NCT05949697已完成不适用
A Prospective Study of the Dry Eye Drink by Bruder Healthcare That Evaluates Hydration and Subject's Assessment on Eye Dryness
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change on the SPEED score
研究概览
简要总结
A study to assess the effect of the Dry Eye Drink on eye dryness
详细描述
This is a prospective, non-randomized, comparative study of the Dry Eye Drink by Bruder Healthcare that evaluates hydration and subject's assessment on eye dryness. Subjects will administer the Dry Eye Drink by adding one sachet of the Dry Eye Drink powder in 12 Oz of water.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and/or female subjects aged between 18 and 65 years (both limits inclusive).
- •Subjects with symptomatic Dry Eye Syndrome confirmed at baseline in at least any one or both the eyes.
- •Subjects with ≥ 310 mOsmol/L tear osmolarity.
- •Subjects with ≥ 6 SPEED score.
- •Subject willing to provide written informed consent and able to comply with protocol requirements.
排除标准
- •Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
- •Have undergone mechanical treatment for meibomian gland dysfunction using thermal pulsation/expression (e.g., LipiFlow) or intense pulsed light (e.g., OptiLight) therapy within 6 months prior to the Screening/Baseline Visit
- •Have a known hypersensitivity to any of the study product components
- •Have undergone ocular surgery (e.g., cataract, corneal or refractive surgical procedure) within 6 months prior to the Screening/Baseline Visit
- •Have evidence of clinically significant ocular trauma
- •Have active ocular Herpes simplex or Herpes Zoster infection
- •Have ocular inflammation (uveitis, iritis, scleritis, episcleritis, conjunctivitis or keratitis, with the exception of keratoconjunctivitis sicca) at the discretion of the investigator
- •Have ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids. including hordeolum)
- •Have severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis)
- •Have eyelid abnormalities that significantly affect the lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis)
- •Have an ocular surface abnormality that may compromise the corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal dystrophy, or the effect of any other ophthalmic medication that might in the opinion of the investigator compromise the ocular surface integrity)
- •Have a systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study or with the lengthier assessments required by the study (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction or heart disease, etc.)
- •Participation in any clinical study within 30 days before the first administration of study product.
- •Subjects who are illiterate and cannot complete the subject diary independently.
结局指标
主要结局
Change on the SPEED score
时间窗: Day 0 and Day 30
Change on the subjects' perception of eye dryness from Baseline to end of treatment as assessed by Standard Patient Evaluation of Eye Dryness (SPEED) score
次要结局
- Change in MMP-9 levels(Day 0 and Day 30)
- Change in Tear Osmolarity(Day 0 and Day 30)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
不适用
Observational Study on the Improvement of Dry Eye Syndrome, Treatment Satisfaction, and Intraocular Tolerance With Diquasol Eye DropsDry Eye SyndromeNCT06172530Hanlim Pharm. Co., Ltd.2,000
招募中
不适用
The pilot study of Eye and surround the eye nerve stimulation after LASEK(Laser Asisted Sub-Epithelial Keratomileusis) with dry eye.KCT0004602u Eyne24
已完成
不适用
Clinical Trial to Assess the Effectiveness of I+Med's DayDrop Advanced Ophthalmic DropDry Eye SyndromeNCT06732830i+Med S.Coop.45
已完成
4 期
Effects of Dry Eye Treatments on the Ocular SurfaceKeratoconjunctivitis SiccaDry Eye SyndromeNCT01797822Baylor College of Medicine20
尚未招募
不适用
The research for the relationship between dry eye with corneal neuropathic pain and galectin-3 concentration in teardry eye diseaseJPRN-UMIN000040952Keio University60