Clinical Study of Non-inferiority Between Manzanilla Sophia® and Meticel Ofteno® 0.5% for Providing a Soothing Sensation to the Eyes.
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 入组人数
- 100
- 主要终点
- Analog visual eyestrain test score
研究概览
简要总结
This is a phase IV clinical study to demonstrate the non-inferiority of Manzanilla Sophia® compared to Meticel Ofteno® 0.5% in providing restful sensation to the eyes. This will be evaluated by measuring the incidence of unexpected adverse events related to the interventions, the incidence of conjunctival hyperemia and the incidence of sensation of comfort with the application, when applied by the Principal Investigator (PI).
详细描述
Primary:
-Analog visual eyestrain test score
Secondary:
- Incidence of unexpected adverse events related to the interventions
- Incidence of conjunctival hyperemia
- Incidence of sensation of ocular dryness
- Incidence of ocular irritation
- Incidence of sensation of (sleep-crust)
- Incidence of sensation of comfort with the application, when applied by the Principal Investigator (PI)
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
- None
盲法说明
Open-label,
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
- •Having the ability to voluntarily give their signed informed consent.
- •Being able to and willing to comply with scheduled visits, treatment plan, and other study procedures.
- •Age ≥18 years.
- •Women of childbearing potential who have not undergone Bilateral Tubal Occlusion (BTO [Tubal Ligation]), hysterectomy, or bilateral oophorectomy must ensure continuation (initiated ≥ 30 days prior to signing the informed consent form [ICF]) of the use of a hormonal contraceptive method or intrauterine device (IUD) during the study period.
- •Present on the analog visual eyestrain test score ≥ 3 on at least 4 of the included questions.
排除标准
- •History of hypersensitivity to any of the components of the drugs under investigation.
- •Use of contact lenses for a period less than two weeks prior to the start of the study, and during the intervention period of this study.
- •In the case of women: being pregnant, breastfeeding, or planning to become pregnant within the study period.
- •Having participated in any clinical research study 30 days prior to inclusion in this study.
- •Having previously participated in this same study.
- •Having a single functional eye.
- •Having a history of drug addiction or drug dependence current or within the last two years prior to signing the informed consent.
- •Elimination Criteria:
- •Withdrawal of their consent to participate in the study (informed consent form).
- •Occurrence of a serious adverse event, whether related or not to the interventions, that in the opinion of the principal investigator (PI) and/or the sponsor, could affect the patient's fitness to safely continue with the study procedures.
- •Non-tolerability or hypersensitivity to any of the drugs under investigation.
研究组 & 干预措施
Manzanilla Sophia®
Matricaria recutita 0.025%, Ophthalmic solution.
- Dosage: 1 drop every 4 hours (4 daily applications [QID]), during 7 days.
- Route of administration: Topical ophthalmic.
干预措施: Manzanilla Sophia® (Drug)
Meticel Ofteno®
Hypromellose 0.5%. Ophthalmic solution.
- Dosage: 1 drop every 4 hours (4 daily applications [QID]), during 7 days
- Route of administration: Topical ophthalmic.
干预措施: Meticel Ofteno® (Drug)
结局指标
主要结局
Analog visual eyestrain test score
时间窗: Days: 0 (Basal Visit) and 8 (Final Visit).
The PI will evaluate the analog visual eyestrain test score by applying a direct questionnaire to the subject and allowing the subject to answer it calmly without any pressure. The analog visual test score is a questionnaire designed to establish the degree of eyestrain (fatigue) according to its symptomatology. This questionnaire will be as follows for frequency: never (1), sometimes (2), 50% of the time (3), almost all the time (4) and all the time (5).
次要结局
- Incidence of sensation of (sleep-crust)(Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit))
- Incidence of unexpected adverse events related to the interventions(Days 0 (Basal Visit), 3 (Visit 1), 8 (Final Visit) and 10 (Safety Call))
- Incidence of conjunctival hyperemia(Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit))
- Incidence of sensation of ocular dryness.(Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit))
- Incidence of ocular irritation(Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit))
- Incidence of sensation of comfort with the application, when applied by the Principal Investigator (PI)(Day 8 (Final Visit))