Phase I Clinical Trial, to Evaluate the Safety and Tolerability of the Ophthalmic Solution PRO-174 Versus Sophixín Ofteno®, Elaborated by Laboratorios Sophia 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
- 30
- 试验地点
- 1
- 主要终点
- Number of Adverse Events (EAS)
研究概览
简要总结
Phase I clinical trial, to evaluate the safety and tolerability of the ophthalmic solution PRO-174 versus Sophixín Ofteno®, elaborated by Laboratorios Sophia, S.A. of C.V. on the ocular surface of ophthalmologically and clinically healthy subjects.
Goals:
To evaluate the safety and tolerability of the formulation PRO-174 manufactured by Laboratorios Sophia, S.A. of C.V. on the ocular surface of clinically healthy subjects.
Hypothesis:
The ophthalmic solution PRO-174 presents a safety and tolerability profile similar to the comparator in healthy subjects.
详细描述
Phase I clinical trial, to evaluate the safety and tolerability of the ophthalmic solution PRO-174 versus Sophixín Ofteno®, elaborated by Laboratorios Sophia, S.A. of C.V. on the ocular surface of ophthalmologically and clinically healthy subjects.
Goals:
Methodology:
Phase I clinical trial, controlled, of parallel groups, double blind, randomized, exploratory.
Number of patients:
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. (Vital signs at rest: blood pressure ≤ 139/89 mmHg, heart rate 60 -100 beats per minute and respiratory rate of 12-24 breaths per minute).
- •Visual capacity 20/30 or better, in both eyes.
- •Intraocular pressure ≥11 and ≤ 21 mmHg.
排除标准
- •General criteria
- •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.
- •Pregnant or lactating women.
- •Women of childbearing age, who do not ensure a hormonal contraceptive method or intrauterine device during the study period or without a history of bilateral tubal obstruction, oophorectomy or hysterectomy; as fertile age we understand women who have not had their menopause, defined as 12 months since the last menstruation in women over 40 years.
- •Subjects with participation in clinical research studies 90 days prior to inclusion in the present study.
- •Diagnosis of liver disease or elevation to three times 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 amount and frequency)
- •Positive alcoholism (specified as the consumption of alcoholic beverages, regardless of quantity and frequency, during the study intervention period).
- •Contact lens users.
- •An occlusive iridocorneal angle, defined as a trabecular mesh visible at less than 90 ° from the angular circumference to gonioscopy.
研究组 & 干预措施
PRO-174
Active ingredient: Levofloxacin 0.5%
o Dosage: 1 drop in both eyes, 8 times a day during the waking period
干预措施: PRO-174 (Drug)
Sophixín Ofteno®
o Dosage: 1 drop in both eyes, 8 times a day during the waking period
干预措施: Sophixín Ofteno® (Drug)
结局指标
主要结局
Number of Adverse Events (EAS)
时间窗: during the 12 days of evaluation, including the safety call (day 12).
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.
Ocular Burning (OB)
时间窗: will be evaluated at the end of the treatment at the final visit (day 7)
primary tolerability variable Ocular burning is a nominal variable that will be evaluated by direct questioning to the research subject, then it will be staged according to the following scale: Severity: Absent, very mild, mild, moderate and severe, where the normality of severity is absent.
次要结局
- Intraocular Pressure (IOP)(will be evaluated at the end of the treatment at the final visit (day 7))
- Breakup Time (BUT)(will be evaluated at the end of the treatment at the final visit (day 7))
- Number of Eyes With Foreign Body Sensation (FBS) by Grade(will be evaluated at the end of the treatment at the final visit (day 7))
- Number of Eyes With Ocular Pruritus (P) by Grade(will be evaluated at the end of the treatment at the final visit (day 7))
- Visual Capacity(will be evaluated at the end of the treatment at the final visit (day 7))
- Percentage of Eyes With Conjunctival Hyperemia (CH) by Grade(will be evaluated at the end of the treatment at the final visit (day 7))
- Number of Eyes of Chemosis(will be evaluated at the end of the treatment at the final visit (day 7))
- Number of Eyes With Epithelial Defects (ED) by Grade(will be evaluated at the end of the treatment at the final visit (day 7))