Phase I Clinical Study, to Evaluate the Safety and Tolerability of the Preservative-free Ophthalmic Solution PRO-122 Compared With Krytantek Ofteno®, Elaborated by Sophia Laboratories, S.A. of C.V. on the Ocular Surface of Ophthalmologically and Clinically Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of Adverse Events
研究概览
简要总结
Therapeutic indication: Ocular hypotensive Use: Primary open-angle glaucoma and ocular hypertension.
Objectives: To evaluate the safety and tolerability of the preservative-free formulation PRO-122 manufactured by Sophia Laboratories, S.A. of C.V. on the ocular surface of clinically healthy subjects.
Hypothesis: The ophthalmic solution PRO-122 presents a profile of safety and tolerability similar to Krytantek Ofteno®, in healthy subjects.
Methodology: Phase I clinical trial, controlled, parallel group, double blind, randomized.
Number of patients: n=24 12 subjects per group (both eyes). Main inclusion criteria:Clinically healthy subjects.
详细描述
Number of patients: n = 24 12 subjects per group (both eyes). Main inclusion criteria: Clinically healthy subjects.
Treatment duration: 7 days. Duration of subject in the study: 15 to 22 days.
Adverse events will be reported and cataloged based on the MedDRA dictionary and will be reported to the corresponding regulatory entity.
The sponsor will carry out monitoring or quality visits to the research sites where it corroborates the information of the source documents and will contrast them with the information presented in the electronic CRF. Electronic case report forms will be evaluated by the clinical research associate and the clinical team of the sponsor (medical ophthalmologist researcher and pharmacologist of clinical safety).
Statistical methodology:
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Blinding will correspond to the principal investigator and coinvestigator. In addition, the statistical analysis will be carried out in a blinded manner for the final analysis. Blinding can not be guaranteed in the subject.
The masking will be done through the secondary container. The primary packaging will not be masked by the morphological difference between them. The sponsor and the research center will have two blind / non-blind teams.
They will be identified by means of identical labels. Which, in accordance with current and applicable regulations, must contain at least:
- Name, address and telephone number of the sponsor.
- Pharmaceutical form and route of administration.
- Lot Number.
- Caption "Exclusively for clinical studies"
- Date of Expiry
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
- •- Clinically healthy
- •Ability to give your signed informed consent, and show willingness to comply with study procedures and to modify your lifestyle activities (Section 6.2.2)
- •Age between 18 to 45 years.
- •Indistinct sex.
- •Women must ensure a hormonal contraceptive method or intrauterine device during the study period.
- •Blood tests: within normal parameters or with a range of ± 20% as long as the subject is clinically healthy.
- •Blood count (BH): Hemoglobin, erythrocytes, hematocrit, total leukocytes, platelets, mean corpuscular volume and mean corpuscular hemoglobin.
- •Blood chemistry of three elements (QS): Glucose, urea and creatinine.
- •Liver function tests (PFH): Aspartate Aminotransferase and Alanine Aminotransferase, total bilirubin, direct and indirect.
- •Visual ability 20/30 or better in both eyes.
- •Vital signs within normal parameters.
- •Intraocular pressure ≥10 and ≤ 21 mmHg.
排除标准
- •Users of topical ophthalmic products of any kind.
- •Users of medicines, or herbal products, by any other route of administration, with the exception of hormonal contraceptives in the case of women.
- •Women who are pregnant or breastfeeding.
- •Participation in clinical research studies 90 days prior to inclusion in the present study.
- •Previous participation in this same study.
- •Users of contact lenses.
- •History of any chronic-degenerative disease.
- •Inflammatory or infectious disease, active at the time of study entry.
- •Injuries or traumatisms not resolved at the time of admission to the study.
研究组 & 干预措施
PRO-122
- Dosage: 1 drop every 12 hours, in both eyes
干预措施: PRO-122 (Drug)
Krytantek Ofteno®
- Dosage: 1 drop every 12 hours, in both eyes
干预措施: Krytantek Ofteno® (Drug)
结局指标
主要结局
Number of Adverse Events
时间窗: during the 14 days of evaluation, including the safety call (day 14)
primary security variable the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent. it will be evaluated by the number of reported cases per group.
Eye Comfort Index
时间窗: will be evaluated at the end of the treatment, at the final visit (day 8)
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. Values closer or equal to one hundred (100) correspond to greater discomfort, while values closer or equal to zero (0) correspond to greater comfort.
次要结局
- Number of Eyes With Epithelial Defects by Grade(will be evaluated at the end of the treatment, at the final visit (day 8))
- Participants With Chemosis(will be evaluated at the end of the treatment, at the final visit (day 8))
- Visual Ability(will be evaluated at the end of the treatment, at the final visit (day 8))
- Participants With Conjunctival Hyperemia (CH) by Grade(will be evaluated at the end of the treatment, at the final visit (day 8))