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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

February 22, 2012

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

November 2013

Estimated Primary Completion Date

February 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^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

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^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.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation:
Intervention Model: Single Group Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

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

Study Arms

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

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

March 2014

Estimated Primary Completion Date

February 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria ^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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Mexico

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Laboratorios Sophia S.A de C.V.

Collaborators ^ICMJE

Investigators ^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 Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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