Managing Dry Eye in Rheumatoid Arthritis Patients With Dual-Polymer Hydroxypropyl Guar-and Hyaluronic Acid Containing Lubricant Eye Drops
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Ocular Surface Disease Index (OSDI)
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy of hydroxypropyl guar-and hyaluronic acid containing lubricant eye drops in rheumatoid arthritis patients . The main question it aims to answer is:
• whether adding hydroxypropyl guar-and hyaluronic acid containing lubricant eye drops to steroid-based dry eye therapy improves dry eye symptoms in rheumatoid arthritis patients after 1 month.
Participants with rheumatoid arthritis will be treat with SYSTANE™ Hydration Lubricant Eye Drops (1-2 drops 4 times a day) and 0.1% Fluorometholone (1-2 drops 3 times a day) in both eyes for 12 weeks
详细描述
This is a prospective, single-center study designed to assess the efficacy of adding SYSTANE™ Hydration Lubricant Eye Drops on dry eyes secondary to rheumatoid arthritis (RA) patients. This study will enroll 40 dry-eye RA participants to achieve 32 evaluable participants for analysis. There are 4 phases throughout the whole study, including the screening phase (Day -30 to -14 [Visit 1]), the wash-out phase (Day -14±3 days to Day 0), baseline (Day 0 [Visit 2]), and the follow-up phase (Days 28±7 to 84±7 days [Visits 3 to 5]).
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 patients in any race, 18 years (inclusive) or older.
- •Participants with a confirmed diagnosis of stable RA, determined by a rheumatologist according to the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria. The systemic conditions of the enrolled patients were well controlled by their rheumatologists during the study period.
- •Patients diagnosed with the dry eye disease (DED) by an ophthalmologist based on the Tear Film & Ocular Surface Society Dry Eye Workshop II (TFOS DEWS II) dry eye severity grading diagnostic scheme criteria.
- •At screening, dry eye associated-RA patients on a steroid-based therapy who are stable in dry eye severity but experience/complain of persistent dry eye symptoms.
- •The results within the range of the following assessments will be defined as stable DED with persistent dry eye symptoms at the screening phase:
- •CFS score (NEI scale) 1-
- •OSDI score 13-
- •In addition, patients should fulfill the required range of the following assessments at Visit 2:
- •OSDI 13-50 scores
- •Non invasive TBUT 3-10 seconds
- •Schirmer's test (without anesthesia) 3-10 mm in 5 minutes
- •CFS (NEI scale) 1-12 scores
- •Patients instilled the same dry eye therapeutic regimen of steroid eye drops and/or artificial tears (but naïve to HA-containing eye drops) for at least 3 months before the screening phase.
排除标准
- •Any known allergy to any of the study medications, conjunctival allergy or infectious disease, history of ocular chemical or thermal burn, Stevens-Johnson syndrome (SJS) or ocular pemphigoid, eyelid or lacrimal disease, any ocular operation within 6 months, grat versus host disease, non-dry-eye ocular inflammation, trauma, or presence of uncontrolled systemic disease.
- •Patients who have a history of intraocular, lacrimal or ocular surface surgery other than cataract extraction.
- •Patients who received cataract extraction surgery within 6 months of screening or patients who are planning to receive eye surgery during the study period.
- •Patients who wear corneal contact lens, have history of other severe systemic diseases, or other conditions, in the Investigator's opinion, may preclude enrollment.
- •Patients who received poly-pharmacy treatment for the dry eye before enrollment: DED requires topical ophthalmic treatment other than artificial tears and steroids (i.e., exclude auto-serum drops, diquafosol, and cyclosporine eye drops).
- •Patients with ocular conditions other than DED requiring topical ophthalmic treatment.
- •Patients who had experienced anti-rheumatic medication change within 3 months before the screening.
研究组 & 干预措施
Hyaluronic Acid/Hydroxypropyl Guar arm
Systane Hydration® MD
干预措施: SYSTANE™ Hydration Lubricant Eye Drops (Drug)
结局指标
主要结局
Ocular Surface Disease Index (OSDI)
时间窗: Change from baseline to the first month.
The OSDI score is a 12-item patient-reported outcomes questionnaire with an overall score ranging from 0 to 100 to assess ocular surface symptoms, and the subjects can be categorized as having a normal (0-12), mild (13-22), moderate (23-32), or severe (33-100) ocular surface disease based on their OSDI score.
次要结局
- Schirmer's test scores(Change from baseline to second and third month)
- Tear meniscus height(Change from baseline to second and third month)
- Ocular Surface Disease Index (OSDI)(Change from baseline to second and third month)
- Corneal fluorescein staining (CFS) scores using National Eye Institute scale(Change from baseline to second and third month)
- Non-invasive tear break-up time (TBUT)(Change from baseline to second and third month)
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