Study of Non-inferiority Between Manzanilla Sophia® and Meticel Ofteno® 0.5% for Providing a Relief Sensation to the Eyes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- To demonstrate the non-inferiority of Manzanilla Sophia® compared to Meticel Ofteno® 0.5% in providing a sensation of eye relief, through the score of an analogous visual test for eye fatigue
研究概览
简要总结
Demonstrate the non-inferiority of Manzanilla Sophia® compared to Meticel Ofteno® 0.5% in providing a sensation of eye relief, through the score of an analogous visual test for eye fatigue.
详细描述
Primary Objective:
Demonstrate the non-inferiority of Manzanilla Sophia® compared to Meticel Ofteno® 0.5% in providing a sensation of eye relief, through the score of an analogous visual test for eye fatigue.
Secondary Objectives:
Signs and Symptoms Evaluated:
- Compare Manzanilla Sophia® to Meticel Ofteno® 0.5% in the incidence of red eye.
- Compare Manzanilla Sophia® to Meticel Ofteno® 0.5% in the incidence of dry eye sensation.
- Compare Manzanilla Sophia® to Meticel Ofteno® 0.5% in the incidence of eye irritation.
- Compare Manzanilla Sophia® to Meticel Ofteno® 0.5% in the incidence of sensation of eye discharge (sleep).
- Compare Manzanilla Sophia® to Meticel Ofteno® 0.5% in the incidence of comfort with the application of the investigational product (IP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 是
入选标准
- •Ability to voluntarily provide signed informed consent.
- •Able and willing to comply with the scheduled visits, treatment plan, and other study procedures.
- •Be of legal age.
- •Women of reproductive age who have not undergone bilateral tubal ligation or hysterectomy must ensure the continued use (initiated ≥ 30 days prior to signing the - - Informed Consent Form [ICF]) of a hormonal contraceptive method or intrauterine device (IUD) during the study period.
- •A score of ≥ 3 on the analogous visual test for eye fatigue in at least 4 of the included questions.
排除标准
- •Pregnant women, breastfeeding women, or those planning to become pregnant during the study period.
- •Having participated in another clinical research study ≤ 30 days prior to the screening visit.
- •Having previously participated in this study.
- •Having only one functional eye.
- •A history of current or past drug addiction or substance dependence within the last two years prior to signing the ICF.
- •Current user of soft or hard contact lenses. They may be included if they suspend use during the study, and they must be lens-free for 15 days prior to inclusion.
- •Known hypersensitivity to the components of the investigational products.
研究组 & 干预措施
Manzanilla Sophia®
Matricaria recutita 0.025%. One drop four times per day (QID), with a minimun interval of 3 hours between administrations, for 7 days.
干预措施: Manzanilla Sophia® (Drug)
Meticel Ofteno® 0.5%
Hydroxypropyl methylcellulose 0.5%. One drop QID, with a minimun interval of 3 hours between administrations, for 7 days.
干预措施: Meticel Ofteno® 0.5% (Drug)
结局指标
主要结局
To demonstrate the non-inferiority of Manzanilla Sophia® compared to Meticel Ofteno® 0.5% in providing a sensation of eye relief, through the score of an analogous visual test for eye fatigue
时间窗: Day 0 (Basal visit), Day 8 (Final visit)
Score of the analogous visual test for eye fatigue. Based on other tools previously used for the assessment of eye fatigue, the visual analog test for eye fatigue used in this protocol is adapted and created. This test includes the following questions: "Have you had a headache?", "Have you had eye strain?", "Do you have gritty sensation in your eyes?", "Have your eyes been itchy?", "How would you describe your clarity of sight?", "Do you feel any discomfort when you fix your eyes?". Each of these questions will be answered according to a Likert scale of 1-5. The sum of the answers, the total score, will be measured in a scale from 6 to 30. A higher score is a a worse outcome for this variable.
次要结局
- Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the incidence of red eye(Day 0 (Basal visit), Day 8 (Final visit))
- Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the incidence of dry eye sensation.(Day 0 (Basal visit), Day 8 (Final visit))
- Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the incidence of eye irritation(Day 0 (Basal visit), Day 8 (Final visit))
- Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the incidence of sensation of eye discharge.(Day 0 (Basal visit), Day 8 (Final visit))
- Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the incidence of comfort with the application of the investigational product (IP).(Day 0 (Basal visit), Day 8 (Final visit))