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临床试验/NCT06174064
NCT06174064尚未招募不适用

Broadband Light for the Treatment of Dry Eye Disease and Meibomian Gland Dysfunction

University of Southern California0 个研究点目标入组 60 人开始时间: 2024年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
Change in dry eye score

研究概览

简要总结

The investigators will be evaluating the use of broadband light in Dry Eye and Meibomian Gland Dysfunction.

详细描述

Broadband light (BBL) is a widely used treatment for improvement of inflammatory dermatologic conditions such as acne and rosacea, and may have similar therapeutic benefits on the treatment of dry eye disease by targeting inflammation of the eyelids. The investigators propose a prospective study to determine the safety and efficacy of BBL treatment on patients with dry eye disease and meibomian gland dysfunction. Each participant will have three treatments of BBL at monthly intervals to the cheek and periorbital area with subsequent follow up. Measured endpoints will include signs and symptoms of dry eye control including full ophthalmic exam, dry eye diagnostic testing, photographs, and standardized questionnaires.

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

Patients will be randomized to protocol 1, 2, or sham but will not be aware of their assignment; investigators grading dry eye at baseline and after treatment will not be aware of which protocol the patients underwent.

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Fitzpatrick Skin Type I-V
  • Must be diagnosed with Dry eye disease (DED) and meibomian gland dysfunction (MGD)
  • Persistent dry eye signs and or symptoms after at least one prior DED treatment modality

排除标准

  • Prior Intense pulsed light treatment for DED within the past six months
  • Prior Meibomian gland treatment with a device for DED within the past three months
  • History of trauma-induced ocular surface disease (thermal burns, chemical burns)
  • Subject is pregnant
  • History of seizures
  • Having significant unprotected sun exposure within the treatment area
  • Use of Accutane within the last six months
  • Use of doxycycline in the last 1 month
  • Allergy to proparacaine or lidocaine
  • Having active herpes simplex virus infection within the treatment area
  • Laser eye surgery (LASIK) within the past twelve months
  • History of abnormal response to sunlight
  • Having an active medical condition that may affect normal healing
  • Having active infections or compromised immune system
  • History of basal cell carcinoma in the treatment area within the past twelve months
  • History of keloid scar formation

结局指标

主要结局

Change in dry eye score

时间窗: 1 month after last BBL treatment (4 month time-point)

Change in SPEED dry eye disease questionnaire score from baseline to 1 month post-treatment

次要结局

  • Ocular surface/eyelid microbiome data(1 month after last BBL treatment)
  • Clinical evaluation of dry eye-- Change in fluorescein staining grade(1 month after last BBL treatment)
  • Clinical evaluation of dry eye--Change in tear osmolarity(1 month after last BBL treatment)
  • Clinical evaluation of dry eye--Change in Matrix metalloproteinase-9 (MMP-9) presence in significant concentration(1 month after last BBL treatment)
  • Clinical evaluation of dry eye--Change in tear breakup time(1 month after last BBL treatment)
  • Clinical evaluation of dry eye--Change in basal tear production(1 month after last BBL treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sandy Zhang-Nunes

Director of Oculoplastics, USC Roski Eye Institute

University of Southern California

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