Effect of Cequa™ in Subjects With Dry Eye Disease That Is Currently Inadequately Controlled While on Cyclosporine 0.05% Ophthalmic Emulsion
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 5
- 主要终点
- Mean Change in Baseline in Total Corneal Fluoroscein Staining Score
研究概览
简要总结
This is a Phase 4, multicenter, single arm, 12 week study in subjects with dry eye disease, which is inadequately controlled by cyclosporine 0.05% ophthalmic emulsion.
详细描述
This is a phase 4, multicenter, open-label, single-arm, 12-week study of subjects with dry eye disease that is inadequately controlled by cyclosporine (CsA) 0.05% ophthalmic emulsion. Subject enrollment will be classified by evidence of dry eye disease (ie, signs, symptoms, or both signs and symptoms). Treatment will be one drop of CsA 0.09% ophthalmic solution (Cequa) in each eye twice daily (BID) for 12 weeks. The study hypothesis is that CsA 0.09% ophthalmic solution will show improved clinical benefit in subjects whose dry eye signs and/or symptoms are inadequately controlled while on CsA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or female subjects with a history of bilateral dry eye disease for a period of at least 3 months.
- •Aged of at least 18 years.
- •Subjects with total corneal fluorescein staining ≥6 or corneal fluorescein staining in an individual zone ≥2 as per National Eye Institute Grading Scale.
- •Subjects with modified symptom assessment in dry eye global symptom score, ≥40 using visual analogue scale.
- •Subjects with best-corrected visual acuity 20/200 or better in both eyes at the Screening/Baseline visit
排除标准
- •Subjects who have used cyclosporin 0.05% ophthalmic emulsion in both eyes for less than 3 months prior to the Screening/Baseline visit.
- •Subjects with history of treatment failure with cyclosporin 0.05% ophthalmic emulsion.
- •Subjects who have active seasonal and/or perennial allergic conjunctivitis in either eye.
- •Subjects who had already Use initiated any systemic or topical ocular medication.
研究组 & 干预措施
CequaTM (Cyclosporine 0.09%) ophthalmic solution
干预措施: CequaTM (Cyclosporine 0.09%) ophthalmic solution (Drug)
结局指标
主要结局
Mean Change in Baseline in Total Corneal Fluoroscein Staining Score
时间窗: Week12
Scale for Corneal Staining as defined by the FDA/NEI: 0-4 (0-no staining, 4-severe staining). The higher number indicates more severe. The lower the number indicates less severe staining on the cornea
Change From Baseline in Modified Dry Eye Scoring.
时间窗: Week12
Based on questionnaire asked to subjects (sign and symptoms), modified symptom of dry eye score (range 0 to 100) will be assessed. Increase in score will indicate severity in the symptoms.
次要结局
- Changes From Baseline in Central Corneal Staining Score(Week 12)
- Mean Change From Baseline in Frequency of Artificial Tear Product Use.(Week 12)
- Mean Change in Baseline for Conjunctival Staining Assessment(Week 12)
- Mean Change in Baseline for Tear Osmolarity Score for Both Eyes(Week 12)
- Schirmer's Test Score(Week 12)
- Percentage of Subjects Who Prefer Study Treatments Over Prior Treatment.(Week 12)