Tolerability and Efficacy of Reinnerva/Lubristil+G vs Vismed in the Treatment of the Ocular Surface of Patients With Quali-quantitative Alteration of Lacrimal Film of Different Origins
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Clinical Performance and Benefit
研究概览
简要总结
The clinical investigation #1122 is a Post Market Clinical Follow Up Study on the EC marked medical device Reinnerva/Lubristil +G, sterile eye drops, compared to Vismed medical device, sterile eye drops, to demonstrate the clinical performance and tolerability of Reinnerva/Lubristil +G to stabilize the lacrimal film and improve the ocular surface condition in the cases of quali-quantitative alterations of the tear film .
详细描述
The study aim was to demonstrate a significant improvement of the ocular surface condition with the use of Reinnerva/Lubristil +G that, based on its formulation: hydrates, stabilizes and protects the ocular surface in all cases of sensations of dryness, burning and ocular fatigue due to qualitative and quantitative alteration of the tear film.
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 (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
- •Signed informed consent
- •Male and female, aged 18 to 80 years
- •Alteration of the tear film or bilateral ocular surface discomfort resulting from one of the following conditions:
- •Patients receiving chronic therapy with antihypertensive eye drops; Patients receiving post-ocular surgery therapy for at least 15 days
- •At least two of the following symptoms of dry eye: burning, stinging, dry eye sensation, foreign body sensation, photophobia
- •At least two of the following:
- •Schirmer's test (8 mm lower in 5 minutes) BUT (Burning Time) less than 10 seconds Fluorescein Infection Infection (NEI) score ≥3
排除标准
- •Active keratitis caused by herpes simplex, vaccinia virus, varicella-zoster, and other viral infections of the cornea and conjunctiva
- •Current bacterial, fungal, and tuberculosis infections
- •Corneal stromal perforations and ulcers
- •Hypersensitivity to any of the product components
- •Current ocular allergy or allergic rhinitis
- •Participation in a clinical trial in the month prior to the start of the study
- •Systemic anti-acne therapy in the 6 months prior to the start of the study
- •Any change in systemic therapy in the month prior to the start of the study
- •Contact lens use in the week prior to the start of the study
研究组 & 干预措施
Reinnerva/Lubristil +G
25 patients (17 of these participants were post-surgical and 8 glacomatous) received Reinnerva/Lubristil +G, sterile eye drops, 2 drops in 1 eye, twice daily for 60 days .
干预措施: Reinnerva/Lubristil +G sterile eye drops (artificial tears) (Device)
Vismed
15 patients (11 of these participants were post-surgical and 4 glacomatous) received Vismed, sterile eye drops, 2 drops in 1 eye, 4 times daily for 60 days .
干预措施: Vismed sterile eye drops (artificial tears) (Device)
结局指标
主要结局
Clinical Performance and Benefit
时间窗: From enrollment to the end of treatment at 30 and 60 days.
Demonstrate the ability of Reinnerva/Lubristil + G to significantly improve the condition of the ocular surface assessed through subjective symptomatology expressed according to SANDE. The efficacy analysis has been evaluated by: \- Change in symptoms measured by a questionnaire (SANDE - Symptom Assessment in Dry Eye) to assess patient well-being. Unit of Measure: The SANDE is based on a visual analog scale (VAS). The patient answers only two questions regarding the frequency and severity of symptoms. For each question, a 100-millimeter horizontal line is provided: Symptom Frequency: From "Rarely" (0 mm) to "All the Time" (100 mm). Symptom Severity: From "Very Mild" (0 mm) to "Very Severe" (100 mm). The final measurement (Final Score) is a numerical value between 0 and 100. The total score is obtained by calculating the square root of the product of the two scales. Parameters have been evaluated at the following times: T0 - screening, T30 - day 30 ± 3 days, T60 - day 60 ± 3 days
Safety/Tolerability
时间窗: From enrollment to the end of treatment at 30 and 60 days.
Adverse Events (AEs): Information regarding any medical device (eye drops) defect or event reported by a patient or investigator has been monitored at each investigational visit. Safety and tolerability analyses have included the number of adverse events occurred during the study in the treatment group and the percentage of patients with at least one adverse event judged to be related to the medical device under study
次要结局
未报告次要终点