A Multicenter, Double-masked, Randomized Study to Compare the Safety and Efficacy of the OM3 Tear Formulation With REFRESH OPTIVE® ADVANCED Unit Dose for 3 Months in Patients With Dry Eye Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 242
- 试验地点
- 13
- 主要终点
- Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score
研究概览
简要总结
This study will evaluate the safety and efficacy of a new eye drop formulation 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
- •Used artificial tears for dry eye
- •Visual acuity of at least 20/32 (while wearing glasses, if necessary).
排除标准
- •Use of contact lenses in the last 3 months, or anticipated use of contact lenses during the study
- •Herpes keratitis in the last 6 months
- •Cataract surgery, laser-assisted in situ keratomileusis [LASIK], or photorefractive keratectomy, within the last 6 months
研究组 & 干预措施
OM3 Tear
Carboxymethylcellulose based eye drop [Omega-3 (OM3) Tear] administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
干预措施: Carboxymethylcellulose Based Eye Drop (Drug)
REFRESH OPTIVE® ADVANCED
Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
干预措施: Carboxymethylcellulose Sodium 0.5% (Drug)
结局指标
主要结局
Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score
时间窗: Baseline, Day 90
The OSDI© consists of 12 questions the patient is asked measuring the presence of ocular symptoms. Each of the 12 questions was assessed using a 5-point scale where 0=none of the time and 4=all of the time. The score is converted to a 0 to 100-point score where 0 is no symptoms and 100 is most symptoms. A negative change from Baseline indicates improvement.
次要结局
- Change From Baseline in the Schirmer Test(Baseline, Day 90)
- Change From Baseline in Tear Break-up Time (TBUT)(Baseline, Day 90)
- Change From Baseline in Corneal Staining Score(Baseline, Day 90)
- Change From Baseline in Conjunctival Staining Score(Baseline, Day 90)