EUCTR2021-003469-36-ES进行中（未招募）1 期
Prospective evaluation of the efficacy and safety of topical hydrocortisone treatment on clinical signs andsymptoms of dry eye disease associated with moderate meibomian gland dysfunction” - SOFT–MGD
aboratorios Théa, S.A.0 个研究点目标入组 54 人开始时间: 2021年7月15日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 54
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Age = 18 years
- •2.Documented diagnosis of DE defined by TBUT value = 5 seconds and Schirmer I test value < 10 mm/5 min
- •3.Normal ophthalmic findings except DED and MGD
- •4.OSDI score > 23 (moderate symptoms)
- •5.Documented diagnosis of MGD grade 2 to 3
- •6.Patient who can understand the instructions and adhere to medications
- •7.Patient who receives complete information regarding the study objectives, authorize their participation in the study and sign a written informed consent form (ICF) before entering in the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 27
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 27
排除标准
- •1.Any contraindication or known allergies to Lephanet®, Thealoz Duo®, MGD Rx EyeBag ® or Softacort® as per SmPC
- •2.Ocular surgery in the past 6 months
- •3.Ocular hypertension or glaucoma
- •4.Cicatricial MGD
- •5.Atopic condition including ocular allergy
- •6.Suspect demodex lid infestation as evidenced by the presence of collarettes
- •7.Intraocular inflammation
- •8.Confirmed infection with COVID-19 in the last 3 months
- •9.Systemic autoimmune disorder
- •10.Use of contact lenses during the month prior to inclusion in the study or during the study
- •11.Punctal occlusion
- •12.IOP > 22mmHg
- •13.Patient who has received topical or systemic anti-inflammatory treatments including corticosteroids and nonsteroidal anti-inflammatory drugs (NSAIDS) within 3 months prior to be included in the study or with a prescription for receiving topical / systemic anti-inflammatory treatments for the next 3 months
- •14.In the investigator´s opinion, use of systemic medications that could affect the function of the MG and tear production within 3 months prior to be included in the study
- •15.Any ocular or systemic disease known to affect the tear film, other than MGD
- •16.Patient with any situation or state that in the opinion of the investigator discourages their participation in the study
- •17.Patient participating in any other interventional or non-interventional study or who have participated in another study within 30 days prior to inclusion in this study
- •18.Women who are pregnant, planning to become pregnant or breastfeeding
- •19.Patient who will not be able to complete the study (e.g., not willing to attend the follow-up visits, way of life interfering with compliance)
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