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临床试验/NCT03417505
NCT03417505已完成不适用

Tangible Hydra-PEG: A Promising Solution for Scleral Lens Wearers With Dry Eye

Tangible Science6 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2018年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
21
试验地点
6
主要终点
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)

研究概览

简要总结

Tangible Hydra-PEG is a novel coating technology designed to improve lens wettability, deposit resistance, and tear film breakup time. This is a randomized double masked cross-over study to examine contact lens discomfort and dry eye symptoms with Tangible Hydra-PEG treated scleral lens wear compared to untreated scleral lens wear in the dry eye patient population.

详细描述

Dry eye (DE) is a common complaint of millions of people worldwide with a significant impact on quality of life. For decades, this condition has presented a challenge to eye care professionals as conventional therapies are often ineffective. Recently, scleral lenses have demonstrated to be a promising therapeutic and vision rehabilitative option for dry eye sufferers. Nonetheless, despite the benefits of scleral lenses for dry eye patients, inadequate wettability of scleral lenses with subsequent diminished comfort and visual clarity remains a concern for scleral lens wearers with dry eye.

Tangible Hydra-PEG (Tangible Science LLC, Menlo Park, CA, USA) is a novel coating technology designed to improve lens wettability, deposit resistance, and tear film breakup time, ultimately enhancing contact lens comfort. While studies have shown that Tangible Hydra-PEG technology can improve contact lens discomfort (CLD) in soft contact lens and gas permeable lens wearers, to our knowledge, no clinical research investigation has examined the benefits of this new coating on scleral lens wear in dry eye sufferers. As such, the aim of this study is to compare the CLD and DE symptoms of dry eye scleral lens wearers between Tangible Hydra-PEG treated scleral lens wear and untreated scleral lens wear. CLD and DE signs will also be assessed to corroborate our findings.

This will be the first randomized double masked cross-over study to examine CLD and DE symptoms of Tangible Hydra-PEG treated scleral lens wear compared to untreated scleral lens wear in the dry eye patient population. Tangible Hydra-PEG treated scleral lenses can potentially minimize CLD and DE symptoms, ultimately improving outcomes for patients coping with dry eye disease. This study will provide new information about this innovative technology and help practitioners envisage rehabilitative options which will best optimize the quality of life of this important patient population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Reduced tear film break up time (TBUT), a sign of dry eye disease and contact lens discomfort
  • Scleral lens wearer (at least 8 hours per day for at least 5 days per week and have had their habitual lenses no longer than 1 year). Scleral lenses wear will be defined as 15.00 mm to 19.00 mm inclusive.

排除标准

  • Disorders that affect sensitivity (herpetic disease, severe diabetes mellitus)
  • Anatomic variations of the conjunctiva that can impair proper scleral lens fitting
  • Pregnancy
  • Best corrected Snellen visual acuity worse than 20/30 in either eye
  • Ocular pathology other than dry eye (e.g. glaucoma, macular degeneration, keratoconus) which may significantly impact visual function.

结局指标

主要结局

Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)

时间窗: 30 days

Validated dry eye questionnaire to assess symptoms after wearing Hydra-PEG treated lenses compared to control lenses. Scale is from 1 to 37, with higher scores indicating more dry eye symptoms.

Ocular Surface Tear Breakup Time

时间窗: 30 days

Tear breakup time of the ocular surface after wearing lenses

Corneal Fluorescein Staining

时间窗: 30 days

Fluorescein staining followed by assessment using the Oxford grading scale (0-5, where 5 indicates the most staining and therefore the most damage to the ocular surface) of the ocular surface after wearing Hydra-PEG treated lenses compared to control lenses

Ocular Surface Disease Index (OSDI) Questionnaire

时间窗: 30 days

Dry eye questionnaire to assess symptoms after wearing Hydra-PEG treated lenses compared to control lenses. Patients will be scored from 0 (no dry eye disease) to 100 (severe dry eye disease).

次要结局

  • Nasal Conjunctival Lissamine Green Staining(30 days)
  • Tear Breakup Time Over the Surface of the Scleral Lens(30 days)
  • Lid Wiper Epitheliopathy(30 days)
  • Contact Lens-related Papillary Conjunctivitis(30 days)
  • Temporal Conjunctival Lissamine Green Staining(30 days)

研究者

发起方
Tangible Science
申办方类型
Industry
责任方
Sponsor

研究点 (6)

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