Phase 3, Efficacy and Safety Study of AL-4943A Ophthalmic Solution, 0.77% in Patients With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge (CAC) Model
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 902
- 主要终点
- Mean Ocular Itching at 24 Hours Duration of Action
研究概览
简要总结
The purpose of this study is to evaluate an ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis using the Conjunctival Allergen Challenge (CAC) model.
详细描述
Enrolled participants will be tested for the presence of common allergies using the Conjunctival Allergen Challenge (CAC) model. Drops of increasing concentration of a solubilized allergen will be instilled in both eyes until a positive reaction occurred. The test will be repeated to confirm the allergic reaction. Participants with confirmed reactions will be administered the test article (Day 0) and undergo a CAC 24 hours post-instillation (Day 1). On Day 14, participants will be administered the test article and undergo an additional CAC.
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
- Double (Participant, Investigator)
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
- •Able to be dosed in both eyes, able and willing to make the required study visits and to follow instructions.
- •Negative urine pregnancy test if female of childbearing potential and use adequate birth control throughout the study period.
- •Diagnostic skin test indicative of allergy for cat hair, cat dander, grasses, ragweed, dust mite, dog dander, cockroach and/or trees within 24 months prior to Visit 1 or at Visit
- •History of seasonal or perennial allergic conjunctivitis for at least 1 year prior to Visit
- •Best-corrected visual acuity of 55 or greater in each eye as measured by ETDRS (letters read method).
- •Manifest a positive bilateral Conjunctival Allergen Challenge (CAC) test response.
- •Willing to discontinue contact lens wear for at least 72 hours prior to Visit 1 and throughout the study.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Known history or presence of persistent dry eye syndrome, or currently requires frequent use of artificial tears, gels or lubricants, presence of punctal plugs, use of Restasis®, or topical ocular corticosteroids for dryness of eyes.
- •Presence of an ocular condition that may affect the study outcomes.
- •History or evidence of ocular surgery (including refractive procedures such as LASIK, PRK and RK) within 6 months of Visit
- •Presence of signs/symptoms of active allergic conjunctivitis at the start of Visits 1, 2, 3A, or
- •History of anaphylactic reaction to any allergens used in this study.
- •Current evidence or recent (within 6 months) history of severe, unstable, or uncontrolled medical conditions and/or other relevant systemic diseases.
- •Use of any disallowed medication without protocol-specified washout period prior to Visit 1, or during the study.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
AL-4943A
AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
干预措施: AL-4943A ophthalmic solution (Drug)
PATADAY
Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
干预措施: Olopatadine hydrochloride ophthalmic solution, 0.2% (Drug)
PATANOL
Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
干预措施: Olopatadine hydrochloride ophthalmic solution, 0.1% (Drug)
Vehicle
AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
干预措施: AL-4943A ophthalmic solution vehicle (Drug)
结局指标
主要结局
Mean Ocular Itching at 24 Hours Duration of Action
时间窗: Day 1 (3, 5, and 7 minutes post-CAC)
A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed.
Mean Ocular Itching at Onset of Action
时间窗: Day 14 (3, 5, and 7 minutes post-CAC)
A treatment efficacy CAC was performed 27 minutes after drop installation. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed.
次要结局
- Mean Conjunctival Redness at Onset of Action(Day 14 (7, 15, and 20 minutes post-CAC))
- Mean Total Redness at 24 Hours Duration of Action(Day 1 (7, 15, and 20 minutes post-CAC))
- Proportion of Itch Responders at 24 Hours Duration of Action(Day 1)
- Mean Total Redness at Onset of Action(Day 14 (7, 15, and 20 minutes post-CAC))
- Proportion of Ocular Itching Responders at Onset of Action(Day 14)
- Mean Conjunctival Redness at 24 Hours Duration of Action(Day 1 (7, 15, and 20 minutes post-CAC))