Clinical Trial for the Evaluation of I+Med's DayDrop Advanced Ophthalmic Drop in Improving Signs and Symptoms of Mild/Moderate Dry Eye
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Changes in the intensity of dry eye measured by Schirmer's test.
研究概览
简要总结
Clinical trial conducted with the aim of evaluating changes in the signs of dry eye through the change in the amount of tears produced, measured through the Schirmer test. It will be performed in 45 patients diagnosed with mild/moderate dry eye who meet the inclusion/exclusion criteria. Follow-up will be 12 weeks with a maximum of 4 visits.
详细描述
Historically, dry eye disease (DED) has been considered largely due to tear insufficiency and has been treated by prescribing tear substitutes. The replacement of tears with ocular lubricants has traditionally been considered a cornerstone of DED treatment, and there are numerous topical formulas available.
In this regard, DayDrop Advanced introduces as an innovation the inclusion of gamma poly(glutamic acid) (γ-PGA) in its composition.
The product under investigation, DayDrop Advanced, is a sterile ocular lubricant drop based on γ-PGA and hyaluronic acid. It is a biocompatible solution, phosphate-free, preservative-free, and compatible with contact lenses. It has suitable mechanical properties that stabilize and protect the ocular surface while maintaining a moist local environment. Due to its components' high water retention capacity and viscosity, this ophthalmic drop helps clean, hydrate, and lubricate the ocular surface. It supplements the tear film, relieving pain, dryness, and eye irritation.
This clinical research is part of the product development and forms the basis for obtaining its certification, aiming to demonstrate both the safety and effectiveness of the product. The preparation and execution of the protocol or research plan have taken into account the recommendations of TFOS DEWS II and followed the guidelines of good clinical practice ICH-GCP E6 (R2) , as well as the recommendations of the principal investigator of the study.
It consists of a quasi-experimental before-and-after clinical trial in patients diagnosed with mild/moderate dry eye. Mild/moderate dry eye is defined as a condition that produces symptoms in the patient and may or may not have detectable signs under the slit lamp, but which can disappear with appropriate treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients of both sexes over 18 years of age.
- •Patients diagnosed with mild-moderate dry eye who meet the following characteristics: Schirmer test ≥3 and ≤ 10 mm; BUT test ≥5 and ≤ 10 seconds and OSDI ≥13 and ≤
- •Patients without other ophthalmologic pathologies.
- •Have ability to self-administer drops.
- •Have ability to understand the Patient Information Sheet.
- •Sign the Informed Consent.
排除标准
- •Patients diagnosed with severe dry eye.
- •Ingestion of parasympathomimetic or antipsychotic medications .
- •Glaucoma.
- •Previous cataract surgery.
- •Systemic treatment with corticosteroids or topical treatment with any ophthalmic medication except artificial tears in the week prior to the start of study treatment.
- •Ocular infection or clinically significant inflammation.
- •Ocular surgery in the 3 months prior to the study.
- •Sjögren's syndrome.
- •Stevens-Johnson syndrome.
- •History of allergic conjunctivitis.
- •Pregnancy or planned lactation.
结局指标
主要结局
Changes in the intensity of dry eye measured by Schirmer's test.
时间窗: At baseline, in week 4 and in week 12
The Schirmer test measures the amount of tears produced in mm of wetted strip.A greater distance in the Schirmer test implies a higher amount of tears produced and therefore a lower intensity of dry eye.
次要结局
- Changes in dry eye signs through modifications in tear film thickness measured by Optical Coherence Tomography.(At baseline, in week 4 and in week 12)
- Changes in dry eye signs through the tear breakup time measured by TBUT test.(At baseline, in week 4 and in week 12)
- Changes in dry eye symptoms through the OSDI scale.(At baseline, in week 4 and in week 12)
- Satisfaction with Treatment.(At Week 12)
- Adverse events.(Through study completion, apprroximately 12 weeks)