NCT07369375尚未招募不适用
Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VMX Eye Drops for the Treatment of Dry Eye Disease (DED)
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 76
- 主要终点
- Tear Break-up Time (TBUT)
研究概览
简要总结
This multicenter, randomized, double-blind study evaluates the safety and effectiveness of VMX eye drops in patients with dry eye disease. It aims to improve tear film stability, reduce dry eye symptoms, and enhance patients' quality of life compared to standard treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an age of ≥ 18 and ≤ 80 years
- •Patients with a diagnosis of Dry Eye (mild/moderate) with at least one of the following:
- •Tear Osmolarity >308 mOsm/L
- •TBUT < 10 seconds
- •Schirmer I test ≥ 5 mm and ≤ 14 mm at 5 minutes
- •Patients not treated with artificial tears for at least 7 days
- •Patients not treated with artificial tears for at least 7 days
排除标准
- •Use of systemic medications which may affect a dry eye condition within 1 month prior to study enrolment (e.g. low-dose aspirin, antihistamines, decongestants, antipsychotics, parkinsonism medications, anticholinergics, oral isotretinoin, and oral diazepam)
- •Patients with a score of ≤ 4 mm at 5 minutes on the Schirmer I test
- •Patients that suffer of ocular allergy pathology (seasonal and chronic)
- •Ongoing ocular or systemic infectious conditions
- •Use of topical ocular therapies that cannot be suspended for the entire duration of the study
- •Use of topical antibiotics and or corticosteroids within 15 days prior to study enrolment
- •Use of systemic antibiotics and or corticosteroids within 1 month prior to study enrolment
- •Any intraocular surgery in the past 12 months or require any intraocular surgery during the study
- •Acute and Chronic Conjunctival Disease
- •Eyelid surgery within the 6 months prior to study enrolment
- •Presence of congenitally absent lacrimal or Meibomian glands or have any obstructive disease of the lacrimal glands
- •History of ocular herpetic keratitis or active blepharitis in the 4 weeks prior to study enrolment
- •History of autoimmune diseases
- •Inflammations or abnormalities in the eyelid, in accordance with PI's clinical judgment
- •History of corneal diseases, as keratoconus
- •History of corneal transplant in one or both eyes
- •Keratinization of the eyelid margin
- •History of Sjögren's syndrome
- •History of corneal trauma in the last 4 weeks prior to study enrolment
- •Patients who are unwilling to discontinue all artificial tears and use only the study product ad indicated for the duration of the study
- •Inability to self-administer study medications
- •Women of childbearing potential who are pregnant, breast feeding, plan to become pregnant during the study, or not using adequate birth control methods to prevent pregnancy throughout the study.
- •Any hypersensitivity to the use of the study product formulations or an allergy to any ingredients contained within product formulation
- •Participation in other clinical studies involving drugs or devices within 30 days prior to study enrolment.
- •Patients legally or mentally incapacitated unable to give informed consent for the participation in this trial
- •Patients unable or unwilling to comply with appointments or all protocol requirements
研究组 & 干预措施
Treatment Group - VMX Eye Drops
Active Comparator
干预措施: VMX Eye Drops (Device)
Placebo Group - Placebo Eye Drops
Placebo Comparator
干预措施: placebo eye drops (Device)
结局指标
主要结局
Tear Break-up Time (TBUT)
时间窗: From Baseline (V1) to Visit 3 (V3 - Day 56 after first administration)
Assessment of the change in Tear Break-up Time (TBUT) at V3 versus V1 in the two groups.
次要结局
- Tear Break-up Time (TBUT)(From Baseline (V1) to Visit 2 (V2 - Day 17 after first administration))
- Schirmer I test(From Baseline (V1) to Visit 3 (V3 - Day 57 after first administration))
- Tear Osmolarity(From Baseline (V1) to Visit 3 (V3 - Day 57 after first administration))
- Ocular Surface Disease Index (OSDI) Questionnaire(From Baseline (V1) to Visit 3 (V3 - Day 57 after first administration))
- Standard Patient Evaluation of Eye Dryness Questionnaire (SPEED)(From Baseline (V1) to Visit 3 (V3 - Day 57 after first administration))
- Adverse Events(From first administration to Visit 3 (V3 - Day 57 after first administration))
研究者
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