Post-marketing Study to Evaluate the Efficacy of I+MED's DayDrop in Improving Mild/Moderate Dry Eye Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in the score obtained in the OSDI questionnaire.
研究概览
简要总结
Clinical post-marketing quasi-experimental before-and-after trial to determine the effectiveness of DayDrop treatment in subjects seeking relief from symptoms of dryness and eye irritation based on OSDI questionnaire scores completed by patients.The study will involve 20 patients diagnosed with mild/moderate dry eye disease who meet the inclusion/exclusion criteria. The duration of the study will be 2 weeks, including 3 visits.
详细描述
Clinical post-marketing quasi-experimental before-and-after trial to determine the effectiveness of DayDrop treatment in subjects seeking relief from the signs of dryness and eye irritation, comparing the scores obtained at the end of the follow-up period with those established before the start of treatment (baseline condition), as measured by the patients according to the OSDI questionnaire.
The study will involve 20 patients diagnosed with mild/moderate dry eye disease who meet the inclusion/exclusion criteria of the protocol. The study duration will be 2 weeks, including 3 visits: baseline, visit 1 (after one week of treatment), and visit 2 (at 2 weeks from the start of 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 presenting symptoms of dryness and ocular irritation with an OSDI score ≥13 and ≤
- •Ability to self-administer the drops.
- •Ability to understand the Patient Information Sheet and sign the Informed Consent.
- •Willingness and sufficient ability, as judged by the investigator, to respond to the questionnaires included in the study.
排除标准
- •Pregnant women or those in the breastfeeding period.
- •Known allergy or hypersensitivity to hyaluronic acid or any other ingredient in the product being studied.
- •Patients who have undergone previous ocular surgery or experienced ocular trauma in the year prior to the start of the study.
- •Severe dry eye diagnosis.
- •Presence of inflammatory ocular surface pathology or anterior segment disease, or diagnosed with glaucoma.
- •Use of parasympathomimetic or antipsychotic medications.
- •Previous cataract surgery.
- •Systemic corticosteroid treatment or topical treatment with any ophthalmic medication, except artificial tears, in the week before the start of the study.
- •Sjögren's syndrome.
- •Stevens-Johnson syndrome.
- •History of allergic conjunctivitis.
结局指标
主要结局
Change in the score obtained in the OSDI questionnaire.
时间窗: At baseline and in week 3
The OSDI questionnaire will be completed by the patients and is used to analyze the presence of progress in dry eye symptoms. The 12 questions of the OSDI questionnaire will be used to calculate the index (total score range from 0 to 48). The score obtained for these parameters at the start of the study (baseline) will be compared with the score obtained at the end of the follow-up period. To support the hypothesis of effectiveness, treatment with DayDrop will result in a significant improvement (of at least 6 points out of 48) in the OSDI index scores at the end of the follow-up period, compared to the values recorded at the start of the study.
次要结局
- Change in the score obtained in the OSDI questionnaire at week 1.(At week 1)
- Assessment by the investigators of the treatment's effectiveness.(At week 2)
- Evaluation by the subjects of the treatment's effectiveness.(At week 2)
- Adverse events.(Through study completion, apprroximately 3 weeks)