients With Pterygium
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 6
- 主要终点
- Change From Baseline in Overall Conjunctival Hyperemia Score
研究概览
简要总结
A pterygium is a wing-shaped, benign tissue growth which forms on the surface of the conjunctiva and grows towards the cornea. It can eventually lead to vision impairment. The precise cause of pterygium formation is unknown but new blood vessel growth and fibroblastic structures are characteristics of the disease. AG-86893 is an eye drop being developed to treat hyperemia (redness) and growth of the pterygium.
Hypothesis
- AG-86893 dosed three times daily for 28 consecutive days has an acceptable safety profile as measured by the incidence and severity of adverse events (AEs) compared with vehicle
- At least 1 concentration of AG-86893 is effective, as measured by the mean change from baseline in conjunctival hyperemia (redness), compared with vehicle
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
- •Good health with no clinically significant findings based on the medical history, electrocardiogram, vital signs, blood chemistry, hematology, and urinalysis findings, as determined by the investigator
- •Females of childbearing potential must have a negative pregnancy test at baseline and must be on established, adequate contraception and males must use condoms if their partner is of childbearing potential and their female partner should also use an additional effective means of contraception, or they must agree to abstain from sexual intercourse with a female partner for the duration of the study; contraception should be continued for 3 months after the last dose.
- •Presence of pterygium with associated conjunctival hyperemia (redness) of grade ≥2 as assessed by a central reading center.
排除标准
- •History or presence of any ocular diseases other than pterygium or its sequelae (after-effects), including neoplasia (uncontrolled overgrowth)
- •Diagnosis of ocular hypertension or glaucoma requiring use of intraocular pressure-lowering medication
- •Use of contact lenses during the study in the study eye
- •History or evidence of ocular surgeries in the study eye at any time
- •History of liver dysfunction or current abnormal liver enzymes
- •Pregnancy, plans for pregnancy, or breastfeeding during the study
研究组 & 干预措施
Vehicle Eye Drops
One drop, three times daily to the study eye for 28 days
干预措施: Vehicle Eye Drops (Drug)
0.1% AG-86893 Eye Drops
One drop, three times daily to the study eye for 28 days
干预措施: 0.1% AG-86893 Eye Drops (Drug)
0.3% AG-86893 Eye Drops
One drop, three times daily to the study eye for 28 days
干预措施: 0.3% AG-86893 Eye Drops (Drug)
结局指标
主要结局
Change From Baseline in Overall Conjunctival Hyperemia Score
时间窗: Baseline and Day 28
Assessed by digital ocular photography; each quadrant of the eye (superior, inferior, nasal, temporal) will be scored using a 5-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe) and graded by a reading center. The overall conjunctival score is the average of the four quadrants. Assessments are made by subtracting the score at Baseline from the score on Day 28. An increase in value indicates worsening of hyperemia, while a decrease indicates improvement.
次要结局
- Change From Baseline in Conjunctival Hyperemia Score in the Quadrant With the Pterygium(Baseline and Day 28)