An Evaluation of Tangible Boost Replenishing System for Patients With Stevens Johnson Syndrome, Sjogren's Syndrome, and Graft Versus Host Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Tear break up time
研究概览
简要总结
The goal of this research is to determine if the Tangible Boost system adequately replenishes the Hydra-PEG coating on the surface of a rigid contact lens.
Hydra-PEG is a coating for soft and rigid contact lens, primarily composed of polyethylene glycol-based hydrogel, which is covalently bound to the surface of a contact lens. The Hydra-PEG coating is intended to improve wettability and comfort with contact lenses and is currently FDA approved on a number of contact lenses. For patients with Stevens Johnson Syndrome (SJS) (SS), or Graft versus Host disease (GVHD), diminished efficacy of the Hydra-PEG coating can lead to significant decline in satisfaction with the lenses over time. This is a prospective study to evaluate the efficacy of Tangible Boost, a monthly conditioning solution, to replenish the Hydra-PEG coating on rigid gas permeable contact lenses for patients with SJS, GVHD, and SS. Outcomes from this patient population will be compared to patients with dry eye disease.
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)
盲法说明
Test and placebo treatment kits will be randomized by the sponsor prior to sending to clinical site.
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
- •Written Informed Consent has been obtained prior to any study-related procedures taking place
- •Written documentation has been obtained in accordance with the relevant county and local privacy requirements, where applicable
- •Male or female
- •18 years of age and older prior to the initial visit
- •Is a new or established wearer of PROSE lenses with optimized lens fit prior to enrollment in the study
- •Has been diagnosed with Dry Eye Syndrome, SJS, SS, or GVHD
- •In the opinion of the investigator, the subject has the ability to follow study instructions
- •In the opinion of the investigator, the subject has the ability to complete all study procedures and visits
排除标准
- •aphakic (i.e., missing their natural lens inside the eye)
- •Is currently participating in any other type of eye-related clinical or research study
- •Is pregnant or nursing as reported by the subject
- •Has a condition or is in a situation which, in the investigator's opinion, may put the subject at significant risk, may confound study outcomes, or may significantly interfere with the subject's participation in the study.
- •Has a known and self-reported allergy to the following substances: polyethylene glycol, polyvinyl alcohol, triethanolamine, polyquaternium-1, or edetate disodium, which are components of the Tangible Boost and Hydra-PEG systems or care regimen.
- •Has had previous ocular surgery within the past 12 weeks
- •Adults unable to consent (including adults unable to read and understand English)
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women
- •Prisoners
- •Employees of BostonSight
结局指标
主要结局
Tear break up time
时间窗: 6 months
Seconds required for tear film to begin to break up
Visual Acuity
时间窗: 6 months
Snellan visual acuity
Ocular Surface Staining
时间窗: 6 months
Sodium fluorescein staining will be used to evaluate ocular surface damage indicated by cell damage or death. Corneal staining will be scored using the Oxford grading scale.
Contact Lens Comfort
时间窗: 6 months
OSDI plus additional specific questions
次要结局
- Contact lens fit characteristics(6 months)