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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-03-31

Brief Summary

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

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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.

Conditions

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Conjunctivitis, Bacterial

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PRO-143 Ophthalmic Solution

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

Group Type EXPERIMENTAL

PRO-143 Ophthalmic Solution

Intervention Type DRUG

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

Interventions

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PRO-143 Ophthalmic Solution

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

Intervention Type DRUG

Other Intervention Names

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PRO-143

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes