Oral Omega-3 Fatty Acids in the Treatment of Dry Eye Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Change From Baseline of the Ocular Surface Disease Index Score at Day 45
研究概览
简要总结
The investigators hypothesize that oral omega-3-acid ethyl esters (Lovaza, GlaxoSmithKline, Research Triangle Park, NC) will decrease dry-eye related symptoms as well as clinical markers associated with dry eye disease (Schirmer-1 test values, positive vital staining with lissamine green, and fluorescein tear break-up time) when compared to administration of placebo.
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
- •Age > 18 years
- •Typical symptoms of dry eye (photophobia, burning, foreign body sensation, blurred vision improved with blinking)
- •Schirmer Test < 8 mm/5 minutes
- •Fluorescein tear break-up time < 8 seconds
- •No current use of dry eye treatment (except artificial lubrication)
- •Signature on consent form
排除标准
- •Infectious keratoconjunctivitis or inflammatory disease unrelated to dry eye
- •Eyelid or eyelash abnormalities
- •Alteration of the nasolacrimal apparatus
- •Treatment with drugs affecting tearing
- •Concomitant ocular therapies
- •Topical ophthalmic steroids taken during the 4 weeks before the study
- •Pregnant/breast-feeding women
- •History of liver disease
- •History of fish and/or shellfish allergy or hypersensitivity
- •History of corn allergy or hypersensitivity
- •Treatment with systemic anticoagulation therapy
- •Patients with bleeding disorders or those receiving anticoagulation (e.g., warfarin, enoxaparin, dipyridamole, clopidogrel)
研究组 & 干预措施
Corn oil capsule
干预措施: Placebo corn oil capsule (Drug)
Omega-3-acid ethyl esters
干预措施: Oral Omega-3-acid ethyl esters (Drug)
结局指标
主要结局
Change From Baseline of the Ocular Surface Disease Index Score at Day 45
时间窗: Baseline and Day 45
The Ocular Surface Disease Index Score is a validated, scored questionnaire that measures subjective symptoms of dry eye. Possible scores range from 0 (no symptoms of dry eye) to 100 (severest symptoms of dry eye). Change = (Day 45 score - Baseline score)
次要结局
- Change From Baseline of Schirmer-1 Test Value at Day 45(Baseline and Day 45)
- Change From Baseline of Lissamine Green Staining Score at Day 45(Baseline and Day 45)
- Change From Baseline of Fluorescein Tear Break-Up Time (Seconds) at Day 45(Baseline and Day 45)
研究者
David Liang
Physician
Milton S. Hershey Medical Center