Phase I Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution Compared to Lagricel® Ofteno Single Dose on the Ocular Surface of Clinically Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Presence of Adverse Events (AEs)
研究概览
简要总结
Study design: Phase I clinical trial, single-center, controlled, parallel group, open, randomized.
Number of subjects: n = 34 evaluable subjects, 17 evaluable subjects per group (both eyes).
Estimated duration of the study: 5 months
Therapeutic indication: Eye lubricant Use: Dry Eye
Objective:To evaluate the safety and tolerability of Lagricel® Ofteno multidose manufactured by Laboratorios Sophia on the ocular surface of clinically healthy subjects.
Hypothesis:
H0 = Lagricel® Ofteno multidose ophthalmic solution has a safety and tolerability profile similar to Lagricel® Ofteno single dose in healthy subjects.
H1 = Lagricel® Ofteno multidose ophthalmic solution has a different safety and tolerability profile than Lagricel® Ofteno single dose in healthy subjects.
Main inclusion criteria: Clinically healthy subjects
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
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To be clinically healthy
- •To have the ability to voluntarily grant your signed informed consent
- •To have the willingness to comply with scheduled visits treatment plan and other study procedures
- •Women in reproductive age should ensure the continuation (initiated ≥ 30 days prior to the signing of the informed consent) to use a hormonal contraceptive method or intrauterine device during the study period.
- •To have a better corrected visual acuity of 20/30 or better in both eyes.
- •To have vital signs in normal parameters.
- •To have an intraocular pressure between ≥10 and ≤ 21 mmHg.
排除标准
- •To be user of ophthalmic topical products of any kind.
- •To be user of medicines, or herbal products, by any other route of administration.
- •In the case of women: being pregnant, breastfeeding or planning to get pregnant in the study period.
- •Having participated in clinical research studies 90 days prior to inclusion in this study.
- •Having previously participated in this same study.
- •To be a user of contact lenses and can not suspend their use during the study.
- •Having initiated the use of hormonal contraceptives or intrauterine devices, 30 days prior to inclusion in the present study.
- •To have a history of any chronic degenerative disease.
- •Having inflammatory or infectious disease, active at the time of admission to the study.
- •Having injuries or unresolved injuries at the time of admission to the study.
- •Having a history of any type of eye surgery.
- •Having undergone surgical procedures, not ophthalmological, in the last 3 months.
- •To be or to have an immediate family member (for example: spouse, parent / legal guardian, brother or child) who is part of the research site staff or the sponsor who participates directly in this study.
研究组 & 干预措施
Lagricel® Ofteno Multidose
Lagricel® Ofteno Multidose 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia
干预措施: lagricel ofteno multidose (Drug)
Lagricel® Ofteno Single dose
Lagricel® Ofteno single dose. 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia
干预措施: lagricel ofteno single dose (Drug)
结局指标
主要结局
Presence of Adverse Events (AEs)
时间窗: during the 10 days of evaluation, including the safety call (day 11).
the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent
Eye Comfort Index (ECI)
时间窗: will be evaluated at the end of the treatment (day 8, final visit)
It is a questionnaire designed to measure the irritation of the ocular surface with Rasch analysis to produce estimates on a linear scale of intervals (ratings: 0-100).The Eye comfort index contains items that focus on the discomfort associated with alterations of the ocular surface.(0: None discomfort, 100: high discomfort).
次要结局
- Conjunctival Hyperemia (CH)(will be evaluated at the end of the treatment (day 8, final visit))
- Epithelial Defects (ED) Fluorescein Stain(will be evaluated at the end of the treatment (day 8, final visit))
- Visual Acuity (VA)(will be evaluated at the end of the treatment (day 8, final visit))
- Epithelial Defects (ED) Green Lissamine(will be evaluated at the end of the treatment (day 8, final visit))
- Chemosis(will be evaluated at the end of the treatment (day 8, final visit))