Phase I Clinical Study, to Evaluate the Safety and Tolerability of the Ophthalmic Gel PRO-167 Versus Corneregel®, on the Ocular Surface of Ophthalmological 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
- Goblet Cell Density (GCD)
研究概览
简要总结
Title of the study:
Phase I clinical trial, to evaluate the safety and tolerability of the ophthalmic gel PRO-167 versus Corneregel®, on the ocular surface of ophthalmological and clinically healthy subjects.
Methodology:
Phase I clinical trial, controlled, of parallel groups, double blind, randomized, exploratory.
Goals:
To evaluate the safety and tolerability of the ophthalmic gel PRO-167 manufactured by Laboratorios Sophia S.A. of C.V. on the ocular surface of clinically healthy subjects.
Hypothesis:
Ophthalmic gel PRO-167 has a safety and tolerability profile similar to that of its comparator in healthy subjects.
详细描述
Therapeutic indication:
Corneal surface reepithelizing
Statistical methodology:
The data will be expressed with measures of central tendency: mean and standard deviation for the quantitative variables. The qualitative variables will be presented in frequencies and percentages. The statistical analysis will be carried out through the Mann-Whitney U test for quantitative variables. The difference between the qualitative variables will be analyzed by means of square chi (Chi2). An alpha ≤ 0.05 will be considered significant.
Study period:
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The blinding will correspond to the research subject and the principal investigator. In addition, the statistical analysis will be carried out in a blinded manner for the partial and final analysis.
The masking will be done using boxes in the primary packaging identical in the two groups. Blinding for the research subject and the researcher will be done by replacing the commercial labels in the case of the comparator in the bottles and the use of identical labels that contain the allocation number.
Blinding may be opened in the following cases:
- Presence of a serious adverse event.
- Safety alarm due to the use of the drugs under study.
- In case the sponsor determines it for any reason of security or other reason that considers pertinent.
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
- •Signed informed consent.
- •Systemically and ophthalmologically healthy subjects evaluated during the clinical history.
- •Age between 18 to 45 years.
- •Both genders.
- •Blood tests [complete blood count, blood chemistry of three elements and liver function tests within normal parameters specified by the reference laboratory with a lower and upper margin of 10%.
- •Vital signs within normal parameters.
- •Visual capacity 20/30 or better, in both eyes.
- •Intraocular pressure ≥11 and ≤ 21 mmHg.
排除标准
- •Subjects with a history of hypersensitivity to any of the components of the research products.
- •Subject users of topical ophthalmic medications of any pharmacological group.
- •Subject users of medication by any other route of administration.
- •Women who are pregnant or breastfeeding.
- •Women without a history of hysterectomy, oophorectomy, who do not ensure a hormonal contraceptive method or intrauterine device during the study period.
- •Subjects with participation in clinical research studies 90 days prior to inclusion in the present study.
- •Diagnosis of liver disease or triple the normal upper value of any of the following liver enzymes: aspartate transferase (AST), alanine transferase (ALT) or bilirubin.
- •Inability to attend or answer the evaluations made in each of the visits.
- •Positive smoking (specified as cigarette consumption regardless of quantity and frequency)
- •Positive alcoholism (specified as the consumption of alcoholic beverages, regardless of quantity and frequency, during the study intervention period)
- •Contact lens users
研究组 & 干预措施
PRO-167
Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom
干预措施: PRO-167 (Drug)
Corneregel®
Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom of the right eye sac.
干预措施: Corneregel (Drug)
结局指标
主要结局
Goblet Cell Density (GCD)
时间窗: will be evaluated at the end of the treatment at the final visit (day 11)
the cells will be measured per square millimeter, it is a continuous variable taken by means of cytology per impression, the normal value is higher than 500 cells per square millimeter
次要结局
- Chemosis(will be evaluated at the end of the treatment at the final visit (day 11))
- Presence of Adverse Events (EAS)(during the 11 days of evaluation, including the safety call (day 13).)
- Intraocular Pressure (IOP)(will be evaluated at the end of the treatment at the final visit (day 11))
- Epithelial Defects (ED)(will be evaluated at the end of the treatment at the final visit (day 11))
- Breakup Time (BUT)(will be evaluated at the end of the treatment at the final visit (day 11))
- Conjunctival Hyperemia (CH)(will be evaluated at the end of the treatment at the final visit (day 11))
- Ocular Burning (OB)(will be evaluated at the end of the treatment at the final visit (day 11))
- Foreign Body Sensation (FBS)(will be evaluated at the end of the treatment at the final visit (day 11))
- Ocular Pruritus (P)(will be evaluated at the end of the treatment at the final visit (day 11))