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

Conjunctivitis, Bacterial Clinical Trial

— PRO-143  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03698045
• Other study ID #: SOPH143-0212/I
• Secondary ID: PRO-143
• Status: Withdrawn
• Phase: Phase 1
• Start date: November 2013
• Est. completion date: March 2014

Study information

• Verified date: October 2018
• Source: Laboratorios Sophia S.A de C.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Conjunctivitis
• Conjunctivitis, Bacterial

Intervention

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

Locations

Country	Name	City	State
Mexico	Independent Clinical Research Center	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Sophia S.A de C.V.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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