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

Laboratorios Sophia S.A de C.V.

Overview

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

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

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Conjunctivitis, Bacterial

Interventions

PRO-143 Ophthalmic SolutionDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Independent Clinical Research Center

Guadalajara, Jalisco, Mexico

Outcomes

Primary Outcomes

Conjunctival bulbar hyperemia

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.

Time frame: 10 days

Number of Participants with adverse events

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

Time frame: 10 days

Secondary Outcomes

Intraocular pressure (IOP)

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.

Time frame: 10 days

Visual ability (VA)

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

Time frame: 10 days

Eye comfort index (ICO)

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.

Data from ClinicalTrials.gov

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