Dry Eye OmniLenz Application of Omnigen Research Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Symptoms
研究概览
简要总结
Dry eye disease (DED) is a disease of the ocular surface characterised by ocular surface inflammation and damage and neurosensory abnormalities. Tear film breakup leading to localised hyperosmolarity can result in ocular surface damage either directly or through the cascade of inflammation that it initiates. Transplantation of human amniotic membrane has been used for many ophthalmic indications including many related to inflammation of the ocular surface.
A recent study published by McDonald and colleagues in 2018 conducted in 84 DED patients (97 eyes) receiving cryopreserved AM treatment (Prokera) in addition to prior maximal medical management demonstrated an improved ocular surface along with a notable reduction in disease severity scores.
Omnigen is a dehydrated amniotic membrane derived from human sources and certified by the UK Human Tissue Authority. OmniLenz Bandage Contact Lens (BCL) is a bespoke bandage contact lens (BCL) designed to enable the application of Omnigen without the need for either sutures or glue. The application procedure takes approximately 15 minutes and the patients wear the lens continually. The McDonald study indicates that any improvement seen persists for at least three months.
This study aims to expand on the work by McDonald et al. The study will be a randomised, parallel group study comparing Omnigen treatment applied with an OmniLenz BCL to OmniLenz BCL alone. The later treatment enables a degree of masking and for any difference to be attributable to the Omnigen rather than a contact lens. This is in line with the recommendations laid out be the DEWS group. Interim data and analysis will be conducted after enrolment of 20 patients. Following the first week application the eye will be assessed, and a further treatment applied for a further week. Therefore, the total treatment period will be two weeks with follow-up assessments at one and three months. At six months patients will complete an OSDI and EQ-5D assessment via email or post. The primary efficacy variability will be change in OSDI score, a patient reported scoring of dry eye symptoms. A number of clinical assessments of the ocular surface will also be performed as part of the secondary outcomes whilst the opportunity to measure a number of exploratory measures will enable further work following this study.
详细描述
The TFOS DEWS II report redefines dry eye as:
". . . a multifactorial disease of the ocular surface characterised by a loss of homeostasis of the tear film, and accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles." Dry eye disease (DED) is a global problem, afflicting at least 344 million people worldwide, and is one of the most frequent causes of patient visits to eye care practitioners. However, the epidemiology of DED continues to be a challenge due to the lack of a standardised worldwide definition. The prevalence of DED, with and without symptoms, ranges from 5 to 50%.
Tear hyperosmolarity, as well as inflammatory mediators, may induce DED symptoms and cause damage to epithelial cells, surface microvilli, barrier function, the glycocalyx, and goblet cells. Epithelial cell damage, lipid layer and blinking abnormalities, defective glycocalyx, loss of gel mucin and reduction in tear volume may result in loss of lubrication between the globe and eyelids, resulting in increased friction and also symptoms.
Inflammation of the ocular surface can cause inhibition of lacrimal secretion and loss of epithelial barrier function at the ocular surface. Tear film breakup, leading to localised hyperosmolarity, can result in ocular surface damage either directly or through the cascade of inflammation that it initiates. Improved understanding of the role of subclinical inflammation in the early stages of DED also warrants further study.
Amniotic membrane (AM) has been utilised for many years as an adjuvant for tissue healing, with the first recorded use by Davis in 1910 during skin transplantation and in the 1930s by Sorsby for chemical injuries to the eye. Transplantation of human amniotic membrane has since been used for many ophthalmic indications. Reports describe its efficacy in reconstructing a corneal surface severely damaged by chemical agents, promoting the healing of persistent corneal epithelial defects, enhancing the success of corneal surface reconstruction surgery and substituting for conjunctival autografts after excision of pterygium or removal of conjunctival lesions.
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
- Double (Participant, Investigator)
盲法说明
Patient will not be aware whether bandage contact lens has an amniotic membrane beneath in periphery or not Masked investigator will perform the clinical examinations
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
- •A mean average score of 25 to 80 using more than one OSDI assessment in the last six weeks
- •DED present for at least 12 months
- •Informed consent
- •Aged 18 or over on date of Baseline assessment
- •Able to Attend Aston University
- •No changes to current DED therapy in the last six weeks
- •Presence of at least 1 of the following signs in the same eye at baseline visits
- •Corneal (≥5 punctate spots)
- •Conjunctival (≥9 punctate spots) staining present (Oxford scale)
- •Tear film break-up time (TBUT) less than or equal to 8 seconds
- •Received study information and expressed willingness to take part in this study
- •Confirmed able to attend the assessment visits described in the patient information
- •Able and willing to complete the patient information diaries
排除标准
- •Taking medication (except dry eye treatments) that is known to affect the tear film
- •Currently using moisture chamber or goggles
- •Active ocular surface pathology other than dry eye
- •Ocular topography that in the clinician opinion would make OmniLenz BCL treatment inappropriate
- •Allergic to ingredients within Omnigen (i.e. the antibiotics)
- •History of:
- •Ocular herpetic keratitis
- •Ocular surgery in past 6 months
- •Use of glaucoma medicine
- •Surgery for glaucoma
- •Eyelid abnormalities or extensive ocular scarring
研究组 & 干预措施
OmniLenz
Bandage contact lens alone
干预措施: Bandage soft Contact Lens OmniLenz[R] (Device)
Omnigen + OmniLenz
Omnigen amniotic membrane 17mm disk with 6mm central aperture place under 18mm OmniLenz bandage contact lens
干预措施: Amniotic membrane Omnigen[TM] (Device)
Omnigen + OmniLenz
Omnigen amniotic membrane 17mm disk with 6mm central aperture place under 18mm OmniLenz bandage contact lens
干预措施: Bandage soft Contact Lens OmniLenz[R] (Device)
结局指标
主要结局
Symptoms
时间窗: 12 weeks post baseline
Symptoms assessed with the Ocular Surface Disease Index questionnaire \[0-100 range, higher worse\]
次要结局
- Change in ocular redness over time(2, 4, and 12 weeks post baseline)
- Change in tear meniscus height over time(2, 4, and 12 weeks post baseline)
- Change in Symptoms over time(2, 4,12 and 24 weeks post baseline)
- Change in visual acuity over time(2, 4, and 12 weeks post baseline)
- Health Utility(24 weeks compared to baseline)
- Change in ocular surface staining over time(2, 4, and 12 weeks post baseline)
- Change in non-invasive tear breakup time over time(2, 4, and 12 weeks post baseline)
研究者
James Wolffsohn
Professor of Optometry
Aston University