The Protective Impact of TheaLoz Duo Eyedrop on the Ocular Surface in Hand-Held Console and Computer Game Users
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change from First Follow-Up in Ocular Surface Disease Index scores to the Second Follow-Up 1 Month After the First Follow-Up
研究概览
简要总结
The excessive use of screens particularly amongst digital gamers can adversely impact the health of the surface of the eyes with symptoms and signs of surface damage. While strategies including limiting screen time exist, these may be ineffective given the widespread rise of digital device use and gaming culture in the modern era. There is limited evidence for the protective effect of lubricating eyedrops on the ocular surface for handheld console and computer gamers.
The aim of this study is to investigate the protective effect of a lubricating eyedrop (TheaLoz Duo) on the surface of the eyes in handheld console and computer gamers. The main question it aims to answer is whether TheaLoz Duo could protect the surface of the eyes from dessication and alleviate symptoms of dry eye disease in handheld console and computer gamers.
Participants will receive either the lubricating eyedrop first for 1 month, followed by a control condition (no eyedrops) for another month, or the other way round. Participants will attend 3 visits in total, each separated by 1 month apart. During each visit, routine clinical assessments of the front of the eye will be conducted. Subsequent findings from this timely study will help improve care of the surface of the eyes for a growing population of gamers worldwide.
详细描述
This study will be a randomized, outcome assessor-masked, cross-over clinical study to assess the potential impact of TheaLoz Duo lubricating eyedrop on symptoms and signs of dry eye disease in handheld console and computer gamers. All visits will be conducted at the Aston Dry Eye Clinic in Aston University, Birmingham, United Kingdom.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Individuals with dryness symptoms as assessed with the Ocular Surface Disease Index (OSDI score ≥ 13).
- •Individuals who play handheld console and computer-based games ≥ 2 hours everyday on average
- •Individuals who are comfortable and competent at using smartphone applications
- •Age ≥ 18 years, male or female
- •Able to provide written consent in English
- •Able to instil the treatment lubricating eyedrop on their own, and return any provided eyedrop bottle to the researcher used at the end of the treatment
- •Able to attend multiple visits (3 visits over 2 months)
排除标准
- •Pregnancy
- •Use of any topical ocular medical eyedrops or lubricants in the 1 week prior to starting the study or during the study period. Those who are using existing lubricating eyedrops and are interested in participating will be required to stop their lubricating eyedrops for 1 week prior to commencing the study
- •History of ocular surgery, trauma or infections in the past 6 months
研究组 & 干预措施
TheaLoz Duo in first month, crossover to control condition in second month
The TheaLoz Duo eyedrop will be prescribed and used by the participant for 1 month. At the second visit 1 month later, the participant will return the TheaLoz Duo eyedrop bottle, and no eyedrops will be prescribed, and the participant monitored following 1 month. At the third and final visit 1 month later, the participant will return for a follow-up visit.
干预措施: TheaLoz Duo Eyedrop (Drug)
Control condition in first month, crossover to TheaLoz Duo in second month
No eyedrops will be prescribed and the participant monitored for 1 month. At the second visit 1 month later, the participant will return and be prescribed TheaLoz Duo eyedrop and used by the participant for another 1 month. At the third and final visit 1 month later, the participant will return the TheaLoz Duo eyedrop bottle and complete the study visits.
干预措施: TheaLoz Duo Eyedrop (Drug)
结局指标
主要结局
Change from First Follow-Up in Ocular Surface Disease Index scores to the Second Follow-Up 1 Month After the First Follow-Up
时间窗: First follow-up to 1 month after the first follow-up
Validated questionnaire for assessing dry eye symptom severity and impact. Scores range from 0 indicating no dry eye symptoms to 100 with severe dry eye symptoms and impact (Schiffman et al, 2000).
Change from Baseline in Ocular Surface Disease Index scores to the First Follow-Up 1 Month After Baseline
时间窗: Baseline to 1 month after baseline
Validated questionnaire for assessing dry eye symptom severity and impact. Scores range from 0 indicating no dry eye symptoms to 100 with severe dry eye symptoms and impact (Schiffman et al, 2000).
次要结局
- Change from First Follow-Up in Lipid Layer Pattern to the Second Follow-Up 1 Month After the First Follow-Up(First follow-up to 1 month after the first follow-up)
- Change from First Follow-Up in Blink Rate to the Second Follow-Up 1 Month After the First Follow-Up(First follow-up to 1 month after the first follow-up)
- Change from Baseline in Fluorescein Corneal Staining to the First Follow-Up 1 Month After Baseline(Baseline to 1 month after baseline)
- Change from Baseline in Lissamine Green Bulbar Conjunctival Staining to the First Follow-Up 1 Month After Baseline(Baseline to 1 month after baseline)
- Change from Baseline in Computer Vision Syndrome Questionnaire scores to the First Follow-Up 1 Month After Baseline(Baseline to 1 month after baseline)
- Change from First Follow-Up in Computer Vision Syndrome Questionnaire scores to the Second Follow-Up 1 Month After the First Follow-Up(First follow-up to 1 month after the first follow-up)
- Change from Baseline in Visual Acuity to the First Follow-Up 1 Month After Baseline(Baseline to 1 month after baseline)
- Change from First Follow-Up in Visual Acuity to the Second Follow-Up 1 Month After the First Follow-Up(First follow-up to 1 month after the first follow-up)
- Change from First Follow-Up in Tear Meniscus Height to the Second Follow-Up 1 Month After the First Follow-Up(First follow-up to 1 month after the first follow-up)
- Change from Baseline in Tear Meniscus Height to the First Follow-Up 1 Month After Baseline(Baseline to 1 month after baseline)
- Change from Baseline in Bulbar Conjunctival Hyperaemia to the First Follow-Up 1 Month After Baseline(Baseline to 1 month after baseline)
- Change from First Follow-Up in Bulbar Conjunctival Hyperaemia to the Second Follow-Up 1 Month After the First Follow-Up(First follow-up to 1 month after the first follow-up)
- Change from First Follow-Up in Fluorescein Corneal Staining to the Second Follow-Up 1 Month After the First Follow-Up(First follow-up to 1 month after the first follow-up)
- Change from Baseline in Meibography Meiboscore to the First Follow-Up 1 Month After Baseline(Baseline to 1 month after baseline)
- Change from First Follow-Up in Meibography Meiboscore to the Second Follow-Up 1 Month After the First Follow-Up(First follow-up to 1 month after the first follow-up)
- Change from Baseline in Lipid Layer Pattern to the First Follow-Up 1 Month After Baseline(Baseline to 1 month after baseline)
- Change from First Follow-Up in Lissamine Green Bulbar Conjunctival Staining to the Second Follow-Up 1 Month After the First Follow-Up(First follow-up to 1 month after the first follow-up)
- Change from Baseline in Blink Rate to the First Follow-Up 1 Month After Baseline(Baseline to 1 month after baseline)
- Number of Participants with Dry Eye Disease at SecondFollow-Up(At second follow-up 1 month after first follow-up)
- Number of Participants with Dry Eye Disease at Baseline(At baseline)
- Change from Baseline in Lissamine Green Lid Wiper Epitheliopathy to the First Follow-Up 1 Month After Baseline(Baseline to 1 month after baseline)
- Change from First Follow-Up in Lissamine Green Lid Wiper Epitheliopathy to the Second Follow-Up 1 Month After the First Follow-Up(First follow-up to 1 month after the first follow-up)
- Number of Participants with Dry Eye Disease at First Follow-Up(At first follow-up 1 month after baseline)
研究者
Jeremy Chiang
Postdoctoral Research Associate
Aston University