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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Conjunctivitis, Bacterial
• Intervention / Treatment: Drug: PRO-143 Ophthalmic Solution

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: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44100
      • Independent Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRO-143 Ophthalmic Solution; PRO-143 Ophthalmic Solution applied four times per day (c/6 hours) during 10 days.	Drug: PRO-143 Ophthalmic Solution; PRO-143 Ophthalmic Solution applied four times per day (C/6 hours) during 10 days.; Other Names: PRO-143

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	10 days

Collaborators and Investigators

• Sponsor: Laboratorios Sophia S.A de C.V.
• Investigators: Study Director: Leopoldo M Baiza-Durán, MD, Clinical Research Department. Laboratorios Sophia SA de CV; 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 record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Anticipated): February 1, 2014
• Study Completion (Anticipated): March 1, 2014

Study Registration Dates

• First Submitted: February 22, 2012
• First Submitted That Met QC Criteria: October 3, 2018
• First Posted (Actual): October 5, 2018

Study Record Updates

• Last Update Posted (Actual): October 10, 2018
• Last Update Submitted That Met QC Criteria: October 8, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: PRO-143; Topical antibiotic; Ophthalmic antibiotic; External bacterial infections
• Additional Relevant MeSH Terms: Infections; Eye Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Conjunctival Diseases; Eye Infections, Bacterial; Eye Infections; Conjunctivitis; Conjunctivitis, Bacterial; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: SOPH143-0212/I; PRO-143