Prospective Evaluation of the Efficacy and Safety of Topical Hydrocortisone Treatment on Clinical Signs and Symptoms of Dry Eye Disease Associated With Moderate Meibomian Gland Dysfunction
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Safety endpoint: Incidence of increased intraocular pressure and change from baseline at Day 0, Day 14, Day 28 and Day 84
研究概览
简要总结
The purpose of this study is assess the efficacy and safety of topical hydrocortisone (Softacort) for treatment of clinical signs and symptoms of dry eye disease when associated with moderate meibomian gland dysfunction.
详细描述
This is a prospective, interventional, randomized (1:1), single blind, of parallel groups and two treatment arms clinical trial (phase IV).
All patients diagnosed with dry eye disease (DED) associated with moderate MGD may participate in the study if they meet all the selection criteria.
Patients (or their representatives) will provide informed consent (IC) prior to the enrolment in the study and to the start of data collection. Patients must meet all the inclusion criteria and not meet any of the exclusion criteria.
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
- Single (Investigator)
盲法说明
This is a single-blinded study for the PI or person designated to conduct the study (blinded investigator). Study medication will be labelled as blinded medication. The prescription will be done by the blinded investigator using a kit number, and study medication delivery will be done by a person designed by the PI for this topic through the study (unblinded collaborator). Patients will be instructed not to inform the investigators who perform the ophthalmological evaluation about the group they will be assigned to. Patient assessments will be performed by blinded investigator.
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
- •Age ≥ 18 years
- •Documented diagnosis of DE defined by TBUT value ≤ 5 seconds and Schirmer I test value < 10 mm/5 min
- •Normal ophthalmic findings except dry eye disease and meibomian gland dysfunction
- •OSDI score > 23 (moderate symptoms)
- •Documented diagnosis of MGD grade 2 to 3
- •Patient who can understand the instructions and adhere to medications
- •Patient who receives complete information regarding the study objectives, authorize their participation in the study and sign an informed consent form before entering in the study
排除标准
- •Any contraindication or known allergies to Lephanet®, Thealoz Duo®, MGD Rx EyeBag® or Softacort®
- •Ocular surgery in the past 6 months
- •Ocular hypertension or glaucoma
- •Cicatricial MGD
- •Atopic condition including ocular allergy
- •Suspect demodex lid infestation as evidenced by the presence of collarettes
- •Intraocular inflammation
- •Confirmed infection with COVID-19 in the last 3 months
- •Systemic autoimmune disorder
- •Use of contact lenses during the month prior to inclusion in the study or during the study
- •Punctal occlusion
- •Intraocular pressure > 22 mmHg
- •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
- •In the investigator´s opinion, use of systemic medications that could affect the function of the meibomian gland and tear production within 3 months prior to be included in the study
- •Any ocular or systemic disease known to affect the tear film other than MGD
- •Patient with any situation or state that in the opinion of the investigator discourages their participation in the study
- •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
- •Women who are pregnant, planning to become pregnant or breastfeeding
- •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)
研究组 & 干预措施
Intervention group
Softacort® Lephanet® Thealoz Duo® MGD Rx EyeBag®
干预措施: Hydrocortisone Ophthalmic (Drug)
Intervention group
Softacort® Lephanet® Thealoz Duo® MGD Rx EyeBag®
干预措施: MGD Rx EyeBag® eyelid warming device (Device)
Intervention group
Softacort® Lephanet® Thealoz Duo® MGD Rx EyeBag®
干预措施: Lephanet® lid wipes (Device)
Intervention group
Softacort® Lephanet® Thealoz Duo® MGD Rx EyeBag®
干预措施: Thealoz Duo® artificial tear with trehalose 3% and sodium hyaluronate 0.15% (Device)
Control group
Lephanet® Thealoz Duo® MGD Rx EyeBag®
干预措施: MGD Rx EyeBag® eyelid warming device (Device)
Control group
Lephanet® Thealoz Duo® MGD Rx EyeBag®
干预措施: Lephanet® lid wipes (Device)
Control group
Lephanet® Thealoz Duo® MGD Rx EyeBag®
干预措施: Thealoz Duo® artificial tear with trehalose 3% and sodium hyaluronate 0.15% (Device)
结局指标
主要结局
Safety endpoint: Incidence of increased intraocular pressure and change from baseline at Day 0, Day 14, Day 28 and Day 84
时间窗: Day 0, Day 14, Day 28 and Day 84
Mean of 3 measures of intraocular pressure measured with Goldmann tonometer in each eye on Day 0, Day 14, Day 28 and Day 84. Increased intraocular pressure defined as \>21 mmHg.
Efficacy endpoint: Change from baseline in Meibomian Gland Dysfunction Dry Eye symptom score (MGD-DE) at 14 days
时间窗: Day 0 and Day 14
Meibomian Gland Dysfunction Dry Eye symptom score (MGD-DE) calculated by the sum of the Visual Analogue scale (VAS) score assigned by the patient on a scale from 0 (no symptoms) to 100 (worst symptoms) in the following symptoms: itching, dry eye sensation, burning, foreign body sensation and ocular redness.
次要结局
- Change from baseline in ocular symptoms Visual Analogue scale (VAS) questionnaire at Day 14, Day 28 and Day 84(Day 0, Day 14, Day 28 and Day 84)
- Change from baseline in Ocular Surface Disease Index (OSDI) questionnaire at Day 14, Day 28 and Day 84(Day 0, Day 14, Day 28 and Day 84.)
- Change from baseline in Tear break up time (TBUT) at Day 14, Day 28 and Day 84(Day 0, Day 14, Day 28 and Day 84)
- Change from baseline in Schirmer I test at Day 14, Day 28 and Day 84(Day 0, Day 14, Day 28 and Day 84)
- Change from baseline in hyperemia score (McMonnies-Chapman scale) at Day 14, Day 28 and Day 84.(Day 0, Day 14, Day 28 and Day 84)
- Change from baseline in Lissamine green staining score at Day 14, Day 28 and Day 84(Day 0, Day 14, Day 28 and Day 84)
- Change from baseline in tear inflammatory cytokines at Day 14(Day 0 and Day 14.)
- Change from baseline in Meibomian Gland Dysfunction Dry Eye symptom score at Day 14, Day 28 and Day 84(Day 0, Day 14, Day 28 and Day 84.)
- Change from baseline in corneal and conjunctival staining with fluorescein (Oxford grading scale) at Day 14, Day 28 and Day 84(Day 0, Day 14, Day 28 and Day 84)
- Change from baseline in meniscus height at Day 14, Day 28 and Day 84(Day 0, Day 14, Day 28 and Day 84)
- Change from baseline in MGD grading at Day 14, Day 28 and Day 84(Day 0, Day 14, Day 28 and Day 84)
- Change from baseline in lid abnormalities at Day 14, Day 28 and Day 84(Day 0, Day 14, Day 28 and Day 84)
- Incidence of adverse events and serious adverse events occurred during the study.(Day 0, Day 14, Day 28 and Day 84)
- Change from baseline in corneal and conjunctival staining with lissamine green (Van Bijsterveld scale) at Day 14, Day 28 and Day 84(Day 0, Day 14, Day 28 and Day 84)
- Change from baseline in Eyelid telangiectasia score at Day 14, Day 28 and Day 84(Day 0, Day 14, Day 28 and Day 84)
- Change from baseline in Meibomian gland expressibility score at Day 14, Day 28 and Day 84(Day 0, Day 14, Day 28 and Day 84)
- Change from baseline in ETDRS visual acuity at Day 14, Day 28 and Day 84(Day 0, Day 14, Day 28 and Day 84)