NCT07050446已完成3 期
Multicentre, Randomized, Controlled, Double-blind, Parallel Design Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Vizol S DIGI EYE in the Adult Patient Population With Moderate to Severe Dry Eye Disease for up to 28 Days
Jadran Galenski laboratorij d.d.3 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2024年3月20日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 3
- 主要终点
- Mean change in the tear film break-up time (TFBUT) from Visit 1 (baseline) to Visit 2 (day 14)
研究概览
简要总结
The clinical investigation was intended to investigate the efficacy, ocular tolerability and safety of Vizol S DIGI EYE, a new eye drops, solution developed by JADRAN - GALENSKI LABORATORIJ d.d., in patients with moderate to severe evaporative DED after a treatment for 28 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
- •≥18 years of age;
- •Diagnosis of moderate to severe dry eye disease (DED) with a baseline
- •Ocular Surface Disease Index (OSDI) score ≥23 (approximately 15% of the population should wear contact lenses);
- •Tear Film Break-Up Time (TBUT) <10 s in one or both eyes at baseline;
- •National Eye Institute (NEI) score for corneal fluorescein surface staining >5/15 and for conjunctival fluorescein surface staining >6/18 at baseline;
- •Best corrected visual acuity (BCVA) of ≥20/80 (or ≥55 letters score or ≥0.6 Early Treatment Diabetic Retinopathy Study log of the minimum angle of resolution value) in both eyes at screening;
- •Use of electronic devices (e.g., computers, laptops, smart phones, tablets, televisions (TVs), electronic book readers) with digital screens for more than 6 hours daily;
- •Use of eyelid hygiene for at least 14 days prior to screening;
- •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
- •History of hypersensitivity or intolerance to any component of investigational product (IP);
- •History of hypersensitivity to fluorescein;
- •Any active ocular disease or any anterior ocular surface findings (diseases and irregularities) other than dry eye disease;
- •Ocular or refractive surgery (e.g., LASIK, photorefractive keratectomy (PRK) etc.) within the last 12 months from screening;
- •Current punctual occlusion of any type;
- •History of ocular trauma;
- •History of herpes simplex or herpes zoster keratitis;
- •History of any type of corneal ulcers;
- •Any other acute or chronic disease which may interfere with the aims of the clinical trial or other relevant ocular pathology judged by the investigator that preclude safe administration of the IPs;
- •Systemic diseases that alter the ocular surface;
- •History of severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator;
- •History of malignancy (other than localized basal cell carcinoma of the skin or in situ cervical cancer);
- •Use any topical ophthalmic medication within the last 30 days (except for artificial tears or lubricants; patients will be required to discontinue any other artificial tear or lubricants within the last 14 days and during the trial);
- •Use of systemic medications that may contribute to dry eye (unless on a stable regimen for ≥30 days before screening and throughout the study);
- •History of or current drug or alcohol dependence;
- •Positive Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) test;
- •History of Coronavirus Disease 2019 (COVID-19) within the last 30 days (to be defined in line with national requirements);
- •History of direct contact with insufficient protection to persons with COVID-19 within the last 14 days (to be defined in line with national requirements);
- •Pregnancy or breastfeeding;
- •Female patients with childbearing potential (any female after menarche unless postmenopausal for ≥12 months, or surgically sterilized) who are not willing to use a highly effective method of contraception during the study;
- •Positive pregnancy test, for female patients with childbearing potential only;
- •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;
- •Participation in another clinical trial within 3 months before screening or over a period of 5 half-lives, or double duration of the biological effect of the investigational product received, whichever is longer.
研究组 & 干预措施
0,9% saline solution, eyedrops
Placebo Comparator
topical administration of 1 drop of 0,9% saline solution, eyedrops matching Vizol S DIGI EYE in each eye 4 times a day for 28 days
干预措施: 0,9% saline solution, eye drops (Drug)
Vizol S DIGI EYE
Experimental
topical administration of 1 drop of Vizol S DIGI EYE in each eye 4 times a day for 28 days
干预措施: Vizol S DIGI EYE 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 2 (day 14)
时间窗: baseline and week 2 follow up
Tear film break-up time (TBUT) will be assessed 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. Two measurements per eye will be performed and the mean value documented and used for evaluation.
次要结局
- percent (%) change in the tear film break-up time (TFBUT) from Visit 1 (baseline) to Visit 2 (day 14) and from Visit 1 (baseline) to Visit 3 (day 28)(baseline and week 2 follow-up; baseline and week 4 follow-up)
- change in the tear film break-up time (TFBUT) on Visit 1 (day 1)(baseline and 4 hour after 1st application)
- Mean change in ocular surface disease index (OSDI) score from Visit 1 (baseline) to Visit 2 (day 14) and Visit 3 (day 28)(baseline, week 2 follow-up and week 4 follow-up)
- Change in Dry Eye Symptom Score (DESS) on Visit 1 (day 1)(baseline and 0, 4 and 8±1 hour after 1st application)
- Change in Soothing Sensation Score (SSS) on Visit 1 (day 1)(baseline and 0, 4 and 8±1 hour after 1st application)
- Mean changes in ocular surface staining score (OSS) (total corneal and total conjunctival staining score) from Visit 1 (baseline) to Visit 2 (day 14) and Visit 1 to Visit 3 (day 28)(baseline, week 2 follow-up and week 4 follow-up)
- Mean change in the tear film break-up time (TFBUT) from Visit 1 (baseline) to Visit 3 (day 28)(baseline and week 4 follow up)
- Change in Refreshing Effect Score (RES) on Visit 1 (day 1)(0, 0.25 and 1 hour after 1st application)
研究者
研究点 (3)
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