Safety and Tolerability of PRO-155 Ophthalmic Solution 0.09% in Healthy Volunteers.

Laboratorios Sophia S.A de C.V.35 enrolled

Overview

Study to evaluate the safety and tolerability of PRO-155 Ophthalmic Solution 0.09 % in healthy volunteers.

A phase I, open label and unicentric clinical trial to evaluate the safety and tolerability of PRO-155 Ophthalmic Solution 0.09 % in healthy volunteers.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Inflammation Cataract

Interventions

BromfenacDRUG

Drug: Bromfenac Other names: PRO-155

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 systemic 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.

Locations (1)

Unidad Medica "Grupo Pediátrico"

Guadalajara, Jalisco, Mexico

Outcomes

Primary Outcomes

Visual Acuity

A Snellen chart is an eye chart that can be used to measure visual acuity. consisting of a scale ranging from 20 to 200, where 20 is the best visual capacity and 200 is the worst

Time frame: 10 days

Secondary Outcomes

Adverse Events

will be reported the presence of adverse events presented in the study group during the intervention period .

Time frame: 10 days

Findings in Posterior Segment

Abnormal bores will be reported when assessing the integrity of the posterior segment, the unit of measure will be number of findings.

Time frame: 10 days

Intraocular Pressure (IOP)

Intraocular pressure (IOP) measurement by applanation tonometry. The unit of measurement will be millimeters of mercury (mmhg) the normal range will be considered 11 to 21 mmhg.

Time frame: 10 days

Hyperemia

The red eye will be evaluated by the absence or presence of hyperemia.

Time frame: 10 days

Burning

Eye ocular burning will be reported according to the following scale: absent, mild, moderate and severe.

Time frame: 10 days

Tearing

Tearing will be reported according to the following scale: absent, mild, moderate and severe.

Time frame: 10 days

Foreign Body Sensation

Data from ClinicalTrials.gov

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