Phase I Clinical Study, to Evaluate the Safety and Tolerability of the Ophthalmic Gel PRO-165 Versus Artelac® Nightime Gel, 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
- 32
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
Objective: To assess the safety and tolerability of the PRO-165 formulation on the ocular surface of ophthalmologically and clinically healthy subjects.
Hypothesis: Ophthalmic gel PRO-165 presents a safety and tolerability profile similar to Artelac® Nightime Gel in ophthalmological and clinically healthy subjects.
Phase I clinical study, controlled, of parallel groups, double blind, randomized, exploratory Therapeutic indication of PRO-165: Eye lubricant
详细描述
The study subjects will be recruited from various research centers in western and central Mexico.
Each research center has a monitoring plan specified according to the recruitment capabilities of the same, which must be at least once a month, where the queries of your data entered into the electronic case report report will be reported to the center. (e-CRF) for which it has as time limit the next monitoring visit to make the pertinent changes.
The report of adverse events will be made according to the standard operating procedure (PNO) where it specifies, according to Official Mexican Standard 220 (NOM 220), that the signs or symptoms of adverse events will be reported based on the Medical Dictionary. for Regulatory Activities, for which the sponsor has version 20.1 in Spanish. For serious adverse events (SAEs) will be reported in accordance with the standardized operation procedure of pharmacovigilance of the sponsor, which adheres to the guidelines of NOM 220 and international regulations, these will be reported in the regulatory framework to the regulatory entity within a period of time no more than 7 days.
The study is registered in the National Registry of Clinical Trials (RNEC), entity equivalent to Clinical Trials in Mexico.
The quality assurance plan is carried out by the sponsor through the Quality Assurance agent in Clinical Research, whose function is to conduct inspections and audits of the research sites to document and generate reports of deviations from the protocol. In addition to the visits of the monitoring plan, the reliability of the data is guaranteed.
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 (Participant, Investigator)
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 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
- •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, three element blood chemistry 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
- •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 lactating.
- •Women without a history of bilateral tubal obstruction, 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.
- •Known diagnosis of liver disease
- •Inability to attend or answer the evaluations made in each of the visits.
- •Positive tobacco use (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.
- •Medical and therapeutic exclusion criteria.
- •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 entry into the study.
研究组 & 干预措施
PRO-165
Dose: one drop of gel, 4 times a day during the waking period, in the bottom of the right eye sac
干预措施: PRO-165 (Drug)
1. Artelac® Nightime Gel
Dose: one drop of gel, 4 times a day during the waking period, in the bottom of the right eye sac
结局指标
主要结局
Adverse Events
时间窗: Throughout the 13 days of evaluation, including the safety call (day 13).
The Principal Investigator will register the Events Adverse (EA) that the subjects of the study will present. The EAs will be expressed as absent or present and the number of cases will be counted by study group.
Ocular Comfort Index
时间窗: Baseline Visit (day 0) and 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). A higher score is a worse outcome. Similar to the index for ocular surface diseases, the ocular comfort index (ICO) evaluates symptoms. The ICO contains 6 items that focus on the discomfort associated with the ocular surface. Each of these questions has two parts, which inquire separately the frequency and severity of the symptoms. The evaluator will deliver the questionnaire to the subject and allow the subject to answer it calmly without any pressure and / or coercion, will only assist him if he has difficulty understanding any of the questions.
次要结局
- Visual Acuity (VA)(Baseline Visit (day 0), Visit 1 (day 5), and Final Visit (day 11))
- Intraocular Pressure (IOP)(Baseline Visit (day 0), Visit 1 (day 5), and Final Visit (day 11).)
- Number of Participants With Post-instillation Symptomatology(Final Visit (day 11))
- Tear Breakup Time (TBUT)(Baseline Visit (day 0), Visit 1 (day 5), and Final Visit (day 11).)
- Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale)(Baseline Visit (day 0), Visit 1 (day 5), and Final Visit (day 11).)