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

Primary Purpose

Conjunctivitis, Bacterial

Status
Withdrawn
Phase
Phase 1
Locations
Mexico
Study Type
Interventional
Intervention
PRO-143 Ophthalmic Solution
Sponsored by
Laboratorios Sophia S.A de C.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Conjunctivitis, Bacterial focused on measuring PRO-143, Topical antibiotic, Ophthalmic antibiotic, External bacterial infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Independent Clinical Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PRO-143 Ophthalmic Solution

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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.
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
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.

Full Information

First Posted
February 22, 2012
Last Updated
October 8, 2018
Sponsor
Laboratorios Sophia S.A de C.V.
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1. Study Identification

Unique Protocol Identification Number
NCT03698045
Brief Title
Safety and Tolerability of PRO-143 Ophthalmic Solution in Healthy Volunteers.
Acronym
PRO-143
Official Title
Study to Evaluate the Safety and Tolerability of Pro-143 Ophthalmic Solution in Healthy Volunteers.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Withdrawn
Why Stopped
the clinical study was canceled by the sponsor due to logistics and programming
Study Start Date
November 2013 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
March 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratorios Sophia S.A de C.V.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conjunctivitis, Bacterial
Keywords
PRO-143, Topical antibiotic, Ophthalmic antibiotic, External bacterial infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRO-143 Ophthalmic Solution
Arm Type
Experimental
Arm Description
PRO-143 Ophthalmic Solution applied four times per day (c/6 hours) during 10 days.
Intervention Type
Drug
Intervention Name(s)
PRO-143 Ophthalmic Solution
Other Intervention Name(s)
PRO-143
Intervention Description
PRO-143 Ophthalmic Solution applied four times per day (C/6 hours) during 10 days.
Primary Outcome Measure Information:
Title
Conjunctival bulbar hyperemia
Description
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
Title
Number of Participants with adverse events
Description
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 Outcome Measure Information:
Title
Intraocular pressure (IOP)
Description
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
Title
Visual ability (VA)
Description
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
Title
Eye comfort index (ICO)
Description
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.
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José F Alaniz-De La O, MD
Organizational Affiliation
Independent Clinical Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laura R Saucedo-Rodíguez, MD
Organizational Affiliation
Independent Clinical Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leopoldo M Baiza-Durán, MD
Organizational Affiliation
Clinical Research Department. Laboratorios Sophia SA de CV
Official's Role
Study Director
Facility Information:
Facility Name
Independent Clinical Research Center
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44100
Country
Mexico

12. IPD Sharing Statement

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

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