Evaluation of Dry Eye Disease's Signs in Patients Who Were Administered Intravitreal Injections
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Administration of Ocular Surface Disease Index (OSDI) to the patient
研究概览
简要总结
The goal of this interventional, monocentric, prospective, single-masked, case-control study is to evaluate the efficacy of Thealoz Duo (artificial tear containing trehalose 3 g and hyaluronic acid 0.15 g) in comparison to a saline solution (Hydrabak containing Sodium Chloride 0,9 g, Sodium Dihydrogen Phosphate Dihydrate, Disodium Hydrogen Phosphate Dodecahydrate), to reduce the signs of ocular discomfort and ocular side effects in patients who have received Intravitreal injections.
The main questions it aims to answer are:
- can ocular instillation of Thealoz Duo solution, 1 week before intravitreal injection, in a fixed dose regimen, prevent ocular surface changes and dry-eye signs?
- can ocular instillation of Thealoz Duo solution, up 3 months after intravitreal injections, in a fixed dose regimen, reduce ocular surface changes, and dry-eye signs with improvement of quality of life and quality of vision?
Each participant will be randomized into each of two arms:
- TREATMENT ARM: patients who will receive the instillation of Thealoz Duo, 10 ml, 1 drop, 4 times/day;
- CONTROL ARM: patients who will receive the instillation of saline solution (Hydrabak), 10 ml, 1 drop, 4 times /day;
The decision of inclusion of a control group should minimize the risk of breaking the blinding condition by affecting the consistency and reliability of the outcome's achievement.
In any case, the instillation of saline solution should not alter the ocular surface.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
There are two teams:
- MASKED TEAM: Sub-investigators and study coordinators delegated to perform the following tasks:
- dispensation to the patient the Investigational medical device (Thealoz Duo) or saline solution (Hydrabak containing Sodium Chloride 0,9 g, Sodium Dihydrogen Phosphate Dihydrate, Disodium Hydrogen Phosphate Dodecahydrate);
- accountability of Investigational medical device and saline solution;
- verify the compliance and therapeutic adherence of the patient;
- discussion with the patient regarding the respect of the masked condition of the study;
- UNMASKED TEAMS:
- informed consent process;
- to perform the follow-up visit and assessments provided to test the ocular surface.
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
- •patient with retinal disease who required anti-VEGF therapy via intravitreal injections;
- •patient who has already received at least 2 anti-VEGF therapy via intravitreal injections in the study eye during the last 6 months before the baseline;
- •Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
排除标准
- •patient with naive retinal disease who has already received < 2 anti-VEGF therapy via intravitreal injections in the study eye;
- •subjects with autoimmune pathologies involving the ocular surface (e.g.Sjögren's syndrome), dry eye syndrome, eyelid disease that can induce changes in ocular surface (e.g. entropion, ectropion, lagophthalmos, trichiasis, ptosis), with any other systemic disease that may confound the interpretation of study results.
研究组 & 干预措施
treatment arm
Installation of artificial tears of Thealoz DUO (Investigational medical device containing trehalose 3 g and hyaluronic acid 0.15 g ), 10 ml.
Dosage:1 drop x 4 times/day by 1 week before the Intravitreal injection until 3 months afterward.
干预措施: Thealoz Duo; (Device)
control arm
Installation of saline solution (Hydrabak containing Sodium Chloride 0,9 g, Sodium Dihydrogen Phosphate Dihydrate, Disodium Hydrogen Phosphate Dodecahydrate),10 ml.
Dosage: 1 drop x 4 times/day by 1 week before the Intravitreal injection up to 3 months after it.
干预措施: sham (Hydrabak) (Device)
结局指标
主要结局
Administration of Ocular Surface Disease Index (OSDI) to the patient
时间窗: 3 months and 1 week
The primary outcome is to evaluate the improvement of the dry-eye signs and changes in the ocular surface in patients who have received the intravitreal injections through the administration of Ocular Surface Disease Index (OSDI) at baseline, at month 1 and month 3 after the intravitreal injections.
次要结局
- Schirmer's test(3 months and 1 week)
- tear film Break Up Time (tBUT)(3 months and 1 week)
- conjunctival hyperemia according to Efron grading scale(3 months and 1 week)
- fluorescein staining(3 months and 1 week)
- evaluation of matrix metalloproteinase 9 gene expression(3 months and 1 week)
- administration of Visual Analog Scale for Pain to the patient(3 months and 1 week)
- TearLab Osmolarity(3 months and 1 week)
研究者
Francesco Bandello
Full Professor and Chairman of Department of Ophthalmology
IRCCS Ospedale San Raffaele