Multi-centre, Randomised,Parallel-group, Controlled (Placebo), Double-blind Study to Evaluate the Efficacy, Ocular Tolerability and Safety of Vizol S Lipid Balance in the Adult Patient Population With Moderate to Severe Dry Eye for up to 30 Days
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Mean change in the tear film break-up time (TFBUT) from Visit 1 (baseline) to Visit 3 (day 30)
研究概览
简要总结
The clinical investigation was intended to investigate the efficacy, ocular tolerability and safety of Vizol S Lipid Balance, a new eye drops, emulsion developed by JADRAN - GALENSKI LABORATORIJ d.d., in patients with moderate to severe evaporative DED after a treatment for 30 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
As the clinical trial will be conducted in a double-blind way, both investigators and patients will be blind with respect to the treatment administered. For the purpose of individual unblinding of a patient's treatment the investigator will receive a sealed emergency envelope for each patient containing the treatment code (Only in case of medical emergency it is permitted to open the emergency envelope).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •use of eyelid hygiene for at least 14 days prior to screening
- •diagnosis of moderate to severe dry eye disease (DED), with an Ocular Surface Disease Index (OSDI) score ≥23
- •Tear Film Break-Up Time (TFBUT) <10 seconds in one or both eyes
- •Meibomian gland expression of grade 2 or higher in both eyes
- •written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the patients participating in the clinical trial
排除标准
- •intolerance or hypersensitivity to any component of the Investigational Product (IPs)
- •ocular or intraocular surgery or serious ocular trauma ≤6 months before enrolment
- •current punctal occlusion of any type
- •use of concomitant topical ocular medications within 24 hours prior to first intended administration of the IPs (except for artificial tears or lubricants; previously used artificial tears or lubricants must be suspended for the duration of the study)
- •use of systemic medications that may contribute to dry eye (unless on a stable regimen for ≥30 days before screening and throughout the study)
- •current or previous topical treatment of the eye with antibiotics, steroids or cyclosporin A within the last four weeks
- •ocular or systemic infections or conditions (e.g., epithelial herpes simplex keratitis, vaccinia, varicella, or mycobacterial infection, fungal disease, iritis) or other relevant ocular pathology judged by the investigator that preclude safe administration of the IPs
- •use of contact lenses within 1 week before screening and throughout the study
- •active ocular disease other than DED or any other acute or chronic disease which may interfere with the aims of the clinical trial
- •history of severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator
- •diagnosis of Corona Virus Disease (COVID-19) within the last 14 days prior to individual enrolment of the patient
- •contact to persons in international risk areas for COVID-19 as defined by the Institute of Public Health of Serbia within the last 14 days prior to individual enrolment of the patient
- •known direct contact with insufficient protection to persons with diagnosis of COVID-19 within the last 14 days prior to individual enrolment upon reporting of the patient
- •history of or current drug or alcohol dependence
- •participation in an investigational drug or device study ≤30 days before screening
- •positive pregnancy test at screening examination
- •pregnant or lactating women
- •female patients who do not agree to apply highly effective contraceptive methods (highly effective contraceptive methods are defined in chapter 13.2.1)
- •patients suspected or known not to follow instructions
- •patients who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical trial
研究组 & 干预措施
Vizol S LIPID BALANCE
topical administration of 1 drop of Vizol S LIPID BALANCE in each eye 4 times a day for 30 days
干预措施: Vizol S LIPID BALANCE eye drops (Drug)
ophthalmic saline eyedrops
topical administration of 1 drop of ophthalmic saline eye drops matching Vizol S LIPID BALANCE in each eye 4 times a day for 30 days
干预措施: ophthalmic saline eye drops (Drug)
结局指标
主要结局
Mean change in the tear film break-up time (TFBUT) from Visit 1 (baseline) to Visit 3 (day 30)
时间窗: baseline, week 2 follow-up and week 4 follow-up
Tear film break-up time (TFBUT) will be assessed at each visit following the instillation of fluorescein solution into the eye. Fluorescein will be instilled at the outer canthus to avoid ocular surface damage, with the excess saline on the strip shaken off, or a reduced area fluorescein strip used. Viewing will take place between 1 and 3 min after instillation. Three measurements per eye will be performed and the mean value documented and used for evaluation.
次要结局
- Mean change in the tear film break-up time (TFBUT) from Visit 1 (baseline) to Visit 2 (day 15)(baseline and week 2 follow-up)
- Mean change in OSDI score from Visit 1 (baseline) to Visit 3 (day 30)(baseline, week 2 follow-up and week 4 follow-up)
- percent (%) change in the tear film break-up time (TFBUT) from Visit 1 (baseline) to Visit 2 (day 15) and from Visit 1 (baseline) to Visit 3 (day 30)(baseline and week 2 follow-up; baseline and week 4 follow-up)
- Mean change in ocular surface staining score (total corneal and total conjunctival staining score) from Visit 1 (baseline) to Visit 3 (day 30)(baseline, week 2 follow-up and week 4 follow-up)
- Mean change in Meibomian gland expression from Visit 1 (baseline) to Visit 3 (day 30)(baseline, week 2 follow-up and week 4 follow-up)