Umbilical Cord Serum Versus Conventional Eyedrops In Treatment of Moderate To Severe Dry Eye Disease: A Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 102
- 试验地点
- 3
- 主要终点
- Comparison of dry eye symptom improvements in patients treated with Umbilical Cord Serum eyedrops and conventional AT eyedrops
研究概览
简要总结
Dry eye disease (DED) is a chronic ocular surface disease and the prevalence of DED has been reported as high as 50%. Recently, The international Dry Eyes Workshop II (DEWS II) defines dry eye as a "multifactorial disease of the ocular surface characterized 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". A study done by Yoon et al. on 31 patients with severe DED concluded that UCS eye drops are effective and safe in treating severe DED. Studies found that EGF, TGF-β, VEGF and vitamin A levels were significantly higher in UCS than peripheral blood serum(PBS) whereas IGF content was significantly higher in PBS than in CBS. Yoon et al. then conducted another study whereby he compared UCS to AS in treating both Sjögren syndrome and non- Sjögren syndrome patients with severe dry eyes. They concluded that UCS eye drops were more effective in decreasing symptoms and keratoepitheliopathy in severe dry eye syndrome and increasing goblet cell density in Sjögren syndrome compared with AS drops. Despite proven more effective in treating DED, serum eye drops are not yet widely manufactured due to a few reasons. This study is chosen because
- Not many previous clinical trials done related to UCS eye drops.
- There were only two clinical trials done before to compare the use of UCS eye drops versus conventional AT eye drops on Hansen's disease and acute ocular chemical burn injury population.
- To apply the newer technology of Keratograph® 5M in DED assessment.
- To initiate a proper standard operating procedure for production as well as delivery of serum eye drops which allowing out-patient treatment with serum eye drops possible.
详细描述
This is a prospective, single- blinded randomized clinical trial conducted in University Kebangsaan Malaysia Medical Centre (UKMMC). Umbilical cord serum will be provided by Pusat Darah Negara (National Blood Centre), Malaysia. All patients from Ophthalmology Clinic in UKM Medical Centre from December 2019 till December 2021 will be involved in this study. Patients who fulfill the inclusion criteria will be included in this study. Informed consent will be taken and dry eye assessment that includes visual acuity, OSDI score, Schirmer test, NITBUT, corneal fluorescein staining, TMH and conjunctival injection. The patients will be randomised into 2 groups; AT eye drops and UCS eye drops.
Human umbilical cord blood samples will be collected from Maternity Hospital, Hospital Kuala Lumpur with assistance of the nurses from Cord Blood Collection Unit. All maternal blood samples were collected after the written informed consent from respective parents and subjected for virology screening.
National Blood Bank has a procedure for virology screening and all collected maternal umbilical cord bloods will be screened for Hep B Surface Antigen, Anti-HCV Ag/Ab, HIV Ag/Ab, Syphillis and Cytomegalovirus (CMV) IgM in Transfusion Microbiology Laborator (Accredited by ISO 15189 and CSL). Method that has been used in the screening as below:
- Hep B Surface Antigen, Anti-HCV, HIV Ag/Ab: Chemiluminescent Microparticle Immunoassay (CMIA).
- Syphilis : Carbon Antigen (Manual)
- CMV IgM : Electrochemiluminescence Immunoassay (ECLIA)
Whereas, the CB samples are screened for bacteriology screening pre and post processing to ensure sterility of the product. The serum will be discarded if any of the laboratory results are positive or reactive.
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, Care Provider)
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
- •Moderate to severe Dry Eye Disease based on OSDI score or DED severity grading scheme
- •Patients willing to participate in this study and able to provide consent
- •Patients with domestic freezer at home
排除标准
- •Infective cases
- •Cases with limbal stem cells deficiency
- •Patients with lid abnormalities
- •Allergic to study eye drops component
研究组 & 干预措施
A-AT eye drops
Optive Fusion UD eye drops + Genteal lubricant gel
干预措施: Optive, Ophthalmic Solution (Drug)
A-AT eye drops
Optive Fusion UD eye drops + Genteal lubricant gel
干预措施: Genteal lubricant gel (Drug)
B-UCS eye drops
UCS eye drops + GentTeal lubricant gel
干预措施: Umbilical Cord Serum eye drops (Biological)
B-UCS eye drops
UCS eye drops + GentTeal lubricant gel
干预措施: Genteal lubricant gel (Drug)
结局指标
主要结局
Comparison of dry eye symptom improvements in patients treated with Umbilical Cord Serum eyedrops and conventional AT eyedrops
时间窗: At 8th week of treatment
Change of dry eye symptoms from baseline based on Ocular Surface Disease Index (OSDI) score at 8th week of eyedrop instillation.
Comparison of change in corneal surface in patients treated with Umbilical Cord Serum eyedrops and conventional AT eyedrops
时间窗: At 8th week of treatment
Change of non-invasive tear break-up time (s) and Tear Break-up Time (s) of corneal surface from Baseline by using Oculus Keratograph-5 Machine at 8th week of eyedrop instillation.
Comparison of meniscometry (mm) in patients treated with Umbilical Cord Serum eyedrops and conventional AT eyedrops
时间窗: At 8th week of treatment
Change in tear meniscus height (mm) of corneal surface from Baseline by using Oculus Keratograph-5 Machine at 8th week of eyedrop instillation.
Comparison of change in corneal surface signs in patients treated with Umbilical Cord Serum eyedrops and conventional AT eyedrops
时间窗: At 8th week of treatment
Change of Corneal surface signs (ie punctate epithelial erosions) from Baseline based on Oxford Scale Eye Grading through slit-lamp examination at 8th week of eyedrop instillation. The grade ranges from 0-5, in which higher scores indicate worse outcome.
Comparison of ocular surface redness in patients treated with Umbilical Cord Serum eyedrops and conventional AT eyedrops
时间窗: At 8th week of treatment
Change of ocular surface redness from Baseline based on Redness Scoring using Oculus Keratograph-5 Machine at 8th week of eyedrop instillation.
Comparison of change in basal tear production in patients treated with Umbilical Cord Serum eyedrops and conventional AT eyedrops
时间窗: At 8th week of treatment
Change of basal tear production (mm) from Baseline through Schirmer's test at 8th week of eyedrop instillation.
次要结局
未报告次要终点
研究者
Wan Haslina Wan Abdul Halim
Consultant Ophthalmologist-Cornea And Anterior Segment
National University of Malaysia