A Safety and Efficacy Study of OPTIVE FUSION™ With VISMED® Multi for the Management of Dry Eye
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 80
- 主要终点
- Change From Baseline in Global Ocular Staining Score in the Study Eye
研究概览
简要总结
This study will evaluate the safety and efficacy of OPTIVE FUSION™ compared to VISMED® Multi for the management of dry eye.
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
- Single (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
- •Use of artificial tears for dry eye in both eyes for at least 3 months
- •Use of preservative-free artificial tears at least twice daily for 2 weeks;
排除标准
- •Cataract, laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK) surgery in the last 12 months
- •Use of punctal plugs or contact lenses in the last month
- •Active ocular allergy within last 2 years
- •Best corrected visual acuity (BCVA) less than 20/200 in either eye
研究组 & 干预措施
OPTIVE FUSION™
1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
干预措施: carboxymethylcellulose 0.5%/glycerin 0.9% (Drug)
VISMED® Multi
1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
干预措施: sodium hyaluronate 0.18% (Drug)
结局指标
主要结局
Change From Baseline in Global Ocular Staining Score in the Study Eye
时间窗: Baseline, Day 35
Global ocular staining of the study eye was graded from 0 to 15 and was the sum of corneal fluorescein staining severity, nasal conjunctiva lissamine green staining severity, and temporal conjunctiva lissamine green staining severity. Staining of the cornea followed ocular administration of fluorescein dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Staining of the conjunctiva followed ocular administration of lissamine green dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Conjunctival staining was evaluated in two zones, nasal and temporal.
次要结局
- Subject Global Assessment of Treatment Efficacy on a 5-Point Scale(Baseline, Day 35, Month 3)
- Change From Baseline in Tear Break-up Time (TBUT) in the Study Eye(Baseline, Day 35)
- Change From Baseline in Ocular Surface Disease Index© (OSDI) Score(Baseline, Day 35)
- Change From Baseline in the Schirmer Test in the Study Eye(Baseline, Day 35)
- Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale(Day 35, Month 3)
- Conjunctival Hyperaemia in the Study Eye(Baseline, Day 35, Month 3)
- Subject Assessment of Dry Eye Symptoms on a 5-Point Scale(Baseline, Day 35, Month 3)
- Subject Assessment of Treatment Acceptability on a 5-Point Scale(Day 35)
- Change From Baseline in Global Ocular Staining Score in the Study Eye(Baseline, Month 3)
- Change From Baseline in Conjunctival Staining in the Study Eye(Baseline, Day 35, Month 3)
- Study Product Use(Day 8, Day 35, Month 3)
- Work Productivity and Activity Impairment Questionnaire Score(Baseline, Day 35, Month 3)
- Change From Baseline in Corneal Staining in the Study Eye(Baseline, Day 35, Month 3)