A Multi-Center, Randomized, Double-Masked, Vehicle and Active Controlled, Parallel-Group 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
- 397
- 主要终点
- Mean Ocular Itching at Onset of Action
研究概览
简要总结
The purpose of this study was to assess the safety and efficacy of AL-4943A ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis using the Conjunctival Allergen Challenge (CAC) model.
详细描述
This study consisted of 5 Visits. Eligible patients underwent allergy testing using the Conjunctival Allergen Challenge (CAC) model, which reproduces the signs and symptoms of Seasonal Allergic Conjunctivitis by replicating the natural disease process. Patients demonstrating a positive reaction to the CAC at Visit 1 (screening) and Visit 2 (confirmatory) were randomized to treatment at Visit 3 (Day 0). The test article was instilled at Visit 3, with treatment efficacy CAC performed at 24 hours duration of action. The test article was instilled again at Visit 4 (Day 14), with treatment efficacy CAC performed at 16 hours duration of action. The test article was instilled a final time at Visit 5 (Day 21), with treatment efficacy performed at onset of action.
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
- Triple (Participant, 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
- •Able to be dosed in both eyes, able and willing to make the required study visits and to follow instructions.
- •Diagnostic skin test indicative of allergy for cat hair, cat dander, grasses, ragweed, dust mite, dog dander, cockroach and/or trees within 24 months of Visit
- •History of seasonal or perennial allergic conjunctivitis for at least 1 year prior to Visit
- •Positive bilateral CAC response at Visit 1 and Visit
- •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 requiring frequent use (> 4 days per week) of artificial tears, gels or lubricants, presence of punctal plugs, use of Restasis®, or topical ocular corticosteroids for dryness of eyes.
- •Presence of active blepharitis, active meibomian gland dysfunction, active rosacea affecting the ocular adnexa, follicular conjunctivitis, iritis, preauricular lymphadenopathy, ocular irritation not due to ocular allergy, or any other clinically significant ophthalmic abnormality that may affect the study outcomes.
- •Presumed or actual ocular infection (bacterial, viral or fungal) or history of ocular herpes in either eye as determined by patient history and/or examination within 30 days of Visit
- •Presence of any chronic ocular degenerative condition or active intra-ocular inflammation in either eye that in the opinion of the Investigator is likely to advance/worsen during the time course of the study.
- •Any contraindications or hypersensitivities to the use of the study medication or their components.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
AL-4943A
AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
干预措施: AL-4943A ophthalmic solution (Drug)
Vehicle
AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
干预措施: AL-4943A vehicle (Drug)
Pataday
Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
干预措施: Olopatadine hydrochloride ophthalmic solution, 0.2% (Drug)
结局指标
主要结局
Mean Ocular Itching at Onset of Action
时间窗: 3, 5, and 7 minute timepoints, post-CAC on Day 21 of receiving treatment
A treatment efficacy CAC was performed 27 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=incapacitating itch). Average of ocular itching score over both eyes was analyzed.
Mean Ocular Itching at 16 Hours Duration of Action
时间窗: 3, 5, and 7 minute timepoints, post-CAC on Day 14 of receiving treatment
A treatment efficacy CAC was performed 16 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=incapacitating itch). Average of ocular itching score over both eyes was analyzed.
次要结局
- Mean Conjunctival Redness at Onset of Action(7, 15, and 20 minute timepoints, post-CAC on Day 21 of receiving treatment)
- Mean Conjunctival Redness at 16 Hours Duration of Action(7, 15, and 20 minute timepoints, post-CAC on Day 14 of receiving treatment)
- Mean Total Redness at 24 Hours Duration of Action(7, 15, and 20 minute timepoints, post-CAC on Day 1 of receiving treatment)
- Mean Ocular Itching at 24 Hours Duration of Action(3, 5, and 7 minute timepoints, post-CAC on Day 1 of receiving treatment)
- Mean Conjunctival Redness at 24 Hours Duration of Action(7, 15, and 20 minute timepoints, post-CAC on Day 1 of receiving treatment)