A Study to Compare the Safety and Efficacy of a New Eye Drop Formulation With REFRESH PLUS® in Participants Following LASIK Refractive Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 148
- 主要终点
- Ocular Surface Disease Index© (OSDI) Score Using a 5-Point Scale
研究概览
简要总结
This study will compare the safety and efficacy of a new eye drop formulation with REFRESH PLUS® in participants following LASIK surgery.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients scheduled for LASIK surgery in both eyes.
排除标准
- •Any systemic medication use within 3 months of screening (including over the counter, herbal, prescription, or nutritional supplement) which may affect dry eye or vision
- •Use of topical eye medication other than prescribed for use in pre- or post-operative care
- •Use of RESTASIS® or other topical ophthalmic cyclosporine product within 6 months prior to Screening
- •Eye infection, inflammation, or allergy
- •Soft contact lenses in the previous 7 days or rigid contact lenses in the previous 30 days prior to LASIK surgery.
研究组 & 干预措施
New Eye Drop Formulation
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
干预措施: carboxymethylcellulose sodium based new eye drop formulation (Drug)
REFRESH PLUS®
1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
干预措施: carboxymethylcellulose sodium based eye drops (Drug)
结局指标
主要结局
Ocular Surface Disease Index© (OSDI) Score Using a 5-Point Scale
时间窗: Day 90
The OSDI© is a 12-question survey for patients to document their dry eye disease symptoms. Each question is rated on a 5-point scale (0=none of the time and 4 = all of the time). The scores are totaled over the 12 questions and normalized/converted to a score of 0-100 (0=no disability and 100=complete disability).
次要结局
- Change From Baseline in Corneal Staining in the Worse Eye(Baseline, Day 90)
- Change From Baseline in Tear Break-up Time (TBUT) in the Worse Eye(Baseline, Day 90)
- Change From Baseline in the Schirmer Test in the Worse Eye(Baseline, Day 90)
- Change From Baseline in Uncorrected Visual Acuity in the Worse Eye(Baseline, Day 90)