Safety and Efficacy of Heated Artificial Tears Under Practical Conditions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Non-invasive tear break-up time (NIBUT)
研究概览
简要总结
Ocular surface temperature of a normal person is around 34.6 degree centigrade. After instilling the eye drop, depending on the temperature of the eye drop and the ocular surface, the ocular surface temperature will temporally increase or decrease sightly. Warm feeling will make blood vessels dilated and more blood will pass through to bring more blood flow out of our body to the heated area of the body and makes cells more permeable. Therefore, heating the ocular surface with heated eye mask after instilling artificial tears has the possibility to improve drug permeability on the ocular surface.
详细描述
Evaporative dry eye (EDE) is common and can lead to ocular pain, decreased visual quality, and reduced quality of life. 3% diquafosol (DQS) ophthalmic solution and heated eye mask (HEM) have been found to be beneficial in reducing signs and symptoms of dry eye. Warm compress therapy temperature of 40 °C to 45 °C have been typically advocated to melt the meibium causing obstruction at the orifices of the meibomian gland, eventually allowing increased lipid layer of the tear film. While in impact of heat on the ocular surface (OS) has not been extensively studied. Controlled and precise application of heat has the ability to create a cascade of events in the skin and thus aids in facilitating a faster movement of molecules into and across the skin. Possible mechanisms of enhancing drug permeation include on the ocular surface could be: (mechanisms may operate individually or concurrently):
- increase in drug diffusivity in the vehicle and/or in the ocular surface
- increase in partitioning and diffusion
- alteration in the lipid structure
- increased local blood flow Therefore, the purpose of this RCT is to assess the impact of instilling 3% DQS ophthalmic solution follow by HEM raising the OS temperature by 40 degrees centigrade for 10 minutes.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Masked examiner for all clinical assessments will not involved in the data collection or group allocation procedure for this research. The investigator will not be aware of the three groups.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •The presence of at most one symptom including burning, foreign body sensation, itching or eye fatigue for 3 months
- •OSDI score ≥ 13 and TBUT <5 s or NIBUT < 10s
- •Able and willing to comply with the treatment/follow-up schedule
排除标准
- •A recent history (past 30 days) of topical ophthalmic medication use, including antibiotics, steroids, non-steroidal anti-inflammatory drugs, or required the chronic use of topical ophthalmic medications
- •Eyelids or intraocular tumors that should not put pressure
- •Active allergy or infection or inflammatory disease that may have prevented the subjects from completing the study at the ocular surface
- •Any structural change in lacrimal passage
- •Diabetes or other systemic, dermatologic, or neurologic diseases that affect the health of ocular surface
- •Use of any systemic anti-inflammatory drugs or medication that may interfere with tear production, such as antianxiety, antidepressive, and antihistamine medications within 3 months
研究组 & 干预措施
DQS+HEM
Participants in the DQS+ group used DQS 1 drop 3 times/per day with heated eye mask for 2 weeks
干预措施: Diquafosol tetrasodium (Drug)
DQS+HEM
Participants in the DQS+ group used DQS 1 drop 3 times/per day with heated eye mask for 2 weeks
干预措施: Heated eye mask (Device)
DQS
Participants in the DQS group used DQS 1 drop 3 times/per day for 2 weeks
干预措施: Diquafosol tetrasodium (Drug)
HEM
Participants in the HEM group used heated eye mask 3 times/per day for 2 weeks
干预措施: Heated eye mask (Device)
结局指标
主要结局
Non-invasive tear break-up time (NIBUT)
时间窗: Day-0 (baseline), day-7, and day-14
Non-invasive initial tear film breaking time will be assessed using the Keratograph 5M (Oculus, Germany) topographer. Three sequentially readings will be captured, and the median value will be included in the final analysis. The median value will be recorded. * Changes at day-14 and day-28 will be compare with baseline measurements. * Comparison between groups at baseline, day-14 and day-28 will also be examined.
Ocular Surface Disease Index (OSDI)
时间窗: Day-0 (baseline), day-7, and day-14
OSDI, which is a questionnaire consisting of 12 questions for evaluating the effects of dry eye syndrome on vision, ocular symptoms and any condition associated with DED. The patient will answer each question on a scale ranging from 0 to 4, with 0 indicating 'none of the time' and 4 indicating 'all of the time'. If a certain question is deemed irrelevant, it will be marked as 'not applicable (N/A)' and excluded from the analysis. The OSDI total score is calculated according to the following formula. The scale ranges from 0 to 100, with higher scores representing more severe cases of dry eye syndrome. * Changes at day-14 and day-28 will be compare with baseline measurements. * Comparison between groups at baseline, day-14 and day-28 will also be examined
次要结局
- Fluorescein and lissamine conjunctival and cornea staining (CFS)(Day-0 (baseline), day-7, and day-14)
- Meibomian gland function and secretion quality(Day-0 (baseline), day-7, and day-14)
- Tear Film Lipid Layer Score (TFLL)(Day-0 (baseline), day-7, and day-14)
- Tear meniscus height (TMH)(Day-0 (baseline), day-7, and day-14)
- Conjunctival hyperemia (RS score)(Day-0 (baseline), day-7, and day-14)