Management of Dry Eye With Intense Pulsed Light in Combination With Diquafosol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Non-invasive tear break-up time (NIBUT)
研究概览
简要总结
Intense pulsed light (IPL) has been reported to improve signs and symptoms of dry eye (DE). Additionally, meibomian gland secretion of lipids has been observed to improve through the use of IPL. Diquafosol ophthalmic solution (DQS) stimulates P2Y2 receptors on the ocular surface, which enhances mucin secretion from goblet cells. Therefore, tear film stability and hydration of the ocular surface can be achieved independent from lacrimal glands function. The purpose of this prospective study was to evaluate and compare the effects of IPL (IPL group), DQS (DQS group) and IPL in combination with DQS (IPL+ group) in participants with persistent DE. Tear film lipid layer (TFLL), non-invasive breakup time (NITBUT), tear meniscus height (TMH), corneoconjunctival staining score (CS), meibum gland (MG) function, conjunctival hyperemia (RS score), ocular surface disease index (OSDI) will be assessed and compared at baseline, day-14, and day-28.
详细描述
Evaporative dry eye (EDE) has been reported to be the most prevalent form of dry eye disease (DED), which is primarily caused by meibomian gland hypofunction or meibomian gland dysfunction (MGD). MGD is defined as ''a chronic, diffuse anomaly of the meibomian glands, often characterized by terminal duct blockage and/or qualitative/quantitative alterations in glandular secretion'' by the International Workshop on MGD.These glands are modified sebaceous glands that release meibum directly onto the ocular surface. Signs and symptoms of EDE and MGD can be addressed by improving the quality and quantity of meibum secretion.
Intense pulsed light (IPL) is widely used to treat dermatological conditions, and its noncoherent polychromatic light source with wide wavelength range of 500-1200 nm has been reported to stimulate facial sebaceous glands. The photothermal effect of IPL is postulated to relieve inflammation by removing aberrant surface microvasculature and enhances meibomian gland function. Furthermore, an increase in fibroblast proliferation, collagen formation and local blood flow has been associated with the application of IPL on the skin. Several studies have documented the benefits of IPL in alleviating signs and symptoms of DED on the periocular skin.
Diquafosol ophthalmic solution (DQS) is a dinucleotide polyphosphate which a purinoceptor agonist, when administered to the ocular surface, it binds to P2Y2 receptors and stimulates mucin and tear secretion. The corneal epithelium, conjunctival epithelium, lacrimal gland ductal epithelium, meibomian gland sebaceous cells, and meibomian gland ductal cells all express the P2Y2 receptor. Subsequently, enhanced secretion of mucin and tear secretion due to DQS ophthalmic solution leads to stabilization of the tear film, minimizes tear evaporation, and reduces mechanical friction thereby protecting the corneal epithelium.
The purpose of this study is to assess the management of DE by combining IPL and DQS eye drops.
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
- •Consenting participants
- •Able and willing to comply with the treatment/follow-up schedule
- •Bilateral signs and symptoms of dry eye disease: (i) Ocular Surface Disease Index (OSDI) questionnaire ≥13, (ii) Non-invasive tear break-up (NITBUT) ≤ 5 seconds, (iii) conjunctival staining score (CS) ≥3 points. The presence of two or more criteria was used to establish a positive DE diagnosis based on the 2016 Asia Dry Eye Society criteria
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.
- •Active allergy or infection, or inflammatory disease may prevent the subjects from completing the study at the ocular surface.
- •Any structural changes in the lacrimal passage
- •Diabetes or other systemic, dermatologic, or neurologic diseases that affect the health of the ocular surface.
- •Use of any systemic anti-inflammatory drugs or medication that may interfere with tear production, such as antianxiety, anti-depressive, and antihistamine medications, within three months.
- •Pregnancy or breastfeeding
- •Contact lenses wearers.
研究组 & 干预措施
IPL+
Participants in the IPL+ group used DQS 1 drop 6 times/per day for four weeks along with 2 sessions of IPL, 2 weeks apart.
干预措施: Intense pulsed light (Device)
IPL+
Participants in the IPL+ group used DQS 1 drop 6 times/per day for four weeks along with 2 sessions of IPL, 2 weeks apart.
干预措施: Diquafosol tetrasodium (Drug)
IPL
IPL treatment sessions were administered once at 2- weeks interval to all participants for 4 weeks.
干预措施: Intense pulsed light (Device)
DQS
DQS group will be administered one drop of 3% DQS (Diquas, Santen Pharmaceutical Co., Ltd., Osaka, Japan) six times per day for 4 weeks.
干预措施: Diquafosol tetrasodium (Drug)
结局指标
主要结局
Non-invasive tear break-up time (NIBUT)
时间窗: Day-0 (baseline), day-14 and day-28
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-14 and day-28
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-14 and day-28)
- Meibomian gland function and secretion quality(Day-0 (baseline), day-14 and day-28)
- Tear Film Lipid Layer Score (TFLL)(Day-0 (baseline), day-14 and day-28)
- Tear meniscus height (TMH)(Day-0 (baseline), day-14 and day-28)
- Conjunctival hyperemia (RS score)(Day-0 (baseline), day-14 and day-28)