A Single Center, Open-Label Study to Evaluate the Ability of the TearScience™ LipiView™ II Ocular Surface Interferometer and the Keratograph® 5M to Detect Tear Film Stability Utilizing Miebo®
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Assess the effect of Miebo® on the TearScience™ LipiView™ II Ocular Surface Interferometer Lipid Layer Thickness (LLT) Evaluation
研究概览
简要总结
A study to investigate the ability of the TearScience™ LipiView™ II Ocular Surface Interferometer and the Keratograph® 5M to detect tear film stability utilizing Miebo®
详细描述
Determine the ability of the TearScience™ LipiView™ II Ocular Surface Interferometer and the Keratograph® 5M to detect tear film stability utilizing Miebo® by examining potential differences in various tear film assessments before dosing Miebo® and at multiple timepoints post-Miebo® dosing
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •At least 18 years of age at the time of consent
- •Able to provide written voluntary informed consent
- •Must have a normal pre-corneal tear film in one or both eyes[MC4.1][AA4.2]
- •Subjects cannot have instilled any topical ocular drops (including OTC lubricant drops) within 24 hours of the study visit.
- •Able and willing to follow instructions, including participation in all trial assessments and visits
排除标准
- •Have any clinically significant ocular surface slit-lamp findings in either eye and/or, in the opinion of the Investigator, have any findings that could interfere with trial parameters including:
- •History of Stevens-Johnson syndrome
- •Active blepharitis or lid margin inflammation
- •DED secondary to scarring, irradiation, alkali burns, cicatricial pemphigoid, or destruction of conjunctival goblet cells (as with vitamin A deficiency)
- •Abnormal lid anatomy causing incomplete eyelid closure
- •Abnormal cornea shape (keratoconus)
- •Corneal epithelial defect or significant confluent staining or filaments
- •History of ocular malignancy
- •Pterygium in either eye
- •Use of any of the following ocular therapies in the study eye within 24 hours prior to Visit 1: Vuity®, VIZZ™, topical ocular steroid treatments, topical antibiotics, prescription dry eye therapy including varenicline nasal spray, over the counter dry eye therapy (such as artificial tears, re-wetting drops, or Lumify®), TrueTear™ device (intranasal tear neurostimulator), or topical anti-glaucoma medication
- •Have active uncontrolled ocular allergies or ocular allergies that are expected to be active during the trial period
- •Have undergone intraocular surgery or ocular laser surgery in the study eye within 3 months prior to Visit 1; have undergone refractive surgery in the study eye within 6 months prior to Visit 1
- •Have worn contact lenses within 24 hours prior to Visit
- •Have active ocular or systemic infection (bacterial, viral, or fungal), including fever
- •Female subjects who are pregnant, nursing, or planning a pregnancy
- •Female subjects of childbearing potential who are not using an acceptable means of birth control; acceptable methods of contraception include hormonal (oral, implantable, injectable, or transdermal) contraception; mechanical (spermicide in conjunction with a barrier such as a diaphragm or condom) contraception; intrauterine device; or surgical sterilization of partner. For non-sexually active female subjects, abstinence may be regarded as an adequate method of birth control; however, if the subject becomes sexually active during the trial, she must agree to use adequate birth control as defined above for the remainder of the trial
- •Have an uncontrolled systemic disease that, in the opinion of the Investigator, will interfere with the trial
- •Have a known allergy and/or sensitivity to the investigational product or diagnostic substances (e.g. fluorescein) to be used in the study
- •Are currently enrolled in any investigational or device study or have used Miebo® within 24 hours prior to Visit
研究组 & 干预措施
Determine the ability of the TearScience™ LipiView™ II Ocular Surface Interferometer and the Keratog
Determine the ability of the TearScience™ LipiView™ II Ocular Surface Interferometer and the Keratograph® 5M to detect tear film stability utilizing Miebo® by examining potential differences in various tear film assessments before dosing Miebo® and at multiple timepoints post-Miebo® dosing
干预措施: Determine the ability of the TearScience™ LipiView™ II Ocular Surface Interferometer and the Keratograph® 5M to detect tear film stability utilizing Miebo® (Drug)
结局指标
主要结局
Assess the effect of Miebo® on the TearScience™ LipiView™ II Ocular Surface Interferometer Lipid Layer Thickness (LLT) Evaluation
时间窗: 1 hour
Number of subjects with an increase from baseline in lipid layer thickness as assessed by the TearScience™ LipiView™ II Ocular Surface Interferometer
次要结局
未报告次要终点