Phase I Clinical Study, to Evaluate the Safety and Tolerability of the Ophthalmic Solution PRO-179 Compared With Travatan®, 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
- 24
- 试验地点
- 1
- 主要终点
- Eye Comfort Index
研究概览
简要总结
Phase I clinical study, to evaluate the safety and tolerability of the ophthalmic solution PRO-179 compared with Travatan®, on the ocular surface of clinically healthy subjects.
Goals: To evaluate the safety and tolerability of the formulation PRO-179 manufactured by Sophia Laboratories S.A. of C.V. on the ocular surface of clinically healthy subjects.
Hypothesis:The ophthalmic solution PRO-179 presents a profile of safety and tolerability similar to Travatan® in healthy subjects.
Methodology: Clinical trial Phase I, controlled, of parallel groups, double blind, with randomization.
详细描述
Number of patients: n= 24, 12 subjects per group (both eyes). Main inclusion criteria: Clinically healthy subjects.
duration: 10 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).
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 teams blinded / not blinded.
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.
- Legend "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
- •Be clinically healthy.
- •Have the ability to give their signed informed consent and show willingness to comply with the study procedures
- •Have an age between 18 to 45 years.
- •Indistinct sex.
- •Women should ensure the continued use of a hormonal contraceptive method or intrauterine device (IUD) during the study period.
- •Present 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.
- •Present visual ability 20/30 or better in both eyes.
- •Present vital signs within normal parameters.
- •Present intraocular pressure ≥10 and ≤ 21 mmHg.
排除标准
- •Be a user of topical ophthalmic products of any kind.
- •Be a user of medicines, or herbal products, by any other route of administration, with the exception of hormonal contraceptives in the case of women.
- •In case of being a woman, being pregnant or breastfeeding.
- •Have participated in clinical research studies 90 days prior to inclusion in the present study.
- •Have previously participated in this same study.
- •Be a user of contact lenses and can not suspend their use during the study.
- •That they can not follow the lifestyle considerations described in section 6.2.2
- •Having started the use of hormonal contraceptives or IUD, 30 days prior to inclusion in the present study.
- •Having a history of any chronic-degenerative disease.
- •Present inflammatory or infectious disease, active at the time of admission to the study.
- •Present injuries or unresolved traumas at the time of entering the study.
- •Having the antecedent of any type of eye surgery.
- •Having undergone surgical procedures, not ophthalmological, in the last 3 months.
研究组 & 干预措施
PRO-179
Dosage: 1 drop every 24 hours, at night, in both eyes.
干预措施: PRO 179 (Drug)
Travatan®
Dosage: 1 drop every 24 hours, at night, in both eyes.
干预措施: Travatan 0.004 % Ophthalmic Solution (Drug)
结局指标
主要结局
Eye Comfort Index
时间窗: will be evaluated at the end of the treatment, at the final visit (day 11)
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).
Number of Participants With 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.
次要结局
- Percentage of Eyes With Conjunctival Hyperemia (CH) by Grade(will be evaluated at the end of the treatment, at the final visit (day 11))
- Number of Eyes of Chemosis(will be evaluated at the end of the treatment, at the final visit (day 11))
- Number of Eyes With Epithelial Defects by Grade(will be evaluated at the end of the treatment, at the final visit (day 11))
- Visual Ability(will be evaluated at the end of the treatment, at the final visit (day 11))