Safety, Efficacy, Tolerability and Pharmacokinetics of AGN-223575 Ophthalmic Suspension in Patients With Dry Eye Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 236
- 试验地点
- 28
- 主要终点
- Change From Baseline in Conjunctival Redness Score in the Study Eye Using a 5-Point Scale
研究概览
简要总结
This study will evaluate the safety, efficacy, tolerability, and systemic pharmacokinetics of 3 different doses of topical ophthalmic AGN-223575 suspension compared to AGN-223575 vehicle in patients with dry eye disease.
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
- •Signs and symptoms of dry eye disease
- •Has used RESTASIS and/or artificial tears in both eyes twice a day for at least 60 days.
排除标准
- •History of glaucoma, or ocular hypertension
- •Diagnosis of ocular infection
- •Use of contact lenses in the past 14 days or expected use during the study
- •Use of any topical ophthalmic medications in the past 30 days
- •Use of corticosteroids in the past 30 days.
研究组 & 干预措施
AGN-223575 Dose A
1 drop of AGN-223575 Dose A ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose A ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days.
干预措施: AGN-223575 ophthalmic solution (Drug)
AGN-223575 Dose A
1 drop of AGN-223575 Dose A ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose A ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days.
干预措施: AGN-223575 vehicle ophthalmic solution (Drug)
AGN-223575 Dose B
1 drop of AGN-223575 Dose B ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose B ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days.
干预措施: AGN-223575 ophthalmic solution (Drug)
AGN-223575 Dose B
1 drop of AGN-223575 Dose B ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose B ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days.
干预措施: AGN-223575 vehicle ophthalmic solution (Drug)
AGN-223575 Dose C
1 drop of AGN-223575 Dose C ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose C ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days.
干预措施: AGN-223575 ophthalmic solution (Drug)
AGN-223575 Dose C
1 drop of AGN-223575 Dose C ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose C ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days.
干预措施: AGN-223575 vehicle ophthalmic solution (Drug)
AGN-223575 Vehicle
1 drop of Vehicle to AGN-223575 ophthalmic solution administered in each eye twice daily for 14 day followed by 1 drop of vehicle to AGN-223575 ophthalmic solution in each eye once daily for 7 days.
干预措施: AGN-223575 vehicle ophthalmic solution (Drug)
结局指标
主要结局
Change From Baseline in Conjunctival Redness Score in the Study Eye Using a 5-Point Scale
时间窗: Baseline, Day 14
Nasal and temporal bulbar conjunctival hyperemia were graded separately in each eye by the investigator under slit-lamp magnification by assigning a score of 0 to 4 for each quadrant based on comparison to the Allergan Dry Eye Redness Scale with photographic reference where: 0=Normal, vessels of bulbar conjunctiva are easily observed; 1=Trace redness; 2=Mild redness; 3=Moderate redness; 4=Severe redness, and each score is associated with a reference photo. For each eye, the study quadrant was determined by the greater (more severe) of the baseline redness scores for nasal and temporal bulbar conjunctival hyperemia as assessed using the Allergan Dry Eye Redness Scale. If the temporal score was greater than the nasal score, then the temporal quadrant was the study quadrant for the eye and was used to assess primary efficacy; otherwise the nasal quadrant was the study quadrant. A negative change from baseline (less redness) indicates improvement.
次要结局
- Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score Using a 5-Point Scale(Baseline, Day 14)
- Change From Baseline in Corneal Staining Score of the Study Eye Using a 6-Point Scale(Baseline, Day 14)
- Percentage of Participants With Complete Redness Response (Yes/No) in the Study Eye(Day 14)