Safety and Efficacy Study of New Eye Drop Formulations With Refresh Tears® 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
- 305
- 主要终点
- Change From Baseline in Ocular Surface Disease Index© (OSDI) Score
研究概览
简要总结
This study will investigate the safety, efficacy and acceptability of two new eye drop formulations compared with Refresh Tears® 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
- •Current use of an artificial tear product at least twice daily for at least 3 months, on average
- •Ability/agreement to continue wearing existing spectacle correction (glasses) during study
排除标准
- •Anticipated contact lens wear during study or contact lens use within 6 months
- •Active ocular infection or allergy
- •Use of any topical ophthalmic medications (eg, topical ophthalmic steroids, glaucoma drops) within 2 weeks
- •Use of any topical cyclosporine products within 3 months
研究组 & 干预措施
New Eye Drop Formulation 1
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
干预措施: carboxymethylcellulose sodium based New Eye Drop Formulation 1 (Drug)
New Eye Drop Formulation 2
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
干预措施: carboxymethylcellulose sodium based New Eye Drop Formulation 2 (Drug)
Refresh Tears®
1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
干预措施: carboxymethylcellulose sodium based Eye Drops (Drug)
结局指标
主要结局
Change From Baseline in Ocular Surface Disease Index© (OSDI) Score
时间窗: Baseline, Day 90
The OSDI is a questionnaire consisting of 12 questions assessing severity of dry eye using a 5-point scale where 0=none of the time to 4=all of the time. The total score is the sum of the individual scores normalized (standardized) to a severity scale of 0=no symptoms (best score) to 100=maximum severity (worst score). A negative change from Baseline indicated improvement.
次要结局
- Change From Baseline in Visual Analog (VAS) Symptom Scale: Dryness(Baseline, Day 90)
- Percentage of Participants Much Better or Better in Near Visual Acuity (Low Contrast)(Baseline, Day 90)
- Percentage of Participants Much Better or Better in Near Visual Acuity (High Contrast)(Baseline, Day 90)
- Change From Baseline in Tear Break-Up Time (TBUT)(Baseline, Day 90)
- Change From Baseline in Corneal Staining(Baseline, Day 90)
- Change From Baseline in Conjunctival Staining(Baseline, Day 90)
- Change From Baseline in Schirmer Test(Baseline, Day 90)