A Phase 3 Multicenter, Randomized, Controlled, Double-Masked Study of Safety and Efficacy of Sodium Hyaluronate Ophthalmic Solution, 0.18% in Dry Eye Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,936
- 主要终点
- Change From Baseline in Lissamine Green Staining (LGS) Total Score at Day 7
研究概览
简要总结
The purpose of this study was to determine if Sodium Hyaluronate, 0.18% is effective in treating the signs and symptoms of 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Documented history of dry eyes for at least 3 months.
- •Ocular discomfort due to dry eyes.
- •Presence of corneal and conjunctival staining.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Women who are pregnant or lactating.
- •Contact lens wear within 1 week before Screening and during the study.
- •Ocular surgery (of any type, including laser surgery) or ocular trauma within the 4 months prior to Screening.
- •Punctal plugs or punctal occlusion initiated within 3 months of screening
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Sodium Hyaluronate
Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
干预措施: Sodium Hyaluronate Ophthalmic Solution, 0.18% (Drug)
Vehicle
Inactive ingredients, 1-2 drops instilled in each eye 3-6 times a day for 14 days
干预措施: Vehicle (Other)
结局指标
主要结局
Change From Baseline in Lissamine Green Staining (LGS) Total Score at Day 7
时间窗: Baseline, Day 7
The investigator instilled an ophthalmic dye on the eye and rated staining in three areas (cornea, nasal, and temporal conjunctiva). Staining was rated on a 5-point scale from 0 to 4 (0=0% to 4=\>45%). The LGS Total Score (0-12) is the sum of the three individual ratings. A more negative change indicates a greater amount of improvement.
Change From Baseline in Global Symptom Frequency (GSF) Total Score at Day 7
时间窗: Baseline, Day 7
The subject completed a questionnaire and rated the frequency of five common dry eye symptoms. Frequency was rated on a 4-point scale from 0 to 3 (0=never to 3=constantly). The GSF Total Score (0-15) is the sum of the five individual ratings. A more negative change indicates a greater amount of improvement.
次要结局
- Change From Baseline in LGS Total Score at Day 14(Baseline, Day 14)
- Change From Baseline in GSF Total Score at Day 14(Baseline, Day 14)
- Percentage Change From Baseline in Corneal Fluorescein Staining (CFS) Total Score(Baseline, up to Day 14)
- Percentage Change From Baseline in Schirmer I Score(Baseline, up to Day 14)
- Percentage Change From Baseline in Global Symptom Intensity (GSI) Total Score(Baseline, up to Day 14)
- Percentage Change From Baseline in Global Symptom Composite Index (GSCI) Score(Baseline, up to Day 14)
- Proportion of Improved Scores on the Global Impact on Dry Eye Syndrome on Daily Life (GIDL) Rating(Baseline, Up to Day 14)