NCT02260960已完成2 期
The Influence of PRN Dry Eye Omega-3 Nutritional Regimen on Tear Osmolarity In Cases Of Dry Eye Disease.
Physician Recommended Nutriceuticals2 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2014年3月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Tear Osmolarity
研究概览
简要总结
The investigators hypothesize that oral omega-3-acid triglyceride form will decrease dry-eye related symptoms as well as clinical markers associated with dry eye disease (TearOsmolarity, Schirmer-1 test values, corneal staining, 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
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 and ≤ 90 at the time of informed consent
- •Subjects experiencing dry eye based on a global clinical assessment by the attending clinician, subject complaint of dry eye symptoms
- •Presence or History of Tear Osmolarity (Appendix 2) equal to or greater than 312 mOsm/L in at least one eye
- •Presence or History of Meibomian Gland Dysfunction (Grade 1 or 2) in at least one eye
排除标准
- •Allergy to fish oil or safflower oil
- •Clinically significant eyelid deformity or eyelid movement disorder that is caused by conditions such as notch deformity, incomplete lid closure, entropion, ectropion, hordeola or chalazia
- •Previous ocular disease leaving sequelae or requiring current topical eye therapy other than for DED, including, but not limited to: active corneal or conjunctival infection of the eye and ocular surface scarring Active ocular or nasal allergy
- •LASIK or PRK surgery that was performed within one year of the Screening Visit or at any time during the study
- •Ophthalmologic drop use within 2 hours of any study visits. Any OTC habitual artificial tear should be continued at the same frequency and no change in drop brand
- •Contact lens wear within 12 hours of any study visits
- •Pregnancy or lactation during the study
- •Abnormal nasolacrimal drainage (by history)
- •Punctal cauterization or punctal plug placement within 60 days of screening
- •Prohibited Medications - Cyclosporine (Restasis®); any topical prescription medications (i.e., steroids, NSAIDs, etc); glaucoma medications; oral tetracyclines or topical macrolides; oral nutraceuticals (flax, black currant seed oils, etc...) within 3 weeks (21 days) of Screening and at any time during the study
结局指标
主要结局
Tear Osmolarity
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
研究点 (2)
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