Phase I Clinical Study, to Evaluate the Safety and Tolerability of the Preservative-free Ophthalmic Solution PRO-087 Versus Xyel Ofteno® and Systane Ultra®, 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
- 30
- 试验地点
- 1
- 主要终点
- Goblet Cell Density (GCD)
研究概览
简要总结
Phase I clinical study, to evaluate the safety and tolerability of the preservative-free ophthalmic solution PRO-087 versus Xyel Ofteno® and Systane Ultra®, on the ocular surface of ophthalmological and clinically healthy subjects.
Objective: To evaluate the safety and tolerability of the preservative-free formulation PRO-087 manufactured by Laboratorios Sophia S.A. of C.V. on the ocular surface of clinically healthy subjects.
Hypothesis:
The ophthalmic solution PRO-087 presents a profile of safety and tolerability similar to comparators in healthy subjects
Methodology:
Phase I clinical trial, controlled, of parallel groups, double blind, randomized, exploratory.
详细描述
Phase I clinical study, to evaluate the safety and tolerability of the preservative-free ophthalmic solution PRO-087 versus Xyel Ofteno® and Systane Ultra®, on the ocular surface of ophthalmological and clinically healthy subjects.
Objective: To evaluate the safety and tolerability of the preservative-free formulation PRO-087 manufactured by Laboratorios Sophia S.A. of C.V. on the ocular surface of clinically healthy subjects.
Hypothesis:
The ophthalmic solution PRO-087 presents a profile of safety and tolerability similar to comparators in healthy subjects
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Blinding It will consist in the elimination of the primary label (commercial) in the case of Xyel Ofteno® and Systane Ultra® and the placement of a label identical to the other interventions. Because the bottle in which Systane Ultra® is packaged differs in the color and shape of the lid used by Xyel Ofteno® and PRO-087, a masking will be carried out on the primary packaging which will be identical for the three interventions.The allocation sequence will be generated by personnel assigned. The research center will receive a set of envelopes which will contain the intervention number individually. The envelopes will be identical on the outside. Each of these envelopes will be shown to the participants for their election by the principal investigator or by a designated member of their team.
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 all analysis.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically and ophthalmologically healthy subjects
- •Signed informed consent.
- •Age between 18 to 40 years.
- •Both genders
- •Blood tests [complete blood count (BHC), three element blood chemistry (QS) and liver function tests (PFH)] within normal parameters
- •Visual capacity 20/30 or better
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 or hysterectomy, 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).
- •Users of contact lenses.
研究组 & 干预措施
PRO-087
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: chondroitin sulfate 0.18%, sodium hyaluronate 0.1% ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.
干预措施: PRO-087 (Drug)
Xyel Ofteno
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days, Active principles: Xanthan gum 0.9 mg, sodium chondroitin sulfate 1.0 ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.
干预措施: Xyel Ofteno (Drug)
Systane ultra
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: Polyethylene glycol 400 0.4%, propyleneglycol 0.3%, Ophthalmic solution, multi-dose dropper bottle, made by Alcon Laboratories, Inc.
干预措施: Systane Ultra (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 10)
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
- Conjunctival Hyperemia (CH)(will be evaluated at the end of the treatment at the final visit (day 10))
- Presence of Adverse Events (AEs)(during the 13 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 10))
- Epithelial Defects (ED)(will be evaluated at the end of the treatment at the final visit (day 10))
- Breakup Time (BUT)(will be evaluated at the end of the treatment at the final visit (day 10))
- Chemosis(will be evaluated at the end of the treatment at the final visit (day 10))
- Ocular Burning (OB)(will be evaluated at the end of the treatment at the final visit (day 10))
- Foreign Body Sensation (FBS)(will be evaluated at the end of the treatment at the final visit (day 10))
- Ocular Pruritus (P)(will be evaluated at the end of the treatment at the final visit (day 10))