Comparison of Different Hyaluronic Acid-containing Artificial Tears on the Ocular Surface Disease in Patients With Post-cataract Surgery Dry Eye
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Corneal fluorescein staining (CFS) score
研究概览
简要总结
To compare the effects of hydroxypropyl guar (HPG)/hyaluronic acid (HA)- and carboxymethylcellulose (CMC)/HA-based lubricant eye drops on subjective and objective outcomes in dry eye disease (DED) patients after cataract surgery.
详细描述
This is a prospective, open-label, assessor-masked, interventional, randomized controlled study. A total of 70 post-cataract surgery dry-eye subjects are planned to be enrolled after eligibility confirmation at Week 1 post-operative (post-op). The subjects will then be randomized in a 1:1 ratio to either HPG/HA (Systane HYDRATION® ) or CMC/HA (Optive Fusion®) group.
From Week 1 to 3 (1st to 4th week post-op), the HPG/HA group will receive Systane HYDRATION® Preservative-Free Lubricant Eye Drops whereas the CMC/HA group will receive Optive Fusion® Lubricant Eye Drops (Unit Dose). Both groups will receive 1-2 drops of artificial tears 4 times daily for 3 weeks.
There are three visits scheduled in this study, i.e., screening, Week 1, and Week 3. The subjects will return to the study sites during these visits for efficacy and safety assessments.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients of any race, 20 years or older who are scheduled for unilateral cataract surgery.
- •DED patients whose symptoms and signs are aggravated at baseline assessment after cataract surgery will be eligible for this study. Postoperative dry eye diagnosis criteria at baseline assessment:
- •OSDI score >14.8* (*Eligible subject mandatory required);
- •positive CFS* (*Eligible subject mandatory required);
- •Schirmer's test score ≤10 mm in 5 minutes (min) (without anesthesia);
- •TBUT ≤5 seconds (sec)
排除标准
- •Patients with allergy to any of the study medications, conjunctival allergy or infectious disease, history of ocular chemical or thermal burn, Stevens-Johnson syndrome or ocular pemphigoid, glaucoma or ocular hypertension, eyelid or lacrimal disease, any ocular operation within 3 months, graft-versus-host disease (GVHD), non-dry-eye ocular inflammation, trauma, or presence of uncontrolled systemic disease.
- •Before enrollment, corneal contact lens wear, history of severe systemic disease, or other conditions in the Investigator's opinion precluded enrollment.
- •Patients will be withdrawn from the study if they experience complications during surgery, or post-surgical ocular hypertension, endophthalmitis, or infectious keratitis.
研究组 & 干预措施
HPG/HA group
Systane HYDRATION®
干预措施: Systane HYDRATION® Preservative-Free Lubricant Eye Drops (Drug)
CMC/HA group
Optive Fusion®
干预措施: Optive Fusion® Lubricant Eye Drops (Unit Dose) (Drug)
结局指标
主要结局
Corneal fluorescein staining (CFS) score
时间窗: Change from baseline to Weeks 1 and 3
The CFS will be evaluated by external eye photography using the National Eye Institute (NEI) staining grid in which a score of 0 (normal) to 3 (severe) will be assigned to each of the 5 corneal regions (nasal, central, temporal, superior, and inferior). The CFS score will range between 0 and 15, and the maximum score of 15 indicates severe epitheliopathy.
次要结局
- Schirmer's test (without anesthesia)(Change from baseline to Weeks 1 and 3)
- Ocular Surface Disease Index (OSDI)(Change from baseline to Weeks 1 and 3)
- Slit-lamp examination(Change from baseline to Weeks 1 and 3)
- Tear break-up time (TBUT)(Change from baseline to Weeks 1 and 3)
- Central corneal sensitivity(Change from baseline to Weeks 1 and 3)
研究者
CHI-CHIN-SUN
Professor, School of Medicine Chang Gung University Taoyuan, Taiwan ; Doctor, Department of Ophthalmology, Chang Gung Memorial Hospital, Keelung, Taiwan
Chang Gung Memorial Hospital