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

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

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

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

Conditions
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Conjunctivitis, Bacterial

Intervention / Treatment
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* Drug: PRO-143 Ophthalmic Solution


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PRO-143, Topical antibiotic, Ophthalmic antibiotic, External bacterial infections