Safety and Tolerability of PRO-143 Ophthalmic Solution in Healthy Volunteers.

赞助:

合作者:

信息的提供 (责任方):

，

追踪信息

首次提交日期 ^ICMJE

February 22, 2012

首次发布日期e ^ICMJE

October 5, 2018

最后更新发布日期

October 5, 2018

预计研究开始日期 ^ICMJE

November 2013

预计主要完成日期

February 2014 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Conjunctival bulbar hyperemia[ Time Frame: 10 days ]

Conjunctival hyperemia is defined as the simplest reaction of the conjunctiva to a stimulus, a red appearance secondary to the vasodilation of the conjunctival vessels of variable intensity. He will graduate using the Efron scale. 0 Normal , 1 Very slight, 2 Mild, 3 Moderate, 4 Severe.

Adverse events[ Time Frame: 10 days ]

he evaluation of adverse events requires a questioning conducted by the principal investigator and the appropriate exploratory techniques for its detection. the number of adverse events per study group will be considered for the analysis

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Intraocular pressure (IOP)[ Time Frame: 10 days ]
Tonometry is the objective measure of Intraocular pressure, based primarily on the force required to flatten the cornea, or the degree of corneal indentation produced by a fixed force. Goldman's tonometry is based on the Imbert-Fick principle. the result will be expressed in millimeters of mercury and the comparison between groups will be carried out.
Visual ability (VA)[ Time Frame: 10 days ]
The VA will be evaluated basally, without refractive correction with the Snellen chart. Which will be located in a place with adequate lighting, natural or artificial and at a distance of 3 meters from the subject to be evaluated
Eye comfort index (ICO)[ Time Frame: 10 days ]
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). 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.

描述性信息

简略标题 ^ICMJE

Safety and Tolerability of PRO-143 Ophthalmic Solution in Healthy Volunteers.

正式标题 ^ICMJE

Study to Evaluate the Safety and Tolerability of Pro-143 Ophthalmic Solution in Healthy Volunteers.

简要概况

Study to evaluate the safety and tolerability of PRO-143 solution ophthalmic in healthy volunteers.

详细说明

A phase I, open label and unicentric clinical trial to evaluate the safety and tolerability of PRO-143 ophthalmic solution in healthy volunteers.

研究类型 ^ICMJE

Interventional

研究阶段

Phase 1

研究设计 ^ICMJE

分配:
干预模型: Single Group Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Drug: PRO-143 Ophthalmic Solution
PRO-143 Ophthalmic Solution applied four times per day (C/6 hours) during 10 days.

研究工具

Experimental: PRO-143 Ophthalmic Solution
PRO-143 Ophthalmic Solution applied four times per day (c/6 hours) during 10 days.

招募信息

招募状态 ^ICMJE

Withdrawn

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

March 2014

预计主要完成日期

February 2014 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - Healthy male and female. - Age ≥ 18 years old at screening visit. Exclusion Criteria: - Any ocular or systemic condition. - Patient with one blind eye. - Visual acuity of 20/40 in any eye. - Use of ocular or systemics medications. - Contraindications or sensitivity to any component of the study treatments. - Contact lens users. - Ocular surgery within the past 3 months.. - Women who were not using an effective means of contraception or who were pregnant or nursing. - Participation in any studies of investigational drugs within 90 days previous to the inclusion.

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

Mexico

管理信息

数据检测委员会

Yes

研究涉及美国FDA监管的产品

研究美国FDA监管的药品:
研究涉及美国FDA监管的设备产品:

IPD 共享声明

计划分享 IPD:

责任方

，

研究赞助商 ^ICMJE

Laboratorios Sophia S.A de C.V.

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: José F Alaniz-De La O, MD Independent Clinical Research Center
Principal Investigator: Laura R Saucedo-Rodíguez, MD Independent Clinical Research Center
Study Director: Leopoldo M Baiza-Durán, MD Clinical Research Department. Laboratorios Sophia SA de CV

PRS 账户

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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